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WESTMINSTER, Colo., May 15, 2017 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (Nasdaq:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, today reported financial results for the quarter ended March 31, 2017, and provided a business update. A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740 “We’ve made great progress so far this year, recently achieving enrollment of the 200th patient in the GENETIC-AF clinical trial. The strategies we’ve implemented have increased the rate of patient enrollment. We’d like to thank the investigators and the study patients, whose support and enthusiasm suggests a high unmet medical need for this patient population and potentially a substantial market opportunity if Gencaro is approved,” commented Dr. Michael Bristow, ARCA’s President and Chief Executive Officer. “We are focused on the upcoming DSMB interim efficacy analysis that will determine the next steps for this adaptive, seamless design trial – transitioning to Phase 3 and enrolling an additional 370 patients; completing Phase 2B with 250 patients; or, stopping immediately for futility.  We expect the outcome of this interim efficacy analysis in September 2017.” Dr. Bristow further commented, “Atrial fibrillation is considered an epidemic cardiovascular disease based on the pace of increase in incidence in the United States and industrialized countries. There is also increasing evidence that compared to heart failure with sinus rhythm, heart failure with atrial fibrillation responds differently to medical therapy and needs to be approached as a separate disorder. We believe that a precision medicine approach to drug development in atrial fibrillation-heart failure, tailoring medical treatment to the individual genetic characteristics of patient subgroups, can potentially enable more effective therapies, improve patient outcomes and reduce healthcare costs.” Cash, cash equivalents and marketable securities totaled $19.2 million as of March 31, 2017, compared to $23.5 million as of December 31, 2016. ARCA believes that its current cash, cash equivalents and marketable securities will be sufficient to fund its operations, at its projected cost structure, through the end of 2017.  ARCA had approximately 9.2 million outstanding shares of common stock as of March 31, 2017. Research and development (R&D) expenses for the three months ended March 31, 2017 totaled $3.2 million compared to $2.6 million for the corresponding period of 2016, an increase of approximately $0.7 million.  The increase in R&D expenses in the first quarter of 2017 as compared to the first quarter of 2016 was primarily due to increased expenses for the GENETIC-AF clinical trial, including contract research organization costs, clinical site initiation and monitoring activities, patient visit costs and increased costs to support expanding the trial into Europe.  The Company expects R&D expenses in 2017 to be higher than 2016 as it activates new clinical sites and enrolls additional patients in the GENETIC-AF clinical trial. General and administrative (G&A) expenses for the three months ended March 31, 2017 were $1.1 million compared to $1.1 million for the corresponding period in 2016, a net increase of approximately $60,000.  The increase in expenses during the first quarter of 2017 was comprised primarily of higher consulting costs.  This increase is partially offset by decreased non-cash, stock-based compensation expense in 2017, as compared to the corresponding period in 2016.  ARCA expects G&A expenses in 2017 to be higher than in 2016 as it increases administrative activities to support the GENETIC-AF clinical trial. Total operating expenses for the three months ended March 31, 2017 were $4.4 million compared to $3.7 million for the corresponding period in 2016.  The increase in total operating expenses during the first quarter of 2017 was primarily due to the increase in R&D expense due to the increased clinical expense of the GENETIC-AF clinical trial. Net loss was $4.3 million, or $0.48 per share, for the first quarter of 2017 compared to $3.6 million, or $0.40 per share, for the first quarter of 2016. GENETIC-AF is an adaptive, seamless design Phase 2B/3, multi-center, randomized, double-blind, clinical superiority trial comparing the safety and efficacy of Gencaro to TOPROL-XL (metoprolol succinate) for the treatment and prevention of recurrent atrial fibrillation or flutter (AF/AFL) in heart failure patients with reduced left ventricular ejection fraction (HFrEF). Eligible patients will have HFrEF, a history of paroxysmal AF (episodes lasting 7 days or less) or persistent AF (episodes lasting more than 7 days and less than 1 year) in the past 6 months, and the beta-1 389 arginine homozygous genotype that ARCA believes responds most favorably to Gencaro.  The primary endpoint of the study is time to first event of symptomatic AF/AFL or all-cause mortality.  The trial is currently enrolling patients in the United States, Canada and Europe. The GENETIC-AF Data Safety Monitoring Board (DSMB) will perform a pre-specified interim analysis of unblinded efficacy data when at least 150 patients have evaluable data.  A randomized patient has evaluable data either when they experience their first composite endpoint event, AF/AFL or all-cause mortality, or after completion of the 24-week primary endpoint follow-up period. The analysis will be conducted to evaluate the evidence for safety and superior efficacy of Gencaro versus the active comparator, metoprolol succinate (TOPROL-XL). The prospectively defined features of this analysis include an estimate of Gencaro effectiveness relative to TOPROL-XL and an assessment of safety as characterized by adverse events. The relative benefit estimate will utilize Bayesian statistical methods to calculate the predictive probability of the Phase 3 patient cohort hazard ratio (a measure of an effect of an intervention on an outcome of interest over time) based on the interim Phase 2B data. Prospectively defined ranges of predictive probabilities have been predetermined to define three potential outcomes based on the projection of the Phase 2B interim results: 1) transition the trial to Phase 3 based on a likelihood of achieving a statistically significant hazard ratio in favor of Gencaro (evidence of an effectiveness signal consistent with pretrial assumptions) and enroll up to a total of 620 patients (including the Phase 2B patients); 2) completion of the Phase 2B stage of the trial including 24-week follow-up of all randomized subjects (approximately 250 patients), based on an intermediate result that is potentially favorable but does not support transition of the trial to Phase 3; or, 3) immediate termination of the trial due to futility. ARCA, in collaboration with the trial Steering Committee, will determine the most appropriate path forward for the trial based on the DSMB recommendation from this interim analysis.  The unblinded statistical data available to the DSMB will not be disclosed to the Company or the public.  ARCA expects the outcome of this interim efficacy analysis in September 2017. Atrial fibrillation, the most common sustained cardiac arrhythmia, is considered an epidemic cardiovascular disease and a major public health burden.  The estimated number of individuals with AF globally in 2010 was 33.5 million. According to the 2017 American Heart Association report on Cardiovascular Disease, approximately 5.2 million people in the United States had atrial fibrillation in 2015, with medical and indirect costs totaling an estimated $31 billion.  Hospitalization rates for AF increased by 23% among U.S. adults from 2000 to 2010 and hospitalizations account for the majority of the economic cost burden associated with AF. ARCA biopharma is dedicated to developing genetically-targeted therapies for cardiovascular diseases through a precision medicine approach to drug development.  ARCA’s lead product candidate, GencaroTM (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for the potential treatment of patients with atrial fibrillation and HFrEF.  ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically-targeted atrial fibrillation prevention treatment.  ARCA has a collaboration with Medtronic, Inc. for support of the GENETIC-AF trial.  For more information, please visit www.arcabio.com. This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995.  These statements include, but are not limited to, statements regarding, the potential that the data from 150 patients will support a recommendation that the GENETIC-AF trial transition to Phase 3, the potential timeline for GENETIC-AF trial activities and related recommendations of the DSMB, potential timing for patient enrollment in the GENETIC-AF trial, the sufficiency of ARCA’s capital to support its operations, the potential for genetic variations to predict individual patient response to Gencaro, Gencaro’s potential to treat AF, future treatment options for patients with AF, and the potential for Gencaro to be the first genetically-targeted AF prevention treatment.  Such statements are based on management's current expectations and involve risks and uncertainties.  Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: ARCA’s financial resources and whether they will be sufficient to meet its business objectives and operational requirements; results of earlier clinical trials may not be confirmed in future trials; the protection and market exclusivity provided by ARCA’s intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes.  These and other factors are identified and described in more detail in ARCA’s filings with the Securities and Exchange Commission, including without limitation ARCA’s annual report on Form 10-K for the year ended December 31, 2016, and subsequent filings.  ARCA disclaims any intent or obligation to update these forward-looking statements.


ARCA Estimates Reporting Top-line Phase 2B Data in the First Quarter of 2018 Gencaro Development Program Has Been Granted Fast Track Designation by U.S. FDA WESTMINSTER, Colo., Aug. 09, 2017 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (Nasdaq:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, today announced that the GENETIC-AF trial Data and Safety Monitoring Board (DSMB) completed its pre-specified Phase 2B interim analysis. Based on its efficacy and safety review, the DSMB recommended completion of the Phase 2B trial with no changes to the trial design.  GENETIC-AF is a clinical trial evaluating GencaroTM (bucindolol hydrochloride) as a potential treatment for atrial fibrillation (AF).  The Gencaro development program has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA). “The DSMB stated that there were no safety concerns and that the efficacy results met the prespecified criteria for continuing the Phase 2B trial to completion. We are pleased with the execution of the study thus far with major pretrial assumptions reflected in the trial to date, including genotype frequency, AF/AFL event rate and patient screening rates.  We believe the DSMB recommendation is encouraging, as the trial is testing for superior efficacy over the active comparator, TOPROL-XL,” commented Dr. Michael Bristow, ARCA’s President and CEO.  “We are now focused on completing the Phase 2B trial, which we estimate should include approximately 50% more events than were available at the interim analysis.  We look forward to sharing the top-line trial results late in the first quarter of next year, and reviewing the findings with the FDA.” GENETIC-AF is a Phase 2B, adaptive design, multi-center, randomized, double-blind, superiority clinical trial comparing the safety and efficacy of Gencaro to TOPROL-XL (metoprolol succinate) for the treatment and prevention of recurrent atrial fibrillation or flutter (AF/AFL) in heart failure patients with reduced left ventricular ejection fraction (HFrEF). Eligible patients will have HFrEF, a history of paroxysmal AF (episodes lasting 7 days or less) or persistent AF (episodes lasting more than 7 days and less than 1 year) in the past 6 months, and the beta-1 389 arginine homozygous genotype that ARCA believes responds most favorably to Gencaro.  The primary endpoint of the study is time to first event of symptomatic AF/AFL or all-cause mortality.  The GENETIC-AF trial design has been reviewed by the FDA.  The trial is enrolling patients in the United States, Canada and Europe.  The Company estimates reporting top-line Phase 2B data late in the first quarter of 2018.  ARCA believes that its current cash, cash equivalents and marketable securities will be sufficient to fund its operations, at its projected cost structure, into the second quarter of 2018. The DSMB performed a pre-specified interim analysis of unblinded efficacy data from all patients randomized as of June 19, 2017.  The primary analysis on the data from these patients was conducted to evaluate the evidence of safety and superior efficacy of Gencaro versus the active comparator, metoprolol succinate (TOPROL-XL). The prospectively defined features of this analysis included an estimate of Gencaro effectiveness relative to TOPROL-XL and an assessment of safety as characterized by adverse events. The primary analysis method generated predictive probability of success (PPoS) values that were compared to prespecified PPoS boundaries constructed from Bayesian statistical modeling.  Prospectively defined PPoS ranges had been predetermined to define three potential outcomes based on the projection of the Phase 2B interim results: 1) transition the trial to Phase 3; 2) completion of the Phase 2B stage of the trial, based on an intermediate result that is potentially favorable but does not support immediate transition of the trial to Phase 3; or, 3) immediate termination of the trial due to futility, if the PPoS results fall below the boundary for completion as a Phase 2 trial. Based on the efficacy and safety data of the interim analysis, the DSMB recommended completing the Phase 2B trial with no changes to the trial design. In order to maintain the integrity of the on-going double-blind clinical trial, the unblinded statistical data available to the DSMB has not and will not be disclosed to ARCA, the trial leadership, or the investigators until the Phase 2B trial is complete. ARCA estimates reporting top-line data for the Phase 2B trial late in the first quarter of 2018. Gencaro (bucindolol hydrochloride) is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for the treatment of AF. Gencaro is considered part of the beta-blocker class of compounds because of its property of blocking both beta-1 and beta-2, receptors in the heart. The blocking of these receptors prevents them from binding with other molecules, primarily the neurotransmitter norepinephrine, or NE, which activate these receptors. ARCA believes that Gencaro is well-tolerated in cardiovascular patients because of its mild vasodilator effects. Originally developed by Bristol-Myers Squibb the active pharmaceutical ingredient in Gencaro, bucindolol hydrochloride, has been tested clinically in approximately 4,500 patients, including over 3,000 patients in seven clinical trials in HFrEF patients. Gencaro was the subject of a Phase 3 HF mortality trial in 2,708 patients, mostly in the United States, or the BEST trial. The BEST trial included a DNA bank of over 1,000 patients, which was used to evaluate the effect of genetic variation on patients’ response to Gencaro. ARCA biopharma is dedicated to developing genetically-targeted therapies for cardiovascular diseases through a precision medicine approach to drug development.  ARCA’s lead product candidate, GencaroTM (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for the potential treatment of patients with atrial fibrillation and HFrEF, currently in a Phase 2B clinical trial.  ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically-targeted atrial fibrillation prevention treatment.  ARCA has a collaboration with Medtronic, Inc. for support of the GENETIC-AF trial. The Gencaro development program has been granted Fast Track designation by the FDA.  For more information, please visit www.arcabio.com. This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995.  These statements include, but are not limited to, statements regarding, the potential that the outcome of the Phase 2B interim analysis is suggestive of a potentially positive outcome for the full Phase 2 trial, or sufficient to transition to a Phase 3 trial in the future, the potential timeline for GENETIC-AF trial activities, potential timing for the announcement of topline data for the Phase 2B portion of the GENETIC-AF trial, the sufficiency of ARCA’s capital to support its operations, the potential for genetic variations to predict individual patient response to Gencaro, Gencaro’s potential to treat AF, future treatment options for patients with AF, and the potential for Gencaro to be the first genetically-targeted AF prevention treatment.  Such statements are based on management's current expectations and involve risks and uncertainties.  Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: ARCA’s financial resources and whether they will be sufficient to meet its business objectives and operational requirements; results of earlier clinical trials may not be confirmed in future trials; the protection and market exclusivity provided by ARCA’s intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes.  These and other factors are identified and described in more detail in ARCA’s filings with the Securities and Exchange Commission, including without limitation ARCA’s annual report on Form 10-K for the year ended December 31, 2016, and subsequent filings.  ARCA disclaims any intent or obligation to update these forward-looking statements.


WESTMINSTER, Colo., Aug. 03, 2017 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (Nasdaq:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, today reported financial results for the quarter ended June 30, 2017, and provided a business update. “We continue to make progress in the GENETIC-AF clinical trial with more than 250 patients now randomized,” commented Dr. Michael Bristow, ARCA’s President and Chief Executive Officer. “We are awaiting the outcome of the ongoing DSMB interim efficacy analysis that will recommend the next steps for this adaptive, seamless design trial - transitioning to Phase 3 and enrolling an additional 370 patients; completing Phase 2B with approximately 250 patients; or, stopping immediately for futility.  We expect the outcome of this important clinical milestone in August.” Cash, cash equivalents and marketable securities totaled $16.0 million as of June 30, 2017, compared to $23.5 million as of December 31, 2016. ARCA had approximately 10.1 million outstanding shares of common stock as of June 30, 2017.  Subsequent to June 30, 2017, the Company sold an aggregate of 1,634,158 shares of common stock through its existing “at the market offering”, raising net proceeds of approximately $3.9 million.  As of July 25, 2017, ARCA has sold all shares available under the prospectus to its registration statement on Form S-3 (No. 333-217459) and does not currently anticipate making any additional sales under this facility.  ARCA believes that its current cash, cash equivalents and marketable securities will be sufficient to fund its operations, at its projected cost structure, through the end of 2017. Research and development (R&D) expenses for the three months ended June 30, 2017 totaled $4.5 million compared to $2.9 million for the corresponding period of 2016, an increase of approximately $1.6 million.  R&D expense for the six months ended June 30, 2017 totaled $7.8 million compared to $5.5 million for the corresponding period of 2016, an increase of approximately $2.2 million.  The increase in R&D expense in the three and six month periods ended June 30, 2017 was due primarily to the increased expense of ARCA’s GENETIC AF clinical trial, including contract research organization costs, clinical site initiation and monitoring activities, patient visit costs and increased costs to support expanding the trial into Europe.  The Company expects R&D expenses in 2017 to be higher than 2016 as it activates new clinical sites and enrolls additional patients in the GENETIC-AF clinical trial. General and administrative (G&A) expenses for the three months ended June 30, 2017 were $1.1 million compared to $1.0 million for the corresponding period in 2016, a net increase of approximately $23,000.  G&A expenses totaled $2.2 million for the six months ended June 30, 2017 as compared to $2.1 million for the corresponding period in 2016, a net increase of approximately $84,000.  The increase for the three and six month periods is comprised primarily of higher consulting costs and professional fees.  These increases are partially offset by decreased non-cash, stock-based compensation expense in 2017, as compared to the corresponding periods in 2016.  ARCA expects G&A expenses in 2017 to be higher than in 2016 as it increases administrative activities to support the GENETIC-AF clinical trial. Total operating expenses for the three months ended June 30, 2017 were $5.6 million compared to $3.9 million for the corresponding period in 2016.  Total operating expenses for the six months ended June 30, 2017 were $9.9 million compared to $7.6 million for the corresponding period in 2016.  The increase in total operating for the three and six month periods was primarily due to the increase in R&D expense due to the increased clinical expense of the GENETIC-AF clinical trial. Net loss was $5.5 million, or $0.59 per share, for the second quarter of 2017 compared to $3.9 million, or $0.43 per share, for the second quarter of 2016.  Net loss for the six months ended June 30, 2017 was $9.9 million, or $1.07 per share, compared to $7.5 million, or $0.83 per share, for the corresponding period in 2016. GENETIC-AF is an adaptive, seamless design Phase 2B/3, multi-center, randomized, double-blind, superiority clinical trial comparing the safety and efficacy of Gencaro to Toprol-XL (metoprolol succinate) for the treatment and prevention of recurrent atrial fibrillation or flutter (AF/AFL) in heart failure patients with reduced left ventricular ejection fraction (HFrEF). Eligible patients will have HFrEF, a history of paroxysmal AF (episodes lasting 7 days or less) or persistent AF (episodes lasting more than 7 days and less than 1 year) in the past 6 months, and the beta-1 389 arginine homozygous genotype that ARCA believes responds most favorably to Gencaro.  The primary endpoint of the study is time to first event of symptomatic AF/AFL or all-cause mortality.  The GENETIC-AF trial design has been reviewed by the FDA.  The trial is currently enrolling patients in the United States, Canada and Europe. The GENETIC-AF Data and Safety Monitoring Board (DSMB) is performing a pre-specified interim analysis of unblinded efficacy data. The primary analysis will be conducted to evaluate the evidence for safety and superior efficacy of Gencaro versus the active comparator, metoprolol succinate (TOPROL-XL). The prospectively defined features of this analysis include an estimate of Gencaro effectiveness relative to TOPROL-XL and an assessment of safety as characterized by adverse events. The primary analysis method will generate predictive probability of success (PPoS) values that will be compared to prespecified PPoS boundaries constructed from Bayesian statistical modeling.  Prospectively defined PPoS ranges have been predetermined to define three potential outcomes based on the projection of the Phase 2B interim results: 1)  transition the trial to Phase 3 based on a likelihood of achieving a statistically significant hazard ratio in favor of Gencaro (evidence of an effectiveness signal consistent with pretrial assumptions) and enroll up to a total of 620 patients (including the Phase 2B patients); 2)  completion of the Phase 2B stage of the trial including 24-week follow-up of all randomized subjects, based on an intermediate result that is potentially favorable but does not support transition of the trial to Phase 3; or, 3)  immediate termination of the trial due to futility, if the PPoS results fall below the boundary for completion as a Phase 2 trial. ARCA, in collaboration with the GENETIC-AF Steering Committee, will determine the most appropriate path forward for the trial based on the DSMB recommendation from this interim analysis.  The Company expects to announce the DSMB’s recommendation based on this interim analysis in August 2017.  The unblinded statistical data available to the DSMB will not be disclosed to ARCA or the public. ARCA biopharma is dedicated to developing genetically-targeted therapies for cardiovascular diseases through a precision medicine approach to drug development.  ARCA’s lead product candidate, GencaroTM (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for the potential treatment of patients with atrial fibrillation and HFrEF.  ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically-targeted atrial fibrillation prevention treatment.  ARCA has a collaboration with Medtronic, Inc. for support of the GENETIC-AF trial. The Gencaro development program has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA).  For more information, please visit www.arcabio.com. This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995.  These statements include, but are not limited to, statements regarding, the potential that the data from the interim analysis will support a recommendation that the GENETIC-AF trial transition to Phase 3 or the completion of Phase 2, the potential timeline for GENETIC-AF trial activities and related recommendations of the DSMB, potential timing for patient enrollment in the GENETIC-AF trial, the sufficiency of ARCA’s capital to support its operations, the potential for genetic variations to predict individual patient response to Gencaro, Gencaro’s potential to treat AF, future treatment options for patients with AF, and the potential for Gencaro to be the first genetically-targeted AF prevention treatment.  Such statements are based on management's current expectations and involve risks and uncertainties.  Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: ARCA’s financial resources and whether they will be sufficient to meet its business objectives and operational requirements; results of earlier clinical trials may not be confirmed in future trials; the protection and market exclusivity provided by ARCA’s intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes.  These and other factors are identified and described in more detail in ARCA’s filings with the Securities and Exchange Commission, including without limitation ARCA’s annual report on Form 10-K for the year ended December 31, 2016, and subsequent filings.  ARCA disclaims any intent or obligation to update these forward-looking statements.


GENETIC-AF Evaluating Gencaro as Potentially First Genetically-Targeted Treatment for Atrial Fibrillation ARCA Estimates Reporting Top-line Phase 2B Data in the First Quarter of 2018 WESTMINSTER, Colo., Aug. 16, 2017 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (Nasdaq:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, today announced the completion of enrollment for GENETIC-AF, a Phase 2B, double-blind, superiority clinical trial evaluating GencaroTM (bucindolol hydrochloride) as a potential genetically-targeted treatment for atrial fibrillation (AF).  ARCA expects to report top-line Phase 2B data late in the first quarter of 2018. A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740 Two-hundred sixty-seven patients were randomized into the trial, slightly exceeding the target enrollment of 250 patients.  The trial enrolled patients from the United States, Canada and Europe. “We believe reaching our target enrollment in GENETIC-AF represents a key clinical milestone for ARCA and we look forward to reporting top-line data for the trial, which we estimate should include approximately 50% more events than were available at the recently conducted interim analysis,” commented Dr. Michael Bristow, ARCA’s President and CEO.  “I would like to thank our clinical investigators as well as the patients and their families for their participation.  We will continue working diligently to advance Gencaro’s pharmacogenetic clinical and regulatory development." GENETIC-AF is a Phase 2B, multi-center, randomized, double-blind, superiority clinical trial comparing the safety and efficacy of Gencaro to Toprol-XL (metoprolol succinate) for the treatment and prevention of recurrent atrial fibrillation or flutter (AF/AFL) in heart failure patients with reduced left ventricular ejection fraction (HFrEF).  Eligible patients have HFrEF, a history of paroxysmal AF (episodes lasting 7 days or less) or persistent AF (episodes lasting more than 7 days and less than 1 year) in the past 6 months, and the beta-1 389 arginine homozygous genotype that ARCA believes responds most favorably to Gencaro.  The GENETIC-AF Data and Safety Monitoring Board (DSMB) conducted a pre-specified interim analysis of all patients randomized as of June 19, 2017.  Based on its efficacy and safety review, the DSMB recommended completion of the Phase 2B trial with no changes to the trial design and indicated that there were no safety concerns. ARCA biopharma is dedicated to developing genetically-targeted therapies for cardiovascular diseases through a precision medicine approach to drug development.  ARCA’s lead product candidate, GencaroTM (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for the potential treatment of patients with atrial fibrillation and HFrEF, currently in a Phase 2B clinical trial.  ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically-targeted atrial fibrillation prevention treatment.  ARCA has a collaboration with Medtronic, Inc. for support of the GENETIC-AF trial. The Gencaro development program has been granted Fast Track designation by the FDA.  For more information, please visit www.arcabio.com. This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995.  These statements include, but are not limited to, statements regarding, the potential timeline for GENETIC-AF trial activities, potential timing for the announcement of topline data for the Phase 2B GENETIC-AF trial, the sufficiency of ARCA’s capital to support its operations, the expected features and characteristics of Gencaro, including the potential for genetic variations to predict individual patient response to Gencaro, Gencaro’s potential to treat AF, future treatment options for patients with AF, and the potential for Gencaro to be the first genetically-targeted AF prevention treatment.  Such statements are based on management's current expectations and involve risks and uncertainties.  Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: ARCA’s financial resources and whether they will be sufficient to meet its business objectives and operational requirements; results of earlier clinical trials may not be confirmed in future trials; the protection and market exclusivity provided by ARCA’s intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes.  These and other factors are identified and described in more detail in ARCA’s filings with the Securities and Exchange Commission, including without limitation ARCA’s annual report on Form 10-K for the year ended December 31, 2016, and subsequent filings.  ARCA disclaims any intent or obligation to update these forward-looking statements.


GENETIC-AF Evaluating Gencaro as Potentially First Genetically-Targeted Treatment for Atrial Fibrillation WESTMINSTER, Colo., June 20, 2017 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (Nasdaq:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, today announced database lock for the GENETIC-AF Phase 2B interim efficacy analysis, to be conducted by the trial Data Safety Monitoring Board (DSMB).   GENETIC-AF is a seamless design Phase 2B/3 clinical trial evaluating GencaroTM (bucindolol hydrochloride) as a potential treatment for atrial fibrillation (AF). The Company expects to announce the DSMB’s recommendation based on this interim analysis in August 2017.  The Gencaro development program has previously been granted Fast Track designation by the U.S. Food and Drug Administration (FDA). A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740 “Reaching database lock for the interim analysis and the collection and processing of trial data for the DSMB mark important points in the development of Gencaro. We are hopeful a positive DSMB recommendation will further support our data-driven rationale for development of the first genetically-targeted treatment candidate for atrial fibrillation in heart failure patients,” commented Dr. Michael Bristow, ARCA’s President and CEO.  “Based on our view of the strength of prior AF prevention data from the BEST trial and pursuant to discussions with the FDA, we have incorporated a seamless design feature for this trial. Beyond the potential for a positive recommendation of completing GENETIC-AF as a Phase 2B trial, the interim analysis allows for a recommendation to advance directly to Phase 3 if the analyzed Phase 2B cohort is responding favorably to treatment, with retention of these patients’ data in the final Phase 3 analysis. This approach substantially reduces the number of patients required to complete Phase 3, potentially allowing for a more rapid development program devoid of the risks of starting a new trial dissociated from a positive Phase 2 experience.” GENETIC-AF is an adaptive, seamless design Phase 2B/3, multi-center, randomized, double-blind, superiority clinical trial comparing the safety and efficacy of Gencaro to Toprol-XL (metoprolol succinate) for the treatment and prevention of recurrent atrial fibrillation or flutter (AF/AFL) in heart failure patients with reduced left ventricular ejection fraction (HFrEF). Eligible patients will have HFrEF, a history of paroxysmal AF (episodes lasting 7 days or less) or persistent AF (episodes lasting more than 7 days and less than 1 year) in the past 6 months, and the beta-1 389 arginine homozygous genotype that ARCA believes responds most favorably to Gencaro.  The primary endpoint of the study is time to first event of symptomatic AF/AFL or all-cause mortality.  The GENETIC-AF trial design has been reviewed by the FDA.  The trial is currently enrolling patients in the United States, Canada and Europe. The DSMB will perform a pre-specified interim analysis of unblinded efficacy data from a minimum of 150 patients with evaluable data.  A randomized patient has evaluable data either when they experience their first composite endpoint event, AF/AFL or all-cause mortality, or after completion of the 24-week primary endpoint follow-up period. The primary analysis will include data from all randomized subjects at the time of database lock. The primary analysis will be conducted to evaluate the evidence for safety and superior efficacy of Gencaro versus the active comparator, metoprolol succinate (TOPROL-XL). The prospectively defined features of this analysis include an estimate of Gencaro effectiveness relative to TOPROL-XL and an assessment of safety as characterized by adverse events. The primary analysis method will generate predictive probability of success (PPoS) values that will be compared to prespecified PPoS boundaries constructed from Bayesian statistical modeling.  Prospectively defined PPoS ranges have been predetermined to define three potential outcomes based on the projection of the Phase 2B interim results: 1) transition the trial to Phase 3 based on a likelihood of achieving a statistically significant hazard ratio in favor of Gencaro (evidence of an effectiveness signal consistent with pretrial assumptions) and enroll up to a total of 620 patients (including the Phase 2B patients); 2) completion of the Phase 2B stage of the trial including 24-week follow-up of all randomized subjects (approximately 250 patients), based on an intermediate result that is potentially favorable but does not support transition of the trial to Phase 3; or, 3) immediate termination of the trial due to futility, if the PPoS results fall below the boundary for completion as a Phase 2 trial. ARCA, in collaboration with the trial Steering Committee, will determine the most appropriate path forward for the trial based on the DSMB recommendation from this interim analysis.  The unblinded statistical data available to the DSMB will not be disclosed to the Company or the public. ARCA biopharma is dedicated to developing genetically-targeted therapies for cardiovascular diseases through a precision medicine approach to drug development.  ARCA’s lead product candidate, GencaroTM (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for the potential treatment of patients with atrial fibrillation and HFrEF.  ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically-targeted atrial fibrillation prevention treatment.  ARCA has a collaboration with Medtronic, Inc. for support of the GENETIC-AF trial. The Gencaro development program has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA).  For more information, please visit www.arcabio.com. This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995.  These statements include, but are not limited to, statements regarding, the potential that the data from at least 150 patients will support a recommendation that the GENETIC-AF trial transition to Phase 3, the potential timeline for GENETIC-AF trial activities and related recommendations of the DSMB, potential timing for patient enrollment in the GENETIC-AF trial, the sufficiency of ARCA’s capital to support its operations, the potential for genetic variations to predict individual patient response to Gencaro, Gencaro’s potential to treat AF, future treatment options for patients with AF, and the potential for Gencaro to be the first genetically-targeted AF prevention treatment.  Such statements are based on management's current expectations and involve risks and uncertainties.  Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: ARCA’s financial resources and whether they will be sufficient to meet its business objectives and operational requirements; results of earlier clinical trials may not be confirmed in future trials; the protection and market exclusivity provided by ARCA’s intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes.  These and other factors are identified and described in more detail in ARCA’s filings with the Securities and Exchange Commission, including without limitation ARCA’s annual report on Form 10-K for the year ended December 31, 2016, and subsequent filings.  ARCA disclaims any intent or obligation to update these forward-looking statements.


Patent
ARCA biopharma | Date: 2016-09-16

Disclosed is bucindolol substantially free of its R-stereoisomer. Also disclosed are pharmaceutical compositions that include bucindolol substantially free of its R-stereoisomer or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier. Also disclosed are methods of treating a patient that involve administering to the patient a therapeutically effective amount of a composition of the present invention.


Patent
ARCA biopharma | Date: 2014-04-17

Anti-LRP6 antibodies and antigen-binding fragments thereof, as well as pharmaceutical compositions comprising such antibodies and antigen-binding fragments are described. These anti-LRP6 antibodies can be used to enhance Wnt activity and/or antagonize Dkk1 activity. Also described are methods of therapy using such antibodies and antigen-binding regions to bind modulate Wnt/LRP6 signaling to promote tissue homeostasis, regeneration and repair in diseases such as, but not limited to, bone disorders, such as osteoporosis, rheumatoid arthritis, and osteolytic lesions caused by osteoarthritis and multiple myeloma, gastrointestinal disease and wound healing.


Patent
ARCA biopharma | Date: 2015-03-26

Anti-NTB-A antibodies and antigen-binding fragments thereof, as well as pharmaceutical compositions comprising such antibodies and antigen-binding fragments are described. Also described are methods of using such antibodies and antigen-binding regions to bind NTB-A and treat diseases, such as hematologic malignancies, which are characterized by expression of NTB-A.


Patent
ARCA biopharma | Date: 2015-01-06

Disclosed is bucindolol substantially free of its R-stereoisomer. Also disclosed are pharmaceutical compositions that include bucindolol substantially free of its R-stereoisomer or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier. Also disclosed are methods of treating a patient that involve administering to the patient a therapeutically effective amount of a composition of the present invention.


News Article | February 21, 2017
Site: www.businesswire.com

WESTMINSTER, Colo.--(BUSINESS WIRE)--ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, today announced that Anders Hove, M.D., has joined its Board of Directors. “Anders brings decades of experience building and advising biopharmaceutical companies,” said Dr. Michael R. Bristow, President and Chief Executive Officer of ARCA. “With his expertise on both the corporate and investment sides of the industry, Anders’ input and guidance will be valuable to our Board of Directors as we continue the development of Gencaro and seek to deliver value to our stockholders.” Dr. Hove has more than 20 years of experience investing in and helping build biopharmaceutical companies. He has served on the Boards of Directors of numerous private and public companies, currently serving on the Boards of two private biopharmaceutical companies. In 2011, Dr. Hove was named to Forbes’ Midas List, which ranked the top venture capitalists in life sciences and technology. Dr. Hove received a M.Sc. in Biotechnology Engineering from the Technical University of Denmark, an M.D. from the University of Copenhagen and an M.B.A. from the Institut Européen d'Administration des Affaires, or INSEAD. “I am honored to join the ARCA Board of Directors,” said Dr. Hove. “This is an exciting time for the organization with the GENETIC-AF clinical trial interim efficacy analysis expected later this year. I believe there is a significant opportunity for developing genetically-targeted cardiovascular therapeutics, for which ARCA is well-positioned.” ARCA biopharma is dedicated to developing genetically-targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. The Company's lead product candidate, GencaroTM (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for atrial fibrillation. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically-targeted atrial fibrillation prevention treatment. ARCA has a collaboration with Medtronic, Inc. for support of the GENETIC-AF trial. For more information, please visit www.arcabio.com. This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding, the potential timeline for GENETIC-AF trial activities, the potential for genetic variations to predict individual patient response to Gencaro, Gencaro’s potential to treat atrial fibrillation, future treatment options for patients with atrial fibrillation, the potential for ARCA to expand its cardiovascular pipeline, the opportunity related to developing genetically-targeted cardiovascular therapeutics and the potential for Gencaro to be the first genetically-targeted atrial fibrillation prevention treatment. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: the Company's financial resources and whether they will be sufficient to meet the Company's business objectives and operational requirements; results of earlier clinical trials may not be confirmed in future trials, the protection and market exclusivity provided by the Company’s intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA’s filings with the Securities and Exchange Commission, including without limitation the Company’s annual report on Form 10-K for the year ended December 31, 2015, and subsequent filings. The Company disclaims any intent or obligation to update these forward-looking statements.

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