May 10, 2022 — Faraday Pharmaceuticals, Inc., today announced the enrollment of the first patient in its Iocyte AMI-3 study — a Phase 3 clinical trial assessing the efficacy and safety of FDY-5301 in reducing cardiovascular (CV) death and heart failure in anterior ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous intervention (PCI). The trial is being conducted under a Special Protocol Agreement reached with the U.S. Food and Drug Administration.
“We are pleased to enroll our first patient in the Iocyte AMI-3 trial, which will further our understanding of the potential role of FDY-5301 in improving health outcomes for anterior STEMI patients,” said Dr. Stephen A. Hill, CEO of Faraday. “This trial is a testament to Faraday’s commitment to finding innovative solutions to unmet needs that may enable patients to live longer, better lives.”
Deepak L. Bhatt, MD, MPH, chair of the study’s Steering Committee, Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Health, and Professor of Medicine at Harvard Medical School, said, “There are no effective drug therapies for reducing ischemia-reperfusion injury in STEMI patients undergoing PCI. This study has the potential to show FDY-5301 could be such a therapy and reduce poor outcomes after a STEMI, such as heart failure.”
The global, randomized, double-blind, placebo-controlled Phase 3 study of intravenous FDY-5301 is targeted to enroll approximately 2,300 anterior STEMI patients across 150 centers in North America, Europe, and Israel. The study, if successful, would support a regulatory submission for marketing approval. Further, demonstrating a sufficient relative reduction in CV death and heart failure in anterior STEMIs could form the basis of a generalizable product label for all STEMI patients undergoing PCI.
For more information: www.faradaypharma.com