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)
| SEATTLE, Nov. 19, 2019 /PRNewswire/ -- 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 About FDY-5301 About Faraday Contact: Julie Rathbun
SOURCE Faraday Pharmaceuticals |
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