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News Article | May 12, 2017
Site: globenewswire.com

HALLE (SAALE), Germany, 12 May 2017 - Probiodrug AG (Euronext Amsterdam: PBD), a biopharmaceutical company developing novel therapeutic solutions to treat Alzheimer's disease (AD), today announces its first quarter business update for the period ending 31 March 2017, in the form of an interim management report. The interim management report for the first quarter 2017 is available for download on the company website (http://www.probiodrug.de/investors/reports-and-presentations/). Commenting on the first quarter, Dr Konrad Glund, Chief Executive Officer of Probiodrug, said: "In the first quarter of 2017 we successfully continued to execute on our corporate strategy. The Last Patient Last Visit (LPLV) represents an important step towards the conclusion of our first patient trial with PQ912. The promising data obtained with PQ912 and PBD-C06 in AD animal models further demonstrates the potential of the pGlu-Abeta treatment concept. Positive treatment results with PQ912 in a Huntington's disease animal model provide support for evaluating PQ912 in patients with Huntington`s disease (HD) in the future, another neurological disease based on misfolded proteins." Pipeline update Probiodrug`s therapeutic approach targets pyroglutamate-Abeta (pGlu-Abeta, also called N3pG Abeta) as a therapeutic strategy to fight Alzheimer's disease. This modified Abeta is considered to be linked with disease initiation and progression by seeding the formation of soluble neurotoxic amyloid oligomers. Probiodrug is developing proprietary product candidates to target toxic pGlu-Abeta via two modes of action: by (i) inhibiting the production of pGlu-Abeta; and (ii) clearing existing pGlu-Abeta from the brain. Probiodrug's innovative approach is based on the development of specific inhibitors for the enzyme Glutaminyl Cyclase (QC), which is instrumental in the creation of pGlu-Abeta. In addition, the company is developing a monoclonal antibody targeting pGlu-Abeta to enhance its clearance. To date, Probiodrug's pipeline consists of two small molecule inhibitors of the QC-enzyme, PQ912 and PQ1565, and a monoclonal antibody, PBD-C06, targeting pGlu-Abeta. PQ912 Probiodrug is running a Phase 2a trial, the "SAPHIR" study, of its lead product candidate PQ912. In a preceding Phase 1 study with healthy young and elderly volunteers, PQ912 was shown to be safe and well tolerated and revealed high QC-inhibition. PQ912 is the first QC-inhibitor being tested in patients. The Phase 2a study is a randomized, double-blind multi-center study which plans to enrol a total of 110 patients with early stage Alzheimer's disease. The study is led by internationally renowned experts in AD in seven European countries at 21 sites, with the Alzheimer Center, VU Medical Center (VUmc), Amsterdam being the lead center. The primary endpoint of the trial is the safety and tolerability of PQ912 compared with placebo over a three-month treatment period. Additionally, a set of exploratory read-outs comprising cognitive tests, functional assessments by EEG and functional MRI and new molecular biomarkers in CSF will be used to evaluate the compound's effect on the pathology of the disease. In this study Mini-Mental State Examination (MMSE) and the Cogstate neuro-psychological test battery (NTB) are monitored blindly every 30 patients to ensure consistency and reliability of ratings. First blinded results at baseline show that the mean MMSE scores from the 120 randomised patients is 25.3, the mean age is 73 years and gender distribution is 64 female and 56 male. Current results indicate a low variability and therefore the high quality of the assessments being used. Recruitment has been completed in mid-December 2016. A total of 120 patients have been randomised, surpassing the 110 patients planned in the study protocol. Full unblinded results of the SAPHIR study are expected in the second quarter of 2017. PBD-C06 PBD-C06 is a monoclonal antibody, currently in preclinical stage. PBD-C06 targets pGlu-Abeta, aiming to selectively clear the brain of pGlu-Abeta while leaving non-toxic forms of Abeta untouched. PBD-C06 has been successfully humanized and also de-immunized to avoid detection by the patient's endogenous immune system. For the first time for an anti-pGlu-Abeta approach PBD-C06 has not only shown the ability to reduce Abeta/plaques but also to significantly improve cognitive deficits in aged Alzheimer's mice. Moreover, no evidence was found of increased microhemorrhages after treatment with PBD-C06. The development of the manufacturing process of this molecule is running. PQ1565 PQ1565 is a QC-inhibitor, currently in preclinical stage. The product candidate has shown attractive drug-like properties in preclinical studies. The GMP process for this molecule is being implemented. The next development steps are in preparation and respective decisions would be made in connection with the readout of the SAPHIR trial. New promising results from pharmacological studies with PQ912 and PBD-C06 in AD animal models and an evaluation of new biomarkers in cerebrospinal fluid (CSF) from AD patients presented Three updates on the advancement of its product candidates and the results of a Biomarker research collaboration have been presented at the 13th International Conference on Alzheimer's and Parkinson's Diseases (AD/PDTM 2017), Vienna, Austria. The conference took place from 29th March to 2nd April 2017. Financials The first quarter of 2017 showed an increase of research and development expenses to EUR 2,268k compared to EUR 1,974k in the first quarter of 2016, reflecting mainly the costs for the Phase 2 trial (SAPHIR Study) of PQ912. General and administrative expenses amounted to EUR 507k compared to EUR 597k in the first quarter of 2016, reflecting more intrayear shifts than actual savings. In the first quarter 2017 the Company has not generated any revenues, also in line with the corporate planning. Correspondingly, the comprehensive loss of the reporting period was EUR 2,798k, compared to EUR 2,596k in the first quarter of 2016. All results are in line with management expectations. Probiodrug held EUR 18.7 million in cash and cash equivalents as of 31 March 2017. Last Patient Last Visit (LPLV) accomplished in the SAPHIR Study On 07 April 2017 Probiodrug announced that the Last Patient's Last Visit (LPLV) occurred on 05 April 2017 in the currently running Phase 2a SAPHIR study investigating the QC-inhibitor PQ912. PQ912 demonstrates beneficial effects in a preclinical Huntington`s disease model On 10 April 2017 Probiodrug announced results of a preclinical study targeting Glutaminyl Cyclases (QCs) in Huntington`s disease (HD). The results have been presented at the 12th Annual HD Therapeutics Conference of the CHDI Foundation on 23rd of April in St. Julian's, Malta. HD is the most common inherited neurodegenerative disorder where, due to a mutation, the poly-glutamine amino acid sequence is expanded in a protein called huntingtin (HTT). There is currently no disease modifying therapy for this condition. PQ912 clearly improved several signs of the disease in a well characterized BACHD mouse model of HD. BACHD mice carry the human gene for mutant HTT (mHTT). At six weeks old, parallel to the onset of first behavioral, metabolic and neuropathological signs of the disease, the BACHD mice were treated for 18 weeks with food pellets containing PQ912. PQ912 treatment for 18 weeks caused a significant reduction (approximately 30%) in brain mHTT levels. These lowered mHTT levels were associated with reduced levels of the inflammation/gliosis marker GFAP-protein, a striking normalization of the abnormal body weight gain and energy metabolism as well as a normalization of several mRNA levels coding for HSPs in BACHD mice at 24 weeks of age. Data were generated in collaboration with Stephan von Hörsten of the University Hospital Erlangen, part of Friedrich-Alexander-University (FAU), Erlangen, Germany. Invitation to Probiodrug`s Ordinary General Meeting of Shareholders on 13 June 2017 On 03 May 2017 Probiodrug invited its shareholders to its ordinary general meeting of shareholders to be held on Tuesday, 13 June 2017 at 11:00 am (CEST), at the Mercure Hotel MOA Berlin, Stephanstraße 41, 10559 Berlin, Germany. The relevant documents can be found at http://www.probiodrug.de/investors/annual-shareholders-meeting-2017/. For more information, please contact: Notes to Editors: About Probiodrug AG Headquartered in Halle (Saale), Germany, Probiodrug AG (Euronext Amsterdam: PBD) is a biopharmaceutical company focused on the development of new therapeutic products for the treatment of Alzheimer's disease. Founded in 1997, the company successfully developed a novel therapeutic concept for diabetes - the DP4 inhibitors - which provided the basis for a novel class of antidiabetics - the gliptins. Its core capabilities are based on its long-standing expertise in the elucidation of the structure and function of enzymes involved in the modification of proteins and peptides, which play a central role in pathological conditions. Today Probiodrug's aim is to become a leading company in the development of Alzheimer's disease treatments and to thereby provide a better life for Alzheimer's disease patients. It has identified a new therapeutic concept linked to disease initiation and progression. The development approaches are targeting pyroglutamate-Abeta (pGlu-Abeta) as a therapeutic strategy to fight Alzheimer's disease. The Company has medical use and composition of matter patents related to the inhibition of Glutaminyl Cyclase (QC) and anti-pGlu-Abeta- specific monoclonal antibodies, providing it, in the Company's view, with a leading position in this field of research. Probiodrug's lead product candidate, PQ912, is a highly specific and potent inhibitor of Glutaminyl Cyclase (QC), which has shown therapeutic effects in Alzheimer's animal models. PQ912 is currently in a Phase 2a study, the SAPHIR trial. In a preceding Phase 1 study with healthy young and elderly volunteers, PQ912 has shown to be safe and well tolerated and also revealed high QC-inhibition. About Alzheimer's disease Alzheimer's disease is a neurological disorder, which is the most common form of dementia, and ultimately leads to death. Because Alzheimer's disease cannot be cured and is degenerative, the affected patients must increasingly rely on others for assistance. . Today, 47 million people live with dementia worldwide, and this number is projected to treble to more than 131 million by 2050, as populations age. Dementia also has a huge economic impact. Alzheimer's has an estimated, global societal cost of US$ 818 billion, and it will become a trillion dollar disease by 2018. (World Alzheimer Report 2016). Forward Looking Statements Information set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgment of Probiodrug AG as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.


News Article | May 12, 2017
Site: globenewswire.com

HALLE (SAALE), Germany, 12 May 2017 - Probiodrug AG (Euronext Amsterdam: PBD), a biopharmaceutical company developing novel therapeutic solutions to treat Alzheimer's disease (AD), today announces its first quarter business update for the period ending 31 March 2017, in the form of an interim management report. The interim management report for the first quarter 2017 is available for download on the company website (http://www.probiodrug.de/investors/reports-and-presentations/). Commenting on the first quarter, Dr Konrad Glund, Chief Executive Officer of Probiodrug, said: "In the first quarter of 2017 we successfully continued to execute on our corporate strategy. The Last Patient Last Visit (LPLV) represents an important step towards the conclusion of our first patient trial with PQ912. The promising data obtained with PQ912 and PBD-C06 in AD animal models further demonstrates the potential of the pGlu-Abeta treatment concept. Positive treatment results with PQ912 in a Huntington's disease animal model provide support for evaluating PQ912 in patients with Huntington`s disease (HD) in the future, another neurological disease based on misfolded proteins." Pipeline update Probiodrug`s therapeutic approach targets pyroglutamate-Abeta (pGlu-Abeta, also called N3pG Abeta) as a therapeutic strategy to fight Alzheimer's disease. This modified Abeta is considered to be linked with disease initiation and progression by seeding the formation of soluble neurotoxic amyloid oligomers. Probiodrug is developing proprietary product candidates to target toxic pGlu-Abeta via two modes of action: by (i) inhibiting the production of pGlu-Abeta; and (ii) clearing existing pGlu-Abeta from the brain. Probiodrug's innovative approach is based on the development of specific inhibitors for the enzyme Glutaminyl Cyclase (QC), which is instrumental in the creation of pGlu-Abeta. In addition, the company is developing a monoclonal antibody targeting pGlu-Abeta to enhance its clearance. To date, Probiodrug's pipeline consists of two small molecule inhibitors of the QC-enzyme, PQ912 and PQ1565, and a monoclonal antibody, PBD-C06, targeting pGlu-Abeta. PQ912 Probiodrug is running a Phase 2a trial, the "SAPHIR" study, of its lead product candidate PQ912. In a preceding Phase 1 study with healthy young and elderly volunteers, PQ912 was shown to be safe and well tolerated and revealed high QC-inhibition. PQ912 is the first QC-inhibitor being tested in patients. The Phase 2a study is a randomized, double-blind multi-center study which plans to enrol a total of 110 patients with early stage Alzheimer's disease. The study is led by internationally renowned experts in AD in seven European countries at 21 sites, with the Alzheimer Center, VU Medical Center (VUmc), Amsterdam being the lead center. The primary endpoint of the trial is the safety and tolerability of PQ912 compared with placebo over a three-month treatment period. Additionally, a set of exploratory read-outs comprising cognitive tests, functional assessments by EEG and functional MRI and new molecular biomarkers in CSF will be used to evaluate the compound's effect on the pathology of the disease. In this study Mini-Mental State Examination (MMSE) and the Cogstate neuro-psychological test battery (NTB) are monitored blindly every 30 patients to ensure consistency and reliability of ratings. First blinded results at baseline show that the mean MMSE scores from the 120 randomised patients is 25.3, the mean age is 73 years and gender distribution is 64 female and 56 male. Current results indicate a low variability and therefore the high quality of the assessments being used. Recruitment has been completed in mid-December 2016. A total of 120 patients have been randomised, surpassing the 110 patients planned in the study protocol. Full unblinded results of the SAPHIR study are expected in the second quarter of 2017. PBD-C06 PBD-C06 is a monoclonal antibody, currently in preclinical stage. PBD-C06 targets pGlu-Abeta, aiming to selectively clear the brain of pGlu-Abeta while leaving non-toxic forms of Abeta untouched. PBD-C06 has been successfully humanized and also de-immunized to avoid detection by the patient's endogenous immune system. For the first time for an anti-pGlu-Abeta approach PBD-C06 has not only shown the ability to reduce Abeta/plaques but also to significantly improve cognitive deficits in aged Alzheimer's mice. Moreover, no evidence was found of increased microhemorrhages after treatment with PBD-C06. The development of the manufacturing process of this molecule is running. PQ1565 PQ1565 is a QC-inhibitor, currently in preclinical stage. The product candidate has shown attractive drug-like properties in preclinical studies. The GMP process for this molecule is being implemented. The next development steps are in preparation and respective decisions would be made in connection with the readout of the SAPHIR trial. New promising results from pharmacological studies with PQ912 and PBD-C06 in AD animal models and an evaluation of new biomarkers in cerebrospinal fluid (CSF) from AD patients presented Three updates on the advancement of its product candidates and the results of a Biomarker research collaboration have been presented at the 13th International Conference on Alzheimer's and Parkinson's Diseases (AD/PDTM 2017), Vienna, Austria. The conference took place from 29th March to 2nd April 2017. Financials The first quarter of 2017 showed an increase of research and development expenses to EUR 2,268k compared to EUR 1,974k in the first quarter of 2016, reflecting mainly the costs for the Phase 2 trial (SAPHIR Study) of PQ912. General and administrative expenses amounted to EUR 507k compared to EUR 597k in the first quarter of 2016, reflecting more intrayear shifts than actual savings. In the first quarter 2017 the Company has not generated any revenues, also in line with the corporate planning. Correspondingly, the comprehensive loss of the reporting period was EUR 2,798k, compared to EUR 2,596k in the first quarter of 2016. All results are in line with management expectations. Probiodrug held EUR 18.7 million in cash and cash equivalents as of 31 March 2017. Last Patient Last Visit (LPLV) accomplished in the SAPHIR Study On 07 April 2017 Probiodrug announced that the Last Patient's Last Visit (LPLV) occurred on 05 April 2017 in the currently running Phase 2a SAPHIR study investigating the QC-inhibitor PQ912. PQ912 demonstrates beneficial effects in a preclinical Huntington`s disease model On 10 April 2017 Probiodrug announced results of a preclinical study targeting Glutaminyl Cyclases (QCs) in Huntington`s disease (HD). The results have been presented at the 12th Annual HD Therapeutics Conference of the CHDI Foundation on 23rd of April in St. Julian's, Malta. HD is the most common inherited neurodegenerative disorder where, due to a mutation, the poly-glutamine amino acid sequence is expanded in a protein called huntingtin (HTT). There is currently no disease modifying therapy for this condition. PQ912 clearly improved several signs of the disease in a well characterized BACHD mouse model of HD. BACHD mice carry the human gene for mutant HTT (mHTT). At six weeks old, parallel to the onset of first behavioral, metabolic and neuropathological signs of the disease, the BACHD mice were treated for 18 weeks with food pellets containing PQ912. PQ912 treatment for 18 weeks caused a significant reduction (approximately 30%) in brain mHTT levels. These lowered mHTT levels were associated with reduced levels of the inflammation/gliosis marker GFAP-protein, a striking normalization of the abnormal body weight gain and energy metabolism as well as a normalization of several mRNA levels coding for HSPs in BACHD mice at 24 weeks of age. Data were generated in collaboration with Stephan von Hörsten of the University Hospital Erlangen, part of Friedrich-Alexander-University (FAU), Erlangen, Germany. Invitation to Probiodrug`s Ordinary General Meeting of Shareholders on 13 June 2017 On 03 May 2017 Probiodrug invited its shareholders to its ordinary general meeting of shareholders to be held on Tuesday, 13 June 2017 at 11:00 am (CEST), at the Mercure Hotel MOA Berlin, Stephanstraße 41, 10559 Berlin, Germany. The relevant documents can be found at http://www.probiodrug.de/investors/annual-shareholders-meeting-2017/. For more information, please contact: Notes to Editors: About Probiodrug AG Headquartered in Halle (Saale), Germany, Probiodrug AG (Euronext Amsterdam: PBD) is a biopharmaceutical company focused on the development of new therapeutic products for the treatment of Alzheimer's disease. Founded in 1997, the company successfully developed a novel therapeutic concept for diabetes - the DP4 inhibitors - which provided the basis for a novel class of antidiabetics - the gliptins. Its core capabilities are based on its long-standing expertise in the elucidation of the structure and function of enzymes involved in the modification of proteins and peptides, which play a central role in pathological conditions. Today Probiodrug's aim is to become a leading company in the development of Alzheimer's disease treatments and to thereby provide a better life for Alzheimer's disease patients. It has identified a new therapeutic concept linked to disease initiation and progression. The development approaches are targeting pyroglutamate-Abeta (pGlu-Abeta) as a therapeutic strategy to fight Alzheimer's disease. The Company has medical use and composition of matter patents related to the inhibition of Glutaminyl Cyclase (QC) and anti-pGlu-Abeta- specific monoclonal antibodies, providing it, in the Company's view, with a leading position in this field of research. Probiodrug's lead product candidate, PQ912, is a highly specific and potent inhibitor of Glutaminyl Cyclase (QC), which has shown therapeutic effects in Alzheimer's animal models. PQ912 is currently in a Phase 2a study, the SAPHIR trial. In a preceding Phase 1 study with healthy young and elderly volunteers, PQ912 has shown to be safe and well tolerated and also revealed high QC-inhibition. About Alzheimer's disease Alzheimer's disease is a neurological disorder, which is the most common form of dementia, and ultimately leads to death. Because Alzheimer's disease cannot be cured and is degenerative, the affected patients must increasingly rely on others for assistance. . Today, 47 million people live with dementia worldwide, and this number is projected to treble to more than 131 million by 2050, as populations age. Dementia also has a huge economic impact. Alzheimer's has an estimated, global societal cost of US$ 818 billion, and it will become a trillion dollar disease by 2018. (World Alzheimer Report 2016). Forward Looking Statements Information set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgment of Probiodrug AG as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.


News Article | May 12, 2017
Site: globenewswire.com

HALLE (SAALE), Germany, 12 May 2017 - Probiodrug AG (Euronext Amsterdam: PBD), a biopharmaceutical company developing novel therapeutic solutions to treat Alzheimer's disease (AD), today announces its first quarter business update for the period ending 31 March 2017, in the form of an interim management report. The interim management report for the first quarter 2017 is available for download on the company website (http://www.probiodrug.de/investors/reports-and-presentations/). Commenting on the first quarter, Dr Konrad Glund, Chief Executive Officer of Probiodrug, said: "In the first quarter of 2017 we successfully continued to execute on our corporate strategy. The Last Patient Last Visit (LPLV) represents an important step towards the conclusion of our first patient trial with PQ912. The promising data obtained with PQ912 and PBD-C06 in AD animal models further demonstrates the potential of the pGlu-Abeta treatment concept. Positive treatment results with PQ912 in a Huntington's disease animal model provide support for evaluating PQ912 in patients with Huntington`s disease (HD) in the future, another neurological disease based on misfolded proteins." Pipeline update Probiodrug`s therapeutic approach targets pyroglutamate-Abeta (pGlu-Abeta, also called N3pG Abeta) as a therapeutic strategy to fight Alzheimer's disease. This modified Abeta is considered to be linked with disease initiation and progression by seeding the formation of soluble neurotoxic amyloid oligomers. Probiodrug is developing proprietary product candidates to target toxic pGlu-Abeta via two modes of action: by (i) inhibiting the production of pGlu-Abeta; and (ii) clearing existing pGlu-Abeta from the brain. Probiodrug's innovative approach is based on the development of specific inhibitors for the enzyme Glutaminyl Cyclase (QC), which is instrumental in the creation of pGlu-Abeta. In addition, the company is developing a monoclonal antibody targeting pGlu-Abeta to enhance its clearance. To date, Probiodrug's pipeline consists of two small molecule inhibitors of the QC-enzyme, PQ912 and PQ1565, and a monoclonal antibody, PBD-C06, targeting pGlu-Abeta. PQ912 Probiodrug is running a Phase 2a trial, the "SAPHIR" study, of its lead product candidate PQ912. In a preceding Phase 1 study with healthy young and elderly volunteers, PQ912 was shown to be safe and well tolerated and revealed high QC-inhibition. PQ912 is the first QC-inhibitor being tested in patients. The Phase 2a study is a randomized, double-blind multi-center study which plans to enrol a total of 110 patients with early stage Alzheimer's disease. The study is led by internationally renowned experts in AD in seven European countries at 21 sites, with the Alzheimer Center, VU Medical Center (VUmc), Amsterdam being the lead center. The primary endpoint of the trial is the safety and tolerability of PQ912 compared with placebo over a three-month treatment period. Additionally, a set of exploratory read-outs comprising cognitive tests, functional assessments by EEG and functional MRI and new molecular biomarkers in CSF will be used to evaluate the compound's effect on the pathology of the disease. In this study Mini-Mental State Examination (MMSE) and the Cogstate neuro-psychological test battery (NTB) are monitored blindly every 30 patients to ensure consistency and reliability of ratings. First blinded results at baseline show that the mean MMSE scores from the 120 randomised patients is 25.3, the mean age is 73 years and gender distribution is 64 female and 56 male. Current results indicate a low variability and therefore the high quality of the assessments being used. Recruitment has been completed in mid-December 2016. A total of 120 patients have been randomised, surpassing the 110 patients planned in the study protocol. Full unblinded results of the SAPHIR study are expected in the second quarter of 2017. PBD-C06 PBD-C06 is a monoclonal antibody, currently in preclinical stage. PBD-C06 targets pGlu-Abeta, aiming to selectively clear the brain of pGlu-Abeta while leaving non-toxic forms of Abeta untouched. PBD-C06 has been successfully humanized and also de-immunized to avoid detection by the patient's endogenous immune system. For the first time for an anti-pGlu-Abeta approach PBD-C06 has not only shown the ability to reduce Abeta/plaques but also to significantly improve cognitive deficits in aged Alzheimer's mice. Moreover, no evidence was found of increased microhemorrhages after treatment with PBD-C06. The development of the manufacturing process of this molecule is running. PQ1565 PQ1565 is a QC-inhibitor, currently in preclinical stage. The product candidate has shown attractive drug-like properties in preclinical studies. The GMP process for this molecule is being implemented. The next development steps are in preparation and respective decisions would be made in connection with the readout of the SAPHIR trial. New promising results from pharmacological studies with PQ912 and PBD-C06 in AD animal models and an evaluation of new biomarkers in cerebrospinal fluid (CSF) from AD patients presented Three updates on the advancement of its product candidates and the results of a Biomarker research collaboration have been presented at the 13th International Conference on Alzheimer's and Parkinson's Diseases (AD/PDTM 2017), Vienna, Austria. The conference took place from 29th March to 2nd April 2017. Financials The first quarter of 2017 showed an increase of research and development expenses to EUR 2,268k compared to EUR 1,974k in the first quarter of 2016, reflecting mainly the costs for the Phase 2 trial (SAPHIR Study) of PQ912. General and administrative expenses amounted to EUR 507k compared to EUR 597k in the first quarter of 2016, reflecting more intrayear shifts than actual savings. In the first quarter 2017 the Company has not generated any revenues, also in line with the corporate planning. Correspondingly, the comprehensive loss of the reporting period was EUR 2,798k, compared to EUR 2,596k in the first quarter of 2016. All results are in line with management expectations. Probiodrug held EUR 18.7 million in cash and cash equivalents as of 31 March 2017. Last Patient Last Visit (LPLV) accomplished in the SAPHIR Study On 07 April 2017 Probiodrug announced that the Last Patient's Last Visit (LPLV) occurred on 05 April 2017 in the currently running Phase 2a SAPHIR study investigating the QC-inhibitor PQ912. PQ912 demonstrates beneficial effects in a preclinical Huntington`s disease model On 10 April 2017 Probiodrug announced results of a preclinical study targeting Glutaminyl Cyclases (QCs) in Huntington`s disease (HD). The results have been presented at the 12th Annual HD Therapeutics Conference of the CHDI Foundation on 23rd of April in St. Julian's, Malta. HD is the most common inherited neurodegenerative disorder where, due to a mutation, the poly-glutamine amino acid sequence is expanded in a protein called huntingtin (HTT). There is currently no disease modifying therapy for this condition. PQ912 clearly improved several signs of the disease in a well characterized BACHD mouse model of HD. BACHD mice carry the human gene for mutant HTT (mHTT). At six weeks old, parallel to the onset of first behavioral, metabolic and neuropathological signs of the disease, the BACHD mice were treated for 18 weeks with food pellets containing PQ912. PQ912 treatment for 18 weeks caused a significant reduction (approximately 30%) in brain mHTT levels. These lowered mHTT levels were associated with reduced levels of the inflammation/gliosis marker GFAP-protein, a striking normalization of the abnormal body weight gain and energy metabolism as well as a normalization of several mRNA levels coding for HSPs in BACHD mice at 24 weeks of age. Data were generated in collaboration with Stephan von Hörsten of the University Hospital Erlangen, part of Friedrich-Alexander-University (FAU), Erlangen, Germany. Invitation to Probiodrug`s Ordinary General Meeting of Shareholders on 13 June 2017 On 03 May 2017 Probiodrug invited its shareholders to its ordinary general meeting of shareholders to be held on Tuesday, 13 June 2017 at 11:00 am (CEST), at the Mercure Hotel MOA Berlin, Stephanstraße 41, 10559 Berlin, Germany. The relevant documents can be found at http://www.probiodrug.de/investors/annual-shareholders-meeting-2017/. For more information, please contact: Notes to Editors: About Probiodrug AG Headquartered in Halle (Saale), Germany, Probiodrug AG (Euronext Amsterdam: PBD) is a biopharmaceutical company focused on the development of new therapeutic products for the treatment of Alzheimer's disease. Founded in 1997, the company successfully developed a novel therapeutic concept for diabetes - the DP4 inhibitors - which provided the basis for a novel class of antidiabetics - the gliptins. Its core capabilities are based on its long-standing expertise in the elucidation of the structure and function of enzymes involved in the modification of proteins and peptides, which play a central role in pathological conditions. Today Probiodrug's aim is to become a leading company in the development of Alzheimer's disease treatments and to thereby provide a better life for Alzheimer's disease patients. It has identified a new therapeutic concept linked to disease initiation and progression. The development approaches are targeting pyroglutamate-Abeta (pGlu-Abeta) as a therapeutic strategy to fight Alzheimer's disease. The Company has medical use and composition of matter patents related to the inhibition of Glutaminyl Cyclase (QC) and anti-pGlu-Abeta- specific monoclonal antibodies, providing it, in the Company's view, with a leading position in this field of research. Probiodrug's lead product candidate, PQ912, is a highly specific and potent inhibitor of Glutaminyl Cyclase (QC), which has shown therapeutic effects in Alzheimer's animal models. PQ912 is currently in a Phase 2a study, the SAPHIR trial. In a preceding Phase 1 study with healthy young and elderly volunteers, PQ912 has shown to be safe and well tolerated and also revealed high QC-inhibition. About Alzheimer's disease Alzheimer's disease is a neurological disorder, which is the most common form of dementia, and ultimately leads to death. Because Alzheimer's disease cannot be cured and is degenerative, the affected patients must increasingly rely on others for assistance. . Today, 47 million people live with dementia worldwide, and this number is projected to treble to more than 131 million by 2050, as populations age. Dementia also has a huge economic impact. Alzheimer's has an estimated, global societal cost of US$ 818 billion, and it will become a trillion dollar disease by 2018. (World Alzheimer Report 2016). Forward Looking Statements Information set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgment of Probiodrug AG as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.


Lundstrom M.,Lund University | Barry P.,University of Victoria | Henry Y.,VUmc | Rosen P.,Oxford Eye Hospital | Stenevi U.,Sahlgrens University Hospital
Journal of Cataract and Refractive Surgery | Year: 2013

Purpose: To analyze the visual outcome after cataract surgery. Setting: Cataract surgery clinics in 15 European countries. Design: Database study. Methods: Data were drawn from case series of cataract extractions reported to the European Registry of Quality Outcomes for Cataract and Refractive Surgery database. These data were entered into the database via the Web by surgeons or by transfer from existing national registries or electronic medical record systems. The database contains individual anonymous data on preoperative, intraoperative, and postoperative measurements. Results: Data on 368 256 cataract extractions were available for analysis. The best visual outcome was achieved in age groups 40 to 74 years, and men showed a higher percentage of excellent vision (1.0 [20/20] or better) than women. A corrected distance visual acuity (CDVA) of 0.5 (20/40) or better and of 1.0 (20/20) or better was achieved in 94.3% and 61.3% of cases, respectively. Ocular comorbidity and postoperative complications were the strongest influences on the visual outcome; however, surgical complications and ocular changes requiring complex surgery also had a negative influence. Deterioration of visual acuity after the surgery (n= 6112 [1.7% of all cases]) was most common in patients with a good preoperative visual acuity. Conclusions: The visual outcomes of cataract surgery were excellent, with 61.3% of patients achieving a corrected distance visual acuity of 1.0 (20/20) or better. Age and sex influenced the visual outcomes, but the greatest influences were short-term postoperative complications, ocular comorbidity, surgical complications, and complex surgery. A weakness of the study could be that some of the data is self-reported to the registry. Financial Disclosure: No author has a financial or proprietary interest in any material or method mentioned. © 2013 ASCRS and ESCRS.


Petzold A.,VUmc | Petzold A.,University College London | Plant G.T.,Moorfields Eye Hospital
Autoimmunity Reviews | Year: 2014

The spectrum of autoimmune optic neuropathies (ON) is extending. The phenotypic spectrum includes single isolated optic neuritis (SION), relapsing isolated optic neuritis (RION), chronic relapsing inflammatory optic neuropathy (CRION), the neuromyelitis optica (NMO) spectrum disorder, multiple sclerosis associated optic neuritis (MSON) and unclassified optic neuritis (UCON) forms. Epidemiological data suggests a slight female predominance. The ethnic heritage is relevant as Caucasian patients are more likely to suffer from MSON, whilst SION, RION, CRION and NMO are more frequent in non-Caucasian patients. Importantly, prognosis for recovery of visual function is good in MSON, but poorer in NMO and CRION which also have a high chance for recurrent episodes. Testing for serum anti-AQP4 autoantibodies is advised in all patients with severe, atypical or recurrent ON because of the high diagnostic specificity. The diagnostic specificity may be aided by testing for glial biomarkers in the CSF and prognostic accuracy by testing for biomarkers for neuroaxonal degeneration. Optical coherence tomography is a highly accurate tool to document the final outcome. The current clinical classification criteria rely on the phenotype, response to treatment and presence of anti-AQP4 autoantibodies. © 2014 Elsevier B.V.


HALLE (SAALE), Germany,  8 December  2016 - Probiodrug AG (Euronext Amsterdam: PBD), a biopharmaceutical company developing novel therapeutic solutions to treat Alzheimer's disease (AD), announced today that the study design of the ongoing Phase IIa SAPHIR trial comparing PQ912 to placebo will be presented as a poster on Thursday, December 8, 2016 at the  9th Clinical Trials on Alzheimer's disease (CTAD) meeting in San Diego, USA. The SAPHIR study is a 3 month study in treatment naïve patients with early AD. PQ912 targets the inhibition of the Glutaminylcyclase (QC) resulting in a reduction of the production of neurotoxic pyroGlu-Abeta (pGlu-Abeta) and related oligomers. PQ912 has been extensively investigated in Phase 1 Multiple ascending dose studies (MAD) showing good tolerability and a dose dependent QC-inhibition in the spinal fluid. The SAPHIR study has been designed and is conducted in collaboration with Philip Scheltens, M.D., Ph.D., the VUmc Amsterdam (NL) and the CRO Julius Clinical ( NL). The primary objective of the SAPHIR study is to investigate the safety of PQ912 in the target population and the secondary objective is to assess the pharmacodynamic profile. The publication at CTAD reveals that the study applies a series of methodological innovations which in this combination has not been executed before in an early AD study. Specific in and exclusion criteria based on diagnostic biomarkers of Abeta and tau were required to be met by all patients to ensure a high confidence of the diagnosis of early AD. Mini-Mental State Examination (MMSE) and Cogstate test battery assessments at baseline are monitored blindly every 30 patients to ensure consistency and reliability of ratings. A number of exploratory endpoints like EEG, fMRI and a series of CSF based biomarkers including QC-activity, pGlu-Abeta, Abeta oligomers, neurogranin as well as  inflammation markers are centrally analysed. Based on an exploratory analysis of 86 randomised patients, a low standard deviation for the Neuro-psychological test battery and functional EEG at baseline has been observed. Prof Philip Scheltens, Director of the Alzheimer Center at the VUmc  in Amsterdam and Chairman of the SAPHIR study, said: "The combination of in and exclusion criteria together with the primary and innovative exploratory outcome parameter in the SAPHIR study is unique for an early AD study. We are excited to see the full results in the second quarter of 2017." For more information, please contact: Notes to Editors: About Probiodrug AG Headquartered in Halle (Saale), Germany, Probiodrug AG (Euronext Amsterdam: PBD) is a biopharmaceutical company focused on the development of new therapeutic products for the treatment of Alzheimer's disease. Founded in 1997, the company successfully developed a novel therapeutic concept for diabetes - the DP4 inhibitors - which provided the basis for a novel class of antidiabetics - the gliptins. Its core capabilities are based on its long-standing expertise in the elucidation of the structure and function of enzymes involved in the modification of proteins and peptides, which play a central role in pathological conditions. Today Probiodrug's aim is to become a leading company in the development of Alzheimer's disease treatments and to thereby provide a better life for Alzheimer's disease patients. It has identified a new therapeutic concept linked to disease initiation and progression. The development approaches are targeting pyroglutamate-Abeta (pGlu-Abeta) as a therapeutic strategy to fight Alzheimer's disease. The Company has medical use and composition of matter patents related to the inhibition of Glutaminyl Cyclase (QC) and anti-pGlu-Abeta- specific monoclonal antibodies, providing it, in the Company's view, with a leading position in this field of research. Probiodrug's lead product candidate, PQ912, is a highly specific and potent inhibitor of Glutaminyl Cyclase (QC), which has shown therapeutic effects in Alzheimer's animal models. PQ912 is currently in a Phase 2a study, the SAPHIR trial. In a preceding Phase 1 study with healthy young and elderly volunteers, PQ912 has shown to be safe and well tolerated and also revealed high QC-inhibition. About Alzheimer's disease Alzheimer's disease is a neurological disorder, which is the most common form of dementia, and ultimately leads to death. Because Alzheimer's disease cannot be cured and is degenerative, the affected patients must increasingly rely on others for assistance. . Today, 47 million people live with dementia worldwide, and this number is projected to treble to more than 131 million by 2050, as populations age. Dementia also has a huge economic impact. Alzheimer's has an estimated, global societal cost of US$ 818 billion, and it will become a trillion dollar disease by 2018. (World Alzheimer Report 2016). Forward Looking Statements Information set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgment of Probiodrug AG as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.


Jamnitski A.,Jan Van Breemen Research Institute READE | Symmons D.,ARC Epidemiology Unit | Peters M.J.L.,VU University Amsterdam | Sattar N.,University of Glasgow | And 2 more authors.
Annals of the Rheumatic Diseases | Year: 2013

Objective: Data regarding cardiovascular comorbidity and cardiovascular risk factors in patients with psoriatic arthritis (PsA) are limited. To evaluate the cardiovascular risk profile, a systematic literature search was performed to provide an extensive summary of all studies available on cardiovascular risk in PsA. Methods: Medline, EMBASE and the Cochrane library were searched from January 1966 to April 2011 for English language articles on data concerning cardiovascular diseases and cardiovascular risk factors in PsA. Review articles, case reports and studies on psoriasis alone were excluded. Results: Twenty-eight articles were included in this review. Studies on all-cause mortality revealed mixed results. Available data on cardiovascular disease appeared more consistent, indicating an increased cardiovascular mortality and morbidity in PsA. Commensurate with this, surrogate markers of subclinical atherosclerosis, arterial stiffness and cardiovascular risk factors, for example hypertension, dyslipidaemia, obesity and metabolic-related factors, were more prominent in PsA compared with controls. Suppression of inflammation was linked with a favourable effect on cardiovascular surrogate markers, for example carotid intima media thickness and endothelial dysfunction, in several (un) controlled studies. Conclusion: Most studies point towards an increased cardiovascular risk in PsA, broadly on a par with the risk level in rheumatoid arthritis, emphasising the need for similar cardiovascular risk management in both conditions. Further studies are needed to indicate whether inflammatory suppression or modification of traditional cardiovascular risk factors, or both, will reduce cardiovascular risk.


Hypophosphatemia is an important finding in the evaluation of patients with chronic bone pain. Fibroblast-growth factor 23 (FGF23) plays a role in the differential diagnosis of hypophosphatemia. A 34-year-old man had progressive pain in both shoulders and hips due to hypophosphatemic osteomalacia. He had elevated FGF23 levels, induced by a FGF23-producing tumour in the right acetabulum. Thus, he had tumour-induced hypophosphatemic osteomalacia. A 50-year-old man had had bowed legs and joint pains since his youth due to osteomalacia. Several family members also had osteomalacia. His phosphate concentration was low. Genetic testing revealed a mutation on the PHEX gene which results in high FGF23 levels. Thus, he had X-linked hereditary hypophosphatemic osteomalacia. In patients with bone pain, the measurement of a phosphate concentration is important. In renal phosphate loss, the measurement of FGF23 is an important next step if parathormone concentrations are low or normal.


In the Dutch maternity care system women at low risk of complications in pregnancy and birth are distinguished from women at an increased risk. Primary care midwives are responsible for the care in the low-risk group, whereas obstetricians are responsible for care when the risk is increased. Most professionals and stakeholders agree that more continuity of care is warranted but there is no consensus on the ideal organization of care. A midwife-led continuity model of care has been shown to offer several health benefits compared with other models, such as 'shared care'. We argue that this model would be appropriate for the Netherlands. Midwives should provide care where possible and obstetricians where necessary in order to use the expertise of both professions most effectively. This requires an extension of the scope of practice for primary care midwives. This model requires good cooperation between midwives and obstetricians.


Compier A.H.,VUmc
Medical History | Year: 2012

Andreas Vesalius' (1514-64) first publication was a Paraphrasis of the ninth book of the Liber ad Almansorem, written by the Arab-Persian physician and alchemist Rhazes (854-925). The role of Rhazes in Vesalius' oeuvre has thus far been much disregarded. The different ways Rhazes recurs reveal an intellectual evolution in Vesalius' work. In the Paraphrasis, Vesalius subjects Rhazes to the authority of Galen in the context of the early sixteenth-century humanist campaign for the substitution of Arab influences by Greek 'originals'. Over the years Vesalius continues his work on Rhazes, but his approach becomes more internationalistic. Ultimately, Vesalius criticises Galen while expressing sympathy for the Arab author. This may be the more significant as Rhazes could have influenced Vesalius in the act of criticising Galen - critical discussions of Galen were available to Vesalius in Latin translations of Rhazes's Liber Continens. Although Vesalius never refers to the work, it is hardly possible he was unaware of it: similarities in structure, rhetoric and form between the Continens and the De humani corporis fabrica could support this hypothesis. © Abdul Haq Compier, 2012.

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