Treatment well tolerated, with encouraging signs to support pivotal trial
Results presented at American Heart Association Scientific Sessions 2019
SEATTLE, WA, USA I November 19, 2019 I Faraday Pharmaceuticals, a biopharmaceutical company focused on the development of small molecules for critical care medicine, today announced top-line results from its Phase 2 trial of FDY-5301 for the treatment of reperfusion injury following ST elevation myocardial infarction (STEMI). These data demonstrated that the treatment was well tolerated, with encouraging signals of efficacy in reducing cardiac damage. Results were presented in an oral presentation at the American Heart Association (AHA) Scientific Sessions 2019.
In the Phase 2 IOCYTE AMI Study, 120 patients were randomized to receive placebo, or FDY-5301 (0.5mg/kg, 1.0 mg/kg or 2.0 mg/kg), administered intravenously as a single-dose treatment prior to reperfusion therapy with percutaneous coronary intervention (PCI) for acute STEMI. Outcome measures included 14-day arrhythmia monitoring and magnetic resonance imaging (MRI) of infarct size and cardiac function at 3 months post-treatment.
Results show that treatment with FDY-5301 was well tolerated, with no evidence of increased risk of clinically significant arrhythmias at doses up to 2 mg/kg. In addition, at higher dose levels, encouraging signs of efficacy were observed. Median infarct size (as a proportion of left ventricle) in the 2mg/kg FDY-5301 group was 8.5% compared to 14.9% on placebo. Median left ventricular ejection fraction was 53.9% on placebo compared to 63.2% on 2mg/kg FDY-5301. As the study was not powered for these secondary efficacy outcomes, these improvements did not reach statistical significance.
“These results demonstrate that FDY-5301 was well tolerated and we were able to achieve therapeutic levels of drug in plasma, very rapidly and prior to reperfusion, in the setting of the emergency PCI procedure. The data are encouraging and support further evaluation in a larger scale clinical trial,” said Keith M. Channon, M.D., lead investigator and Professor of Cardiovascular Medicine, University of Oxford. “Our goal in treating STEMI patients is to reduce infarct size and thus improve our patients’ prognoses. Minimizing the contribution to infarct size from reperfusion injury, as may be possible with agents such as FDY-5301, would have an important impact on a patient’s quality of life following a heart attack.”
“We are encouraged by these results and look forward to advancing FDY-5301 into a pivotal Phase 3 trial for the treatment of reperfusion injury,” said Stephen Hill, M.D. “There are currently no convenient drug treatment options for reperfusion injury following PCI. As such, FDY-5301 may hold promise as a novel, first-generation therapy.”
About STEMI and Reperfusion Injury
ST-segment elevation myocardial infarction (STEMI) is a serious heart attack that occurs when a coronary artery is blocked and results in a lack of blood flow to an area of heart muscle, causing a shortage of oxygen and resulting in tissue damage. Standard treatment of STEMI involves Percutaneous Coronary Intervention (PCI) during which a catheter is used to reopen the blocked artery and restore blood flow. Reperfusion injury – or reoxygenation injury – is tissue damage that occurs once blood supply is returned to oxygen-starved tissue.
About FDY-5301
FDY-5301 is a patented, formulated, elemental reducing agent containing sodium iodide. It works to catalytically destroy hydrogen peroxide, which is naturally generated as a response to acute ischemia-reperfusion injury and contributes to loss of muscle mass and function. Preclinical studies of FDY-5301 have demonstrated its ability to reduce infarct size, improve cardiac function, and improve skeletal muscle function. Phase 1 data has demonstrated no signs of toxicity in healthy subjects.
About Faraday
Faraday Pharmaceuticals is a biopharmaceutical company focused on improving outcomes of critical care illnesses by reducing the loss of cardiac and skeletal muscle function. The company is headquartered in Seattle. For more information, visit www.faradaypharma.com.
SOURCE: Faraday Pharmaceuticals
Post Views: 28
Treatment well tolerated, with encouraging signs to support pivotal trial
Results presented at American Heart Association Scientific Sessions 2019
SEATTLE, WA, USA I November 19, 2019 I Faraday Pharmaceuticals, a biopharmaceutical company focused on the development of small molecules for critical care medicine, today announced top-line results from its Phase 2 trial of FDY-5301 for the treatment of reperfusion injury following ST elevation myocardial infarction (STEMI). These data demonstrated that the treatment was well tolerated, with encouraging signals of efficacy in reducing cardiac damage. Results were presented in an oral presentation at the American Heart Association (AHA) Scientific Sessions 2019.
In the Phase 2 IOCYTE AMI Study, 120 patients were randomized to receive placebo, or FDY-5301 (0.5mg/kg, 1.0 mg/kg or 2.0 mg/kg), administered intravenously as a single-dose treatment prior to reperfusion therapy with percutaneous coronary intervention (PCI) for acute STEMI. Outcome measures included 14-day arrhythmia monitoring and magnetic resonance imaging (MRI) of infarct size and cardiac function at 3 months post-treatment.
Results show that treatment with FDY-5301 was well tolerated, with no evidence of increased risk of clinically significant arrhythmias at doses up to 2 mg/kg. In addition, at higher dose levels, encouraging signs of efficacy were observed. Median infarct size (as a proportion of left ventricle) in the 2mg/kg FDY-5301 group was 8.5% compared to 14.9% on placebo. Median left ventricular ejection fraction was 53.9% on placebo compared to 63.2% on 2mg/kg FDY-5301. As the study was not powered for these secondary efficacy outcomes, these improvements did not reach statistical significance.
“These results demonstrate that FDY-5301 was well tolerated and we were able to achieve therapeutic levels of drug in plasma, very rapidly and prior to reperfusion, in the setting of the emergency PCI procedure. The data are encouraging and support further evaluation in a larger scale clinical trial,” said Keith M. Channon, M.D., lead investigator and Professor of Cardiovascular Medicine, University of Oxford. “Our goal in treating STEMI patients is to reduce infarct size and thus improve our patients’ prognoses. Minimizing the contribution to infarct size from reperfusion injury, as may be possible with agents such as FDY-5301, would have an important impact on a patient’s quality of life following a heart attack.”
“We are encouraged by these results and look forward to advancing FDY-5301 into a pivotal Phase 3 trial for the treatment of reperfusion injury,” said Stephen Hill, M.D. “There are currently no convenient drug treatment options for reperfusion injury following PCI. As such, FDY-5301 may hold promise as a novel, first-generation therapy.”
About STEMI and Reperfusion Injury
ST-segment elevation myocardial infarction (STEMI) is a serious heart attack that occurs when a coronary artery is blocked and results in a lack of blood flow to an area of heart muscle, causing a shortage of oxygen and resulting in tissue damage. Standard treatment of STEMI involves Percutaneous Coronary Intervention (PCI) during which a catheter is used to reopen the blocked artery and restore blood flow. Reperfusion injury – or reoxygenation injury – is tissue damage that occurs once blood supply is returned to oxygen-starved tissue.
About FDY-5301
FDY-5301 is a patented, formulated, elemental reducing agent containing sodium iodide. It works to catalytically destroy hydrogen peroxide, which is naturally generated as a response to acute ischemia-reperfusion injury and contributes to loss of muscle mass and function. Preclinical studies of FDY-5301 have demonstrated its ability to reduce infarct size, improve cardiac function, and improve skeletal muscle function. Phase 1 data has demonstrated no signs of toxicity in healthy subjects.
About Faraday
Faraday Pharmaceuticals is a biopharmaceutical company focused on improving outcomes of critical care illnesses by reducing the loss of cardiac and skeletal muscle function. The company is headquartered in Seattle. For more information, visit www.faradaypharma.com.
SOURCE: Faraday Pharmaceuticals
Post Views: 28
