Pharmacokinetics

Worcester, MA, United States

Pharmacokinetics

Worcester, MA, United States
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BOSTON, May 24, 2017 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today that data from its omadacycline clinical and microbiology programs will be presented at ASM Microbe 2017, to be held June 1 – 5 in New Orleans. Paratek is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry. “As we advance our clinical program, we continue to be encouraged by the study outcomes that add to our breadth of knowledge about the safety and efficacy of once-daily oral and IV omadacycline in the treatment of bacterial infections,” said Evan Loh, M.D., President, Chief Operating Officer, and Chief Medical Officer, Paratek. “Results from the 10 studies being presented at ASM Microbe include new phase 1 data examining omadacycline in patients with uncomplicated urinary tract infection as well as additional analyses of microbiology date that help further our understanding of how omadacycline may be used in a clinical setting. We continue to be excited about the potential for this compound to treat severe bacterial infections, particularly when resistance is of concern.” Paratek Presentations on Friday, June 2, 2017 at 12:45 p.m. – 2:45 p.m. CDT (1:45 p.m. – 3:45 p.m. EDT) Poster Session 45: Infection Prevention and Control: Skin, Soft Tissue and Bone Infections Paratek Presentations on Saturday, June 3, 2017 at 12:15 p.m. – 2:15 p.m. CDT (1:15 p.m. – 3:15 p.m. EDT) Poster Session 185: Antibacterial Resistance: In vitro Activity and Resistance to Tigecyline, Fosfomycin and Derivatives Paratek Presentations Sunday, June 4, 2017 at 12:15 p.m. – 2:15 p.m. CDT (1:15 p.m. – 3:15 p.m. EDT) Poster Session 341: Antimicrobial Pharmacokinetics: PK/PD of New Antimicrobial Agents Poster Session 345: Clostridium difficile: Epidemiology and Strategies for Prevention and Treatment of CD Infections About Paratek Pharmaceuticals, Inc. Paratek Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry. Paratek's lead product candidate, omadacycline, when approved, will be the first in a new class of tetracyclines known as aminomethylcyclines, with broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria. Omadacycline is a new, once-daily oral and intravenous broad spectrum antibiotic being developed for use as empiric monotherapy for patients suffering from serious community-acquired bacterial infections, such as acute bacterial skin and skin structure infections, community-acquired bacterial pneumonia, urinary tract infections, and other community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians. Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration for the target indications. In June 2016, Paratek announced positive efficacy data in a Phase 3 registration study in acute bacterial skin and skin structure infections (ABSSSI) demonstrating the efficacy and general safety and tolerability of intravenous (IV) to once-daily oral omadacycline compared to linezolid. In April 2017, Paratek announced positive efficacy data in a Phase 3 registration study in community-acquired bacterial pneumonia (CABP) demonstrating the efficacy and general safety and tolerability of IV to once-daily oral omadacycline compared to moxifloxacin. A Phase 3 registration study in ABSSSI comparing once-daily oral-only dosing of omadacycline to twice-daily oral-only dosing of linezolid was initiated in August 2016. This study completed enrollment in May 2017 and top-line data are expected in mid-July. The Company plans to submit its new drug application (NDA) in the U.S. as early as the first quarter of 2018 with an EMA submission later in 2018. In addition to its Phase 3 program for omadacycline, a Phase 1B study in uncomplicated urinary tract infections (UTI) was initiated in May 2016 and positive top-line PK proof-of-principle data was reported in November 2016. The Company plans to begin enrolling patients in a proof-of-concept Phase 2 study of omadacycline in acute pyelonephritis, the most common subset of complicated urinary tract infections, as early as December 2017. In October 2016, Paratek announced a research agreement with the U.S. Department of Defense to explore the utility of omadacycline against pathogenic agents causing infectious diseases of public health and biodefense importance including plague and anthrax. In April 2017, Paratek Bermuda Ltd., a wholly-owned subsidiary of the Company, and Zai Lab (Shanghai) Co., Ltd., entered into a License and Collaboration Agreement. Under the terms of the Agreement, the Company granted Zai an exclusive license to develop, manufacture, and commercialize omadacycline in the People’s Republic of China, Hong Kong, Macau and Taiwan, for all human therapeutic and preventative uses, other than biodefense. Paratek's second Phase 3 product candidate, sarecycline, is a well-tolerated, once-daily oral, narrow spectrum tetracycline-derived antibiotic with potent anti-inflammatory properties for the potential treatment of acne and rosacea in the community setting. Allergan owns the U.S. rights for the development and commercialization of sarecycline. Paratek retains all ex-U.S. rights. Allergan and Paratek reported positive results from two identical Phase 3 registration studies of sarecycline for the treatment of moderate to severe acne vulgaris in March 2017. Allergan has publicly announced plans to submit an NDA in the U.S. in the second half of 2017. Forward Looking Statements This press release contains forward-looking statements including statements related to our overall strategy, product candidates, clinical studies, prospects, potential and expected results, including statements about the timing of advancing omadacycline and otherwise preparing for clinical studies, the timing of enrollment in our clinical studies and our reporting of the results of such studies, the potential for omadacycline to serve as an empiric monotherapy treatment option for patients suffering from ABSSSI, CABP, UTI, and other bacterial infections when resistance is of concern, the prospect of omadacycline providing broad-spectrum activity, and our ability to obtain regulatory approval of omadacycline All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "believe," "expect," "well positioned," "look forward," "anticipated," "continued," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties.  We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements.  Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties.  These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2016, and our other filings with the Securities and Exchange Commission.  We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.


BOSTON, May 24, 2017 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today that data from its omadacycline clinical and microbiology programs will be presented at ASM Microbe 2017, to be held June 1 – 5 in New Orleans. Paratek is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry. “As we advance our clinical program, we continue to be encouraged by the study outcomes that add to our breadth of knowledge about the safety and efficacy of once-daily oral and IV omadacycline in the treatment of bacterial infections,” said Evan Loh, M.D., President, Chief Operating Officer, and Chief Medical Officer, Paratek. “Results from the 10 studies being presented at ASM Microbe include new phase 1 data examining omadacycline in patients with uncomplicated urinary tract infection as well as additional analyses of microbiology date that help further our understanding of how omadacycline may be used in a clinical setting. We continue to be excited about the potential for this compound to treat severe bacterial infections, particularly when resistance is of concern.” Paratek Presentations on Friday, June 2, 2017 at 12:45 p.m. – 2:45 p.m. CDT (1:45 p.m. – 3:45 p.m. EDT) Poster Session 45: Infection Prevention and Control: Skin, Soft Tissue and Bone Infections Paratek Presentations on Saturday, June 3, 2017 at 12:15 p.m. – 2:15 p.m. CDT (1:15 p.m. – 3:15 p.m. EDT) Poster Session 185: Antibacterial Resistance: In vitro Activity and Resistance to Tigecyline, Fosfomycin and Derivatives Paratek Presentations Sunday, June 4, 2017 at 12:15 p.m. – 2:15 p.m. CDT (1:15 p.m. – 3:15 p.m. EDT) Poster Session 341: Antimicrobial Pharmacokinetics: PK/PD of New Antimicrobial Agents Poster Session 345: Clostridium difficile: Epidemiology and Strategies for Prevention and Treatment of CD Infections About Paratek Pharmaceuticals, Inc. Paratek Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry. Paratek's lead product candidate, omadacycline, when approved, will be the first in a new class of tetracyclines known as aminomethylcyclines, with broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria. Omadacycline is a new, once-daily oral and intravenous broad spectrum antibiotic being developed for use as empiric monotherapy for patients suffering from serious community-acquired bacterial infections, such as acute bacterial skin and skin structure infections, community-acquired bacterial pneumonia, urinary tract infections, and other community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians. Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration for the target indications. In June 2016, Paratek announced positive efficacy data in a Phase 3 registration study in acute bacterial skin and skin structure infections (ABSSSI) demonstrating the efficacy and general safety and tolerability of intravenous (IV) to once-daily oral omadacycline compared to linezolid. In April 2017, Paratek announced positive efficacy data in a Phase 3 registration study in community-acquired bacterial pneumonia (CABP) demonstrating the efficacy and general safety and tolerability of IV to once-daily oral omadacycline compared to moxifloxacin. A Phase 3 registration study in ABSSSI comparing once-daily oral-only dosing of omadacycline to twice-daily oral-only dosing of linezolid was initiated in August 2016. This study completed enrollment in May 2017 and top-line data are expected in mid-July. The Company plans to submit its new drug application (NDA) in the U.S. as early as the first quarter of 2018 with an EMA submission later in 2018. In addition to its Phase 3 program for omadacycline, a Phase 1B study in uncomplicated urinary tract infections (UTI) was initiated in May 2016 and positive top-line PK proof-of-principle data was reported in November 2016. The Company plans to begin enrolling patients in a proof-of-concept Phase 2 study of omadacycline in acute pyelonephritis, the most common subset of complicated urinary tract infections, as early as December 2017. In October 2016, Paratek announced a research agreement with the U.S. Department of Defense to explore the utility of omadacycline against pathogenic agents causing infectious diseases of public health and biodefense importance including plague and anthrax. In April 2017, Paratek Bermuda Ltd., a wholly-owned subsidiary of the Company, and Zai Lab (Shanghai) Co., Ltd., entered into a License and Collaboration Agreement. Under the terms of the Agreement, the Company granted Zai an exclusive license to develop, manufacture, and commercialize omadacycline in the People’s Republic of China, Hong Kong, Macau and Taiwan, for all human therapeutic and preventative uses, other than biodefense. Paratek's second Phase 3 product candidate, sarecycline, is a well-tolerated, once-daily oral, narrow spectrum tetracycline-derived antibiotic with potent anti-inflammatory properties for the potential treatment of acne and rosacea in the community setting. Allergan owns the U.S. rights for the development and commercialization of sarecycline. Paratek retains all ex-U.S. rights. Allergan and Paratek reported positive results from two identical Phase 3 registration studies of sarecycline for the treatment of moderate to severe acne vulgaris in March 2017. Allergan has publicly announced plans to submit an NDA in the U.S. in the second half of 2017. Forward Looking Statements This press release contains forward-looking statements including statements related to our overall strategy, product candidates, clinical studies, prospects, potential and expected results, including statements about the timing of advancing omadacycline and otherwise preparing for clinical studies, the timing of enrollment in our clinical studies and our reporting of the results of such studies, the potential for omadacycline to serve as an empiric monotherapy treatment option for patients suffering from ABSSSI, CABP, UTI, and other bacterial infections when resistance is of concern, the prospect of omadacycline providing broad-spectrum activity, and our ability to obtain regulatory approval of omadacycline All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "believe," "expect," "well positioned," "look forward," "anticipated," "continued," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties.  We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements.  Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties.  These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2016, and our other filings with the Securities and Exchange Commission.  We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.


JERSEY CITY, N.J., May 24, 2017 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology company delivering innovative anti-infective therapies for difficult-to-treat and often life-threatening infections, today announced eight poster presentations at ASM Microbe 2017, June 1 through 5 in New Orleans, LA. All presentations will feature the company’s lead candidate, SCY-078, the first representative of a novel intravenous (IV) and oral triterpenoid antifungal family in Phase 2 clinical development for the treatment of several fungal infections, including invasive candidiasis, invasive apergillosis and vulvovaginal candidiasis infections. “Following an active ECCMID 2017, the large set of data to be presented further confirms the versatility of SCY-078 across treatment settings and against a wide array of Candida and Aspergillus fungal species,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “SCY-078’s compatibility in combination with other frequently used drugs and high tissue penetration into organ systems where infections occur are significant differentiators for this novel anti-infective. These presentations further support the potential broad applicability of SCY-078 and its ability to be a next-generation agent to fight these infections, including multi-drug-resistant pathogens such as Candida auris.” Further details on these presentations will be available on the SCYNEXIS website following the event. All abstracts are available on the ASM Microbe 2017 Online Program Planner. The details of the presentations are as follows: Title: Pharmacokinetics and Pharmacodynamics in Patients from a Phase 2, Multicenter, Open-Label, Randomized, Comparative Study of Oral SCY-078 vs. Standard-of-Care Following Initial Intravenous Echinocandin Therapy in the Treatment of Invasive Candidiasis (Including Candidemia) in Hospitalized Non-Neutropenic Adults Date and Time: Friday, June 2 from 12:45 – 2:45 p.m. CDT Location: Exhibit Hall D Poster Presentation #: 193 Session: Antimicrobial Pharmacokinetics: Antifungal PK/PD Studies Title: In Vitro Interaction between SCY-078, Echinocandins and Azoles against Susceptible and Resistant Candida spp. Determined by the Checkerboard Method Date and Time: Friday, June 2 from 12:45 – 2:45 p.m. CDT Location: Exhibit Hall D Poster Presentation #: 248 Session: Mycology: Clinical and Laboratory Studies of Antifungal Drug Resistance Title: CYP-Mediated Drug Interaction Profile of SCY-078, a Novel Triterpene Glucan Synthase Inhibitor (GSI) Date and Time: Saturday, June 3 from 12:15 – 2:15 p.m. CDT Location: Exhibit Hall D Poster Presentation #: 173 Session: Antimicrobial Stewardship and Quality of Care: Antibiotic Safety Title: Lack of an Effect of SCY-078, a Novel Antifungal Agent on QTc Interval in Healthy Subjects Date and Time: Saturday, June 3 from 12:15 – 2:15 p.m. CDT Location: Exhibit Hall D Poster Presentation #: 172 Session: Antimicrobial Stewardship and Quality of Care: Antibiotic Safety Title: Pharmacokinetics of SCY-078 Following Intravenous Administration in Rabbits: Implications for Treatment of Experimental Invasive Pulmonary Aspergillosis Date and Time: Saturday, June 3 from 12:15 – 2:15 p.m. CDT Location: Exhibit Hall D Poster Presentation #: 231 Session: Mycology: New Antifungal Agents I Title: Assessment of the In Vitro Antifungal Activity of SCY-078 against a Panel of Susceptible and Resistant, Clinical Candida Isolates from Europe Date and Time: Sunday, June 4 from 12:15 – 2:15 p.m. CDT Location: Exhibit Hall D Poster Presentation #: 308 Session: Mycology: New Antifungal Agents II Title: SCY-078, a Novel Intravenous and Oral Antifungal Agent, Demonstrates Extensive Tissue Distribution in Rats Following Single Intravenous Infusions and Oral Doses of [14C]SCY-078 Date and Time: Sunday, June 4 from 12:15 - 2:15 p.m. CDT Poster Presentation #: 309 Session: Mycology: New Antifungal Agents II Title: Susceptibility Testing of SCY‐078 against Candida Isolates Obtained from a Clinical Study of Oral SCY‐078 vs. Oral Fluconazole in Subjects with Moderate to Severe Vulvovaginal Candidiasis Demonstrates No Resistance Development Date and Time: Sunday, June 4 from 12:15 – 2:15 p.m. CDT Location: Exhibit Hall D Poster Presentation #: 307 Session: Mycology: New Antifungal Agents II About SCY-078 SCY-078 is an oral and IV antifungal agent in Phase 2 clinical development for the treatment of fungal infections caused by Candida and Aspergillus species. SCY-078 is a triterpenoid, semi-synthetic derivative of the natural product enfumafungin—a structurally distinct and novel class of glucan synthase inhibitor. SCY-078 combines the well-established activity of glucan synthase inhibitors (similar to echinocandins) with the potential flexibility of having IV and oral formulations (similar to azoles). By belonging to a chemical class distinct from other antifungals, SCY-078 has shown in vitro and in vivo activity against multi-drug resistant pathogens, including azole- and echinocandin-resistant strains. The U.S. Food and Drug Administration granted Fast Track, Qualified Infectious Disease Product and Orphan Drug Designations for the oral and IV formulations of SCY-078 for the indications of invasive candidiasis (including candidemia) and invasive aspergillosis. About Invasive Candidiasis Infections Invasive candidiasis is a serious, often life-threatening infection caused by Candida species that typically affects a highly vulnerable population such as immunocompromised patients or patients under intensive care in hospital settings.  The U.S. annual incidence is estimated to be approximately 100,000 cases with high mortality rates (i.e., 20-40%) despite currently available antifungal agents. Furthermore, the limited number of antifungal drug classes, consisting of azoles, echinocandins and polyenes, and their widespread use, has led to increased numbers of candida infections with drug-resistant strains. The CDC has listed fluconazole-resistant Candida as a serious public health threat requiring prompt and sustained action. About Invasive Aspergillus Infections Invasive aspergillosis is a serious fungal infection caused by Aspergillus species that usually affects people who have weakened immune systems, such as people who have had an organ transplant or a stem cell transplant. Invasive aspergillosis most commonly affects the lungs, but it can also spread to other parts of the body. There are approximately 50,000 cases of invasive aspergillosis reported in the U.S. annually, with a mortality rate as high as 50%. Current standard of treatment is eight to 12 weeks of azoles usually started as IV treatment for one to two weeks followed by oral step-down treatment for several weeks. About Vulvovaginal Candidiasis Infections Vulvovaginal candidiasis (VVC), commonly known as a "yeast infection," is usually caused by Candida albicans and typical symptoms include pruritus, vaginal soreness, irritation and abnormal vaginal discharge. An estimated 75% of women will have at least one episode of VVC during their lifetime and 40%-45% will experience two or more episodes. As many as 8% of these patients suffer from recurrent VVC, defined as experiencing at least four episodes a year. Current treatments for VVC include topical antifungals and the use of prescription oral antifungals such fluconazole, which has a therapeutic cure rate of 55% as reported in the label. There are no products currently approved for the treatment recurrent VVC. About SCYNEXIS, Inc. SCYNEXIS, Inc. is a biotechnology company committed to positively impacting the lives of patients suffering from difficult-to-treat and often life-threatening infections by delivering innovative anti-infective therapies. The SCYNEXIS team has extensive experience in the life sciences industry, discovering and developing more than 30 innovative medicines over a broad range of therapeutic areas. The Company's lead product candidate, SCY-078, is the first representative of a novel intravenous and oral triterpenoid antifungal family and is in Phase 2 clinical development for the treatment of several fungal infections, including serious and life-threatening invasive fungal infections.  For more information, visit www.scynexis.com. Forward Looking Statement Statements contained in this press release maybe, "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited, to: risks inherent in SCYNEXIS' ability to successfully develop SCY-078, including SCYNEXIS' ability to resolve the FDA's concerns to lift the clinical hold on the IV formulation of SCY-078 on a timely basis, if at all, and obtain FDA approval for SCY-078; the expected costs of studies and when they might begin or be concluded; and SCYNEXIS' reliance on third parties to conduct SCYNEXIS' clinical studies. These and other risks are described more fully in SCYNEXIS' filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K under the caption "Risk Factors" and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.


GEORGE TOWN, Cayman Islands--(BUSINESS WIRE)--Ironshore Pharmaceuticals & Development, Inc. (“Ironshore”), a wholly owned subsidiary of Highland Therapeutics Inc. and the global leader in the development of novel treatments for Attention-Deficit/Hyperactivity Disorder (“ADHD”), today announced that it will be presenting new Pivotal Trial Data for evening-dosed HLD200 (delayed-release and extended-release methylphenidate) at the American Psychiatric Association (“APA”) meeting, being held in San Diego through May 24, 2017. HLD200 is Ironshore’s investigational drug candidate for the treatment of ADHD; a New Drug Application is currently pending before the U.S. Food and Drug Administration (“FDA”). “We are delighted to be sharing Pivotal Trial Data for HLD200, which are being presented for the first time. It is a noteworthy finding that HLD200-treated children demonstrated statistically significant improvements, relative to placebo, in ADHD functioning during both the early morning and evening bedtime routines. These findings may correlate to the statistically significant reduction in measures of caregiver strain observed in the study data,” said Dr. Randy Sallee, Chief Medical Officer of Ironshore Pharmaceuticals Inc. “We know a child’s ADHD has an impact on the entire family unit, with parents experiencing much of the burden associated with their child’s inability to complete routine tasks during the morning and evening routine like brushing teeth, getting dressed, staying on schedule, sitting through meals and getting ready for bed. These tasks can be difficult for all young children, but they are exacerbated in patients with ADHD. If approved by the FDA, HLD200 could potentially change the way ADHD is treated given the observed impact on clinical outcomes.” Details of Ironshore’s poster sessions are below: Efficacy of HLD200 on Early Morning and Late Afternoon/Evening Functioning Assessed by Individual Item Ratings on the PREMB-R in Children With ADHD This post-hoc analysis of data from Ironshore’s pivotal study was conducted to further evaluate the efficacy of HLD200 versus placebo in reducing specific at-home functional impairments in children with ADHD by examining individual item ratings on the Parent Rating of Evening and Morning Behavior-Revised (“PREMB-R”) AM and PM subscales. After three weeks of treatment, HLD200 significantly improved all PREMB-R AM item scores, and four of the PREMB-R PM item scores, including “settling down and getting ready for bed” and “falling asleep”. These findings suggest that HLD200 consistently improves at-home functional impairment in children with ADHD from the early morning and lasting through the evening. Consistent Efficacy of HLD200 on Early Morning Functioning in Children With ADHD: Analysis of BSFQ Item Ratings This post-hoc analysis of data from HLD200’s pivotal study was conducted to further evaluate the efficacy of HLD200 versus placebo in reducing specific at-home early morning functioning (“EMF”) impairments in children with ADHD by examining individual item ratings on the Before School Functioning Questionnaire (“BSFQ”). In addition to improving overall EMF impairment in children with ADHD, HLD200 demonstrated consistent efficacy by significantly improving 19 out of 20 individual BSFQ item scores versus placebo. These findings suggest that HLD200 improves functioning across commonly reported areas of dysfunction associated with ADHD in children during early morning, before-school activities. Effect of HLD200 on Caregiver-Reported ADHD Symptom Improvement in Children With ADHD and Caregiver Strain: Results from a Phase 3 Trial This poster examines HLD200’s efficacy, versus placebo, in children with ADHD based on improvements in caregiver-rated ADHD symptoms, as measured by the Conners’ Global Index – Parent (“CGI-P”), and reductions in caregiver strain, as measured by the Caregiver Strain Questionnaire (“CGSQ”), versus placebo. After three weeks of treatment, caregivers reported statistically significant improvements in their child’s ADHD symptoms and these improvements coincided with reductions in caregiver strain (p<0.001 on the CGI-P and p=0.001 on the CGSQ). Single-Dose Pharmacokinetics of HLD200, a Delayed-Release and Extended-Release Methylphenidate, in Adults and in Adolescents and Children With ADHD HLD200 was well tolerated and demonstrated low intersubject variability in mean time to achieve ascending plasma concentrations, suggesting that HLD200 is consistent and predictable in the timing of methylphenidate release. After accounting for differences in body weight, the pharmacokinetics of HLD200 were similar between adults, and adolescents and children with ADHD, and their pharmacokinetic profiles appeared to be monophasic and nearly superimposable. Ironshore Pharmaceuticals & Development, Inc., a wholly owned subsidiary of Highland Therapeutics Inc., is a pharmaceutical company that is leveraging its proprietary technology, DELEXIS®, to optimize the delivery of previously approved drug products. Highland Therapeutics Inc. is a client of MaRS Discovery District’s Health Venture Services group, which provides advisory services, connections to talent, customer & capital networks, and market intelligence to high-impact, Ontario-based life sciences ventures, helping them commercialize their ideas and build globally competitive companies. This press release contains forward-looking information, which reflects Ironshore’s current expectations regarding future events. Forward-looking information is based on a number of assumptions and is subject to a number of risks and uncertainties, many of which are beyond Ironshore’s control that could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking information. These forward-looking statements are made as of the date of this press release and, except as expressly required by applicable law, Ironshore assumes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.


BOSTON, May 24, 2017 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today that data from its omadacycline clinical and microbiology programs will be presented at ASM Microbe 2017, to be held June 1 – 5 in New Orleans. Paratek is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry. “As we advance our clinical program, we continue to be encouraged by the study outcomes that add to our breadth of knowledge about the safety and efficacy of once-daily oral and IV omadacycline in the treatment of bacterial infections,” said Evan Loh, M.D., President, Chief Operating Officer, and Chief Medical Officer, Paratek. “Results from the 10 studies being presented at ASM Microbe include new phase 1 data examining omadacycline in patients with uncomplicated urinary tract infection as well as additional analyses of microbiology date that help further our understanding of how omadacycline may be used in a clinical setting. We continue to be excited about the potential for this compound to treat severe bacterial infections, particularly when resistance is of concern.” Paratek Presentations on Friday, June 2, 2017 at 12:45 p.m. – 2:45 p.m. CDT (1:45 p.m. – 3:45 p.m. EDT) Poster Session 45: Infection Prevention and Control: Skin, Soft Tissue and Bone Infections Paratek Presentations on Saturday, June 3, 2017 at 12:15 p.m. – 2:15 p.m. CDT (1:15 p.m. – 3:15 p.m. EDT) Poster Session 185: Antibacterial Resistance: In vitro Activity and Resistance to Tigecyline, Fosfomycin and Derivatives Paratek Presentations Sunday, June 4, 2017 at 12:15 p.m. – 2:15 p.m. CDT (1:15 p.m. – 3:15 p.m. EDT) Poster Session 341: Antimicrobial Pharmacokinetics: PK/PD of New Antimicrobial Agents Poster Session 345: Clostridium difficile: Epidemiology and Strategies for Prevention and Treatment of CD Infections About Paratek Pharmaceuticals, Inc. Paratek Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry. Paratek's lead product candidate, omadacycline, when approved, will be the first in a new class of tetracyclines known as aminomethylcyclines, with broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria. Omadacycline is a new, once-daily oral and intravenous broad spectrum antibiotic being developed for use as empiric monotherapy for patients suffering from serious community-acquired bacterial infections, such as acute bacterial skin and skin structure infections, community-acquired bacterial pneumonia, urinary tract infections, and other community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians. Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration for the target indications. In June 2016, Paratek announced positive efficacy data in a Phase 3 registration study in acute bacterial skin and skin structure infections (ABSSSI) demonstrating the efficacy and general safety and tolerability of intravenous (IV) to once-daily oral omadacycline compared to linezolid. In April 2017, Paratek announced positive efficacy data in a Phase 3 registration study in community-acquired bacterial pneumonia (CABP) demonstrating the efficacy and general safety and tolerability of IV to once-daily oral omadacycline compared to moxifloxacin. A Phase 3 registration study in ABSSSI comparing once-daily oral-only dosing of omadacycline to twice-daily oral-only dosing of linezolid was initiated in August 2016. This study completed enrollment in May 2017 and top-line data are expected in mid-July. The Company plans to submit its new drug application (NDA) in the U.S. as early as the first quarter of 2018 with an EMA submission later in 2018. In addition to its Phase 3 program for omadacycline, a Phase 1B study in uncomplicated urinary tract infections (UTI) was initiated in May 2016 and positive top-line PK proof-of-principle data was reported in November 2016. The Company plans to begin enrolling patients in a proof-of-concept Phase 2 study of omadacycline in acute pyelonephritis, the most common subset of complicated urinary tract infections, as early as December 2017. In October 2016, Paratek announced a research agreement with the U.S. Department of Defense to explore the utility of omadacycline against pathogenic agents causing infectious diseases of public health and biodefense importance including plague and anthrax. In April 2017, Paratek Bermuda Ltd., a wholly-owned subsidiary of the Company, and Zai Lab (Shanghai) Co., Ltd., entered into a License and Collaboration Agreement. Under the terms of the Agreement, the Company granted Zai an exclusive license to develop, manufacture, and commercialize omadacycline in the People’s Republic of China, Hong Kong, Macau and Taiwan, for all human therapeutic and preventative uses, other than biodefense. Paratek's second Phase 3 product candidate, sarecycline, is a well-tolerated, once-daily oral, narrow spectrum tetracycline-derived antibiotic with potent anti-inflammatory properties for the potential treatment of acne and rosacea in the community setting. Allergan owns the U.S. rights for the development and commercialization of sarecycline. Paratek retains all ex-U.S. rights. Allergan and Paratek reported positive results from two identical Phase 3 registration studies of sarecycline for the treatment of moderate to severe acne vulgaris in March 2017. Allergan has publicly announced plans to submit an NDA in the U.S. in the second half of 2017. Forward Looking Statements This press release contains forward-looking statements including statements related to our overall strategy, product candidates, clinical studies, prospects, potential and expected results, including statements about the timing of advancing omadacycline and otherwise preparing for clinical studies, the timing of enrollment in our clinical studies and our reporting of the results of such studies, the potential for omadacycline to serve as an empiric monotherapy treatment option for patients suffering from ABSSSI, CABP, UTI, and other bacterial infections when resistance is of concern, the prospect of omadacycline providing broad-spectrum activity, and our ability to obtain regulatory approval of omadacycline All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "believe," "expect," "well positioned," "look forward," "anticipated," "continued," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties.  We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements.  Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties.  These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2016, and our other filings with the Securities and Exchange Commission.  We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.


JERSEY CITY, N.J., May 24, 2017 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology company delivering innovative anti-infective therapies for difficult-to-treat and often life-threatening infections, today announced eight poster presentations at ASM Microbe 2017, June 1 through 5 in New Orleans, LA. All presentations will feature the company’s lead candidate, SCY-078, the first representative of a novel intravenous (IV) and oral triterpenoid antifungal family in Phase 2 clinical development for the treatment of several fungal infections, including invasive candidiasis, invasive apergillosis and vulvovaginal candidiasis infections. “Following an active ECCMID 2017, the large set of data to be presented further confirms the versatility of SCY-078 across treatment settings and against a wide array of Candida and Aspergillus fungal species,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “SCY-078’s compatibility in combination with other frequently used drugs and high tissue penetration into organ systems where infections occur are significant differentiators for this novel anti-infective. These presentations further support the potential broad applicability of SCY-078 and its ability to be a next-generation agent to fight these infections, including multi-drug-resistant pathogens such as Candida auris.” Further details on these presentations will be available on the SCYNEXIS website following the event. All abstracts are available on the ASM Microbe 2017 Online Program Planner. The details of the presentations are as follows: Title: Pharmacokinetics and Pharmacodynamics in Patients from a Phase 2, Multicenter, Open-Label, Randomized, Comparative Study of Oral SCY-078 vs. Standard-of-Care Following Initial Intravenous Echinocandin Therapy in the Treatment of Invasive Candidiasis (Including Candidemia) in Hospitalized Non-Neutropenic Adults Date and Time: Friday, June 2 from 12:45 – 2:45 p.m. CDT Location: Exhibit Hall D Poster Presentation #: 193 Session: Antimicrobial Pharmacokinetics: Antifungal PK/PD Studies Title: In Vitro Interaction between SCY-078, Echinocandins and Azoles against Susceptible and Resistant Candida spp. Determined by the Checkerboard Method Date and Time: Friday, June 2 from 12:45 – 2:45 p.m. CDT Location: Exhibit Hall D Poster Presentation #: 248 Session: Mycology: Clinical and Laboratory Studies of Antifungal Drug Resistance Title: CYP-Mediated Drug Interaction Profile of SCY-078, a Novel Triterpene Glucan Synthase Inhibitor (GSI) Date and Time: Saturday, June 3 from 12:15 – 2:15 p.m. CDT Location: Exhibit Hall D Poster Presentation #: 173 Session: Antimicrobial Stewardship and Quality of Care: Antibiotic Safety Title: Lack of an Effect of SCY-078, a Novel Antifungal Agent on QTc Interval in Healthy Subjects Date and Time: Saturday, June 3 from 12:15 – 2:15 p.m. CDT Location: Exhibit Hall D Poster Presentation #: 172 Session: Antimicrobial Stewardship and Quality of Care: Antibiotic Safety Title: Pharmacokinetics of SCY-078 Following Intravenous Administration in Rabbits: Implications for Treatment of Experimental Invasive Pulmonary Aspergillosis Date and Time: Saturday, June 3 from 12:15 – 2:15 p.m. CDT Location: Exhibit Hall D Poster Presentation #: 231 Session: Mycology: New Antifungal Agents I Title: Assessment of the In Vitro Antifungal Activity of SCY-078 against a Panel of Susceptible and Resistant, Clinical Candida Isolates from Europe Date and Time: Sunday, June 4 from 12:15 – 2:15 p.m. CDT Location: Exhibit Hall D Poster Presentation #: 308 Session: Mycology: New Antifungal Agents II Title: SCY-078, a Novel Intravenous and Oral Antifungal Agent, Demonstrates Extensive Tissue Distribution in Rats Following Single Intravenous Infusions and Oral Doses of [14C]SCY-078 Date and Time: Sunday, June 4 from 12:15 - 2:15 p.m. CDT Poster Presentation #: 309 Session: Mycology: New Antifungal Agents II Title: Susceptibility Testing of SCY‐078 against Candida Isolates Obtained from a Clinical Study of Oral SCY‐078 vs. Oral Fluconazole in Subjects with Moderate to Severe Vulvovaginal Candidiasis Demonstrates No Resistance Development Date and Time: Sunday, June 4 from 12:15 – 2:15 p.m. CDT Location: Exhibit Hall D Poster Presentation #: 307 Session: Mycology: New Antifungal Agents II About SCY-078 SCY-078 is an oral and IV antifungal agent in Phase 2 clinical development for the treatment of fungal infections caused by Candida and Aspergillus species. SCY-078 is a triterpenoid, semi-synthetic derivative of the natural product enfumafungin—a structurally distinct and novel class of glucan synthase inhibitor. SCY-078 combines the well-established activity of glucan synthase inhibitors (similar to echinocandins) with the potential flexibility of having IV and oral formulations (similar to azoles). By belonging to a chemical class distinct from other antifungals, SCY-078 has shown in vitro and in vivo activity against multi-drug resistant pathogens, including azole- and echinocandin-resistant strains. The U.S. Food and Drug Administration granted Fast Track, Qualified Infectious Disease Product and Orphan Drug Designations for the oral and IV formulations of SCY-078 for the indications of invasive candidiasis (including candidemia) and invasive aspergillosis. About Invasive Candidiasis Infections Invasive candidiasis is a serious, often life-threatening infection caused by Candida species that typically affects a highly vulnerable population such as immunocompromised patients or patients under intensive care in hospital settings.  The U.S. annual incidence is estimated to be approximately 100,000 cases with high mortality rates (i.e., 20-40%) despite currently available antifungal agents. Furthermore, the limited number of antifungal drug classes, consisting of azoles, echinocandins and polyenes, and their widespread use, has led to increased numbers of candida infections with drug-resistant strains. The CDC has listed fluconazole-resistant Candida as a serious public health threat requiring prompt and sustained action. About Invasive Aspergillus Infections Invasive aspergillosis is a serious fungal infection caused by Aspergillus species that usually affects people who have weakened immune systems, such as people who have had an organ transplant or a stem cell transplant. Invasive aspergillosis most commonly affects the lungs, but it can also spread to other parts of the body. There are approximately 50,000 cases of invasive aspergillosis reported in the U.S. annually, with a mortality rate as high as 50%. Current standard of treatment is eight to 12 weeks of azoles usually started as IV treatment for one to two weeks followed by oral step-down treatment for several weeks. About Vulvovaginal Candidiasis Infections Vulvovaginal candidiasis (VVC), commonly known as a "yeast infection," is usually caused by Candida albicans and typical symptoms include pruritus, vaginal soreness, irritation and abnormal vaginal discharge. An estimated 75% of women will have at least one episode of VVC during their lifetime and 40%-45% will experience two or more episodes. As many as 8% of these patients suffer from recurrent VVC, defined as experiencing at least four episodes a year. Current treatments for VVC include topical antifungals and the use of prescription oral antifungals such fluconazole, which has a therapeutic cure rate of 55% as reported in the label. There are no products currently approved for the treatment recurrent VVC. About SCYNEXIS, Inc. SCYNEXIS, Inc. is a biotechnology company committed to positively impacting the lives of patients suffering from difficult-to-treat and often life-threatening infections by delivering innovative anti-infective therapies. The SCYNEXIS team has extensive experience in the life sciences industry, discovering and developing more than 30 innovative medicines over a broad range of therapeutic areas. The Company's lead product candidate, SCY-078, is the first representative of a novel intravenous and oral triterpenoid antifungal family and is in Phase 2 clinical development for the treatment of several fungal infections, including serious and life-threatening invasive fungal infections.  For more information, visit www.scynexis.com. Forward Looking Statement Statements contained in this press release maybe, "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited, to: risks inherent in SCYNEXIS' ability to successfully develop SCY-078, including SCYNEXIS' ability to resolve the FDA's concerns to lift the clinical hold on the IV formulation of SCY-078 on a timely basis, if at all, and obtain FDA approval for SCY-078; the expected costs of studies and when they might begin or be concluded; and SCYNEXIS' reliance on third parties to conduct SCYNEXIS' clinical studies. These and other risks are described more fully in SCYNEXIS' filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K under the caption "Risk Factors" and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.


BOSTON, May 24, 2017 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today that data from its omadacycline clinical and microbiology programs will be presented at ASM Microbe 2017, to be held June 1 – 5 in New Orleans. Paratek is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry. “As we advance our clinical program, we continue to be encouraged by the study outcomes that add to our breadth of knowledge about the safety and efficacy of once-daily oral and IV omadacycline in the treatment of bacterial infections,” said Evan Loh, M.D., President, Chief Operating Officer, and Chief Medical Officer, Paratek. “Results from the 10 studies being presented at ASM Microbe include new phase 1 data examining omadacycline in patients with uncomplicated urinary tract infection as well as additional analyses of microbiology date that help further our understanding of how omadacycline may be used in a clinical setting. We continue to be excited about the potential for this compound to treat severe bacterial infections, particularly when resistance is of concern.” Paratek Presentations on Friday, June 2, 2017 at 12:45 p.m. – 2:45 p.m. CDT (1:45 p.m. – 3:45 p.m. EDT) Poster Session 45: Infection Prevention and Control: Skin, Soft Tissue and Bone Infections Paratek Presentations on Saturday, June 3, 2017 at 12:15 p.m. – 2:15 p.m. CDT (1:15 p.m. – 3:15 p.m. EDT) Poster Session 185: Antibacterial Resistance: In vitro Activity and Resistance to Tigecyline, Fosfomycin and Derivatives Paratek Presentations Sunday, June 4, 2017 at 12:15 p.m. – 2:15 p.m. CDT (1:15 p.m. – 3:15 p.m. EDT) Poster Session 341: Antimicrobial Pharmacokinetics: PK/PD of New Antimicrobial Agents Poster Session 345: Clostridium difficile: Epidemiology and Strategies for Prevention and Treatment of CD Infections About Paratek Pharmaceuticals, Inc. Paratek Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry. Paratek's lead product candidate, omadacycline, when approved, will be the first in a new class of tetracyclines known as aminomethylcyclines, with broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria. Omadacycline is a new, once-daily oral and intravenous broad spectrum antibiotic being developed for use as empiric monotherapy for patients suffering from serious community-acquired bacterial infections, such as acute bacterial skin and skin structure infections, community-acquired bacterial pneumonia, urinary tract infections, and other community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians. Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration for the target indications. In June 2016, Paratek announced positive efficacy data in a Phase 3 registration study in acute bacterial skin and skin structure infections (ABSSSI) demonstrating the efficacy and general safety and tolerability of intravenous (IV) to once-daily oral omadacycline compared to linezolid. In April 2017, Paratek announced positive efficacy data in a Phase 3 registration study in community-acquired bacterial pneumonia (CABP) demonstrating the efficacy and general safety and tolerability of IV to once-daily oral omadacycline compared to moxifloxacin. A Phase 3 registration study in ABSSSI comparing once-daily oral-only dosing of omadacycline to twice-daily oral-only dosing of linezolid was initiated in August 2016. This study completed enrollment in May 2017 and top-line data are expected in mid-July. The Company plans to submit its new drug application (NDA) in the U.S. as early as the first quarter of 2018 with an EMA submission later in 2018. In addition to its Phase 3 program for omadacycline, a Phase 1B study in uncomplicated urinary tract infections (UTI) was initiated in May 2016 and positive top-line PK proof-of-principle data was reported in November 2016. The Company plans to begin enrolling patients in a proof-of-concept Phase 2 study of omadacycline in acute pyelonephritis, the most common subset of complicated urinary tract infections, as early as December 2017. In October 2016, Paratek announced a research agreement with the U.S. Department of Defense to explore the utility of omadacycline against pathogenic agents causing infectious diseases of public health and biodefense importance including plague and anthrax. In April 2017, Paratek Bermuda Ltd., a wholly-owned subsidiary of the Company, and Zai Lab (Shanghai) Co., Ltd., entered into a License and Collaboration Agreement. Under the terms of the Agreement, the Company granted Zai an exclusive license to develop, manufacture, and commercialize omadacycline in the People’s Republic of China, Hong Kong, Macau and Taiwan, for all human therapeutic and preventative uses, other than biodefense. Paratek's second Phase 3 product candidate, sarecycline, is a well-tolerated, once-daily oral, narrow spectrum tetracycline-derived antibiotic with potent anti-inflammatory properties for the potential treatment of acne and rosacea in the community setting. Allergan owns the U.S. rights for the development and commercialization of sarecycline. Paratek retains all ex-U.S. rights. Allergan and Paratek reported positive results from two identical Phase 3 registration studies of sarecycline for the treatment of moderate to severe acne vulgaris in March 2017. Allergan has publicly announced plans to submit an NDA in the U.S. in the second half of 2017. Forward Looking Statements This press release contains forward-looking statements including statements related to our overall strategy, product candidates, clinical studies, prospects, potential and expected results, including statements about the timing of advancing omadacycline and otherwise preparing for clinical studies, the timing of enrollment in our clinical studies and our reporting of the results of such studies, the potential for omadacycline to serve as an empiric monotherapy treatment option for patients suffering from ABSSSI, CABP, UTI, and other bacterial infections when resistance is of concern, the prospect of omadacycline providing broad-spectrum activity, and our ability to obtain regulatory approval of omadacycline All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "believe," "expect," "well positioned," "look forward," "anticipated," "continued," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties.  We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements.  Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties.  These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2016, and our other filings with the Securities and Exchange Commission.  We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.


JERSEY CITY, N.J., May 24, 2017 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology company delivering innovative anti-infective therapies for difficult-to-treat and often life-threatening infections, today announced eight poster presentations at ASM Microbe 2017, June 1 through 5 in New Orleans, LA. All presentations will feature the company’s lead candidate, SCY-078, the first representative of a novel intravenous (IV) and oral triterpenoid antifungal family in Phase 2 clinical development for the treatment of several fungal infections, including invasive candidiasis, invasive apergillosis and vulvovaginal candidiasis infections. “Following an active ECCMID 2017, the large set of data to be presented further confirms the versatility of SCY-078 across treatment settings and against a wide array of Candida and Aspergillus fungal species,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “SCY-078’s compatibility in combination with other frequently used drugs and high tissue penetration into organ systems where infections occur are significant differentiators for this novel anti-infective. These presentations further support the potential broad applicability of SCY-078 and its ability to be a next-generation agent to fight these infections, including multi-drug-resistant pathogens such as Candida auris.” Further details on these presentations will be available on the SCYNEXIS website following the event. All abstracts are available on the ASM Microbe 2017 Online Program Planner. The details of the presentations are as follows: Title: Pharmacokinetics and Pharmacodynamics in Patients from a Phase 2, Multicenter, Open-Label, Randomized, Comparative Study of Oral SCY-078 vs. Standard-of-Care Following Initial Intravenous Echinocandin Therapy in the Treatment of Invasive Candidiasis (Including Candidemia) in Hospitalized Non-Neutropenic Adults Date and Time: Friday, June 2 from 12:45 – 2:45 p.m. CDT Location: Exhibit Hall D Poster Presentation #: 193 Session: Antimicrobial Pharmacokinetics: Antifungal PK/PD Studies Title: In Vitro Interaction between SCY-078, Echinocandins and Azoles against Susceptible and Resistant Candida spp. Determined by the Checkerboard Method Date and Time: Friday, June 2 from 12:45 – 2:45 p.m. CDT Location: Exhibit Hall D Poster Presentation #: 248 Session: Mycology: Clinical and Laboratory Studies of Antifungal Drug Resistance Title: CYP-Mediated Drug Interaction Profile of SCY-078, a Novel Triterpene Glucan Synthase Inhibitor (GSI) Date and Time: Saturday, June 3 from 12:15 – 2:15 p.m. CDT Location: Exhibit Hall D Poster Presentation #: 173 Session: Antimicrobial Stewardship and Quality of Care: Antibiotic Safety Title: Lack of an Effect of SCY-078, a Novel Antifungal Agent on QTc Interval in Healthy Subjects Date and Time: Saturday, June 3 from 12:15 – 2:15 p.m. CDT Location: Exhibit Hall D Poster Presentation #: 172 Session: Antimicrobial Stewardship and Quality of Care: Antibiotic Safety Title: Pharmacokinetics of SCY-078 Following Intravenous Administration in Rabbits: Implications for Treatment of Experimental Invasive Pulmonary Aspergillosis Date and Time: Saturday, June 3 from 12:15 – 2:15 p.m. CDT Location: Exhibit Hall D Poster Presentation #: 231 Session: Mycology: New Antifungal Agents I Title: Assessment of the In Vitro Antifungal Activity of SCY-078 against a Panel of Susceptible and Resistant, Clinical Candida Isolates from Europe Date and Time: Sunday, June 4 from 12:15 – 2:15 p.m. CDT Location: Exhibit Hall D Poster Presentation #: 308 Session: Mycology: New Antifungal Agents II Title: SCY-078, a Novel Intravenous and Oral Antifungal Agent, Demonstrates Extensive Tissue Distribution in Rats Following Single Intravenous Infusions and Oral Doses of [14C]SCY-078 Date and Time: Sunday, June 4 from 12:15 - 2:15 p.m. CDT Poster Presentation #: 309 Session: Mycology: New Antifungal Agents II Title: Susceptibility Testing of SCY‐078 against Candida Isolates Obtained from a Clinical Study of Oral SCY‐078 vs. Oral Fluconazole in Subjects with Moderate to Severe Vulvovaginal Candidiasis Demonstrates No Resistance Development Date and Time: Sunday, June 4 from 12:15 – 2:15 p.m. CDT Location: Exhibit Hall D Poster Presentation #: 307 Session: Mycology: New Antifungal Agents II About SCY-078 SCY-078 is an oral and IV antifungal agent in Phase 2 clinical development for the treatment of fungal infections caused by Candida and Aspergillus species. SCY-078 is a triterpenoid, semi-synthetic derivative of the natural product enfumafungin—a structurally distinct and novel class of glucan synthase inhibitor. SCY-078 combines the well-established activity of glucan synthase inhibitors (similar to echinocandins) with the potential flexibility of having IV and oral formulations (similar to azoles). By belonging to a chemical class distinct from other antifungals, SCY-078 has shown in vitro and in vivo activity against multi-drug resistant pathogens, including azole- and echinocandin-resistant strains. The U.S. Food and Drug Administration granted Fast Track, Qualified Infectious Disease Product and Orphan Drug Designations for the oral and IV formulations of SCY-078 for the indications of invasive candidiasis (including candidemia) and invasive aspergillosis. About Invasive Candidiasis Infections Invasive candidiasis is a serious, often life-threatening infection caused by Candida species that typically affects a highly vulnerable population such as immunocompromised patients or patients under intensive care in hospital settings.  The U.S. annual incidence is estimated to be approximately 100,000 cases with high mortality rates (i.e., 20-40%) despite currently available antifungal agents. Furthermore, the limited number of antifungal drug classes, consisting of azoles, echinocandins and polyenes, and their widespread use, has led to increased numbers of candida infections with drug-resistant strains. The CDC has listed fluconazole-resistant Candida as a serious public health threat requiring prompt and sustained action. About Invasive Aspergillus Infections Invasive aspergillosis is a serious fungal infection caused by Aspergillus species that usually affects people who have weakened immune systems, such as people who have had an organ transplant or a stem cell transplant. Invasive aspergillosis most commonly affects the lungs, but it can also spread to other parts of the body. There are approximately 50,000 cases of invasive aspergillosis reported in the U.S. annually, with a mortality rate as high as 50%. Current standard of treatment is eight to 12 weeks of azoles usually started as IV treatment for one to two weeks followed by oral step-down treatment for several weeks. About Vulvovaginal Candidiasis Infections Vulvovaginal candidiasis (VVC), commonly known as a "yeast infection," is usually caused by Candida albicans and typical symptoms include pruritus, vaginal soreness, irritation and abnormal vaginal discharge. An estimated 75% of women will have at least one episode of VVC during their lifetime and 40%-45% will experience two or more episodes. As many as 8% of these patients suffer from recurrent VVC, defined as experiencing at least four episodes a year. Current treatments for VVC include topical antifungals and the use of prescription oral antifungals such fluconazole, which has a therapeutic cure rate of 55% as reported in the label. There are no products currently approved for the treatment recurrent VVC. About SCYNEXIS, Inc. SCYNEXIS, Inc. is a biotechnology company committed to positively impacting the lives of patients suffering from difficult-to-treat and often life-threatening infections by delivering innovative anti-infective therapies. The SCYNEXIS team has extensive experience in the life sciences industry, discovering and developing more than 30 innovative medicines over a broad range of therapeutic areas. The Company's lead product candidate, SCY-078, is the first representative of a novel intravenous and oral triterpenoid antifungal family and is in Phase 2 clinical development for the treatment of several fungal infections, including serious and life-threatening invasive fungal infections.  For more information, visit www.scynexis.com. Forward Looking Statement Statements contained in this press release maybe, "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited, to: risks inherent in SCYNEXIS' ability to successfully develop SCY-078, including SCYNEXIS' ability to resolve the FDA's concerns to lift the clinical hold on the IV formulation of SCY-078 on a timely basis, if at all, and obtain FDA approval for SCY-078; the expected costs of studies and when they might begin or be concluded; and SCYNEXIS' reliance on third parties to conduct SCYNEXIS' clinical studies. These and other risks are described more fully in SCYNEXIS' filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K under the caption "Risk Factors" and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.


BOSTON, May 24, 2017 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today that data from its omadacycline clinical and microbiology programs will be presented at ASM Microbe 2017, to be held June 1 – 5 in New Orleans. Paratek is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry. “As we advance our clinical program, we continue to be encouraged by the study outcomes that add to our breadth of knowledge about the safety and efficacy of once-daily oral and IV omadacycline in the treatment of bacterial infections,” said Evan Loh, M.D., President, Chief Operating Officer, and Chief Medical Officer, Paratek. “Results from the 10 studies being presented at ASM Microbe include new phase 1 data examining omadacycline in patients with uncomplicated urinary tract infection as well as additional analyses of microbiology date that help further our understanding of how omadacycline may be used in a clinical setting. We continue to be excited about the potential for this compound to treat severe bacterial infections, particularly when resistance is of concern.” Paratek Presentations on Friday, June 2, 2017 at 12:45 p.m. – 2:45 p.m. CDT (1:45 p.m. – 3:45 p.m. EDT) Poster Session 45: Infection Prevention and Control: Skin, Soft Tissue and Bone Infections Paratek Presentations on Saturday, June 3, 2017 at 12:15 p.m. – 2:15 p.m. CDT (1:15 p.m. – 3:15 p.m. EDT) Poster Session 185: Antibacterial Resistance: In vitro Activity and Resistance to Tigecyline, Fosfomycin and Derivatives Paratek Presentations Sunday, June 4, 2017 at 12:15 p.m. – 2:15 p.m. CDT (1:15 p.m. – 3:15 p.m. EDT) Poster Session 341: Antimicrobial Pharmacokinetics: PK/PD of New Antimicrobial Agents Poster Session 345: Clostridium difficile: Epidemiology and Strategies for Prevention and Treatment of CD Infections About Paratek Pharmaceuticals, Inc. Paratek Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry. Paratek's lead product candidate, omadacycline, when approved, will be the first in a new class of tetracyclines known as aminomethylcyclines, with broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria. Omadacycline is a new, once-daily oral and intravenous broad spectrum antibiotic being developed for use as empiric monotherapy for patients suffering from serious community-acquired bacterial infections, such as acute bacterial skin and skin structure infections, community-acquired bacterial pneumonia, urinary tract infections, and other community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians. Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration for the target indications. In June 2016, Paratek announced positive efficacy data in a Phase 3 registration study in acute bacterial skin and skin structure infections (ABSSSI) demonstrating the efficacy and general safety and tolerability of intravenous (IV) to once-daily oral omadacycline compared to linezolid. In April 2017, Paratek announced positive efficacy data in a Phase 3 registration study in community-acquired bacterial pneumonia (CABP) demonstrating the efficacy and general safety and tolerability of IV to once-daily oral omadacycline compared to moxifloxacin. A Phase 3 registration study in ABSSSI comparing once-daily oral-only dosing of omadacycline to twice-daily oral-only dosing of linezolid was initiated in August 2016. This study completed enrollment in May 2017 and top-line data are expected in mid-July. The Company plans to submit its new drug application (NDA) in the U.S. as early as the first quarter of 2018 with an EMA submission later in 2018. In addition to its Phase 3 program for omadacycline, a Phase 1B study in uncomplicated urinary tract infections (UTI) was initiated in May 2016 and positive top-line PK proof-of-principle data was reported in November 2016. The Company plans to begin enrolling patients in a proof-of-concept Phase 2 study of omadacycline in acute pyelonephritis, the most common subset of complicated urinary tract infections, as early as December 2017. In October 2016, Paratek announced a research agreement with the U.S. Department of Defense to explore the utility of omadacycline against pathogenic agents causing infectious diseases of public health and biodefense importance including plague and anthrax. In April 2017, Paratek Bermuda Ltd., a wholly-owned subsidiary of the Company, and Zai Lab (Shanghai) Co., Ltd., entered into a License and Collaboration Agreement. Under the terms of the Agreement, the Company granted Zai an exclusive license to develop, manufacture, and commercialize omadacycline in the People’s Republic of China, Hong Kong, Macau and Taiwan, for all human therapeutic and preventative uses, other than biodefense. Paratek's second Phase 3 product candidate, sarecycline, is a well-tolerated, once-daily oral, narrow spectrum tetracycline-derived antibiotic with potent anti-inflammatory properties for the potential treatment of acne and rosacea in the community setting. Allergan owns the U.S. rights for the development and commercialization of sarecycline. Paratek retains all ex-U.S. rights. Allergan and Paratek reported positive results from two identical Phase 3 registration studies of sarecycline for the treatment of moderate to severe acne vulgaris in March 2017. Allergan has publicly announced plans to submit an NDA in the U.S. in the second half of 2017. Forward Looking Statements This press release contains forward-looking statements including statements related to our overall strategy, product candidates, clinical studies, prospects, potential and expected results, including statements about the timing of advancing omadacycline and otherwise preparing for clinical studies, the timing of enrollment in our clinical studies and our reporting of the results of such studies, the potential for omadacycline to serve as an empiric monotherapy treatment option for patients suffering from ABSSSI, CABP, UTI, and other bacterial infections when resistance is of concern, the prospect of omadacycline providing broad-spectrum activity, and our ability to obtain regulatory approval of omadacycline All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "believe," "expect," "well positioned," "look forward," "anticipated," "continued," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties.  We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements.  Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties.  These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2016, and our other filings with the Securities and Exchange Commission.  We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

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