Faraday Pharmaceuticals Announces First Patient Enrolled in Phase 3 Trial for Myocardial Infarction
Faraday Pharmaceuticals, Inc. recently 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 US FDA. The first patient was enrolled by Dr. Jay Traverse, interventional cardiologist, and Jo Anne Goldman, at the Minneapolis Heart Institute Foundation in Minneapolis, MN.
“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, added “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.
The American Heart Association estimates over 800,000 Americans suffer a heart attack every year. A STEMI is a type of heart attack that occurs when a coronary artery is blocked, stopping blood flow to an area of the heart. This area becomes ischemic due to lack of oxygen and requires immediate treatment to minimize the amount of damage caused. Acute STEMI is a leading cause of CV death and remains the primary cause for the development of heart failure. Heart failure is a cause of significant morbidity and mortality in the United States and is a major and growing contributor to the country’s overall medical cost burden.1 Standard treatment of a STEMI involves PCI, during which a catheter is inserted into the artery to remove the blockage and restore blood flow. Reperfusion injury is the damage done when the oxygen-rich blood supply returns to the ischemic area. This injury represents a significant portion of the total cardiac muscle damage suffered from a heart attack and is the one aspect of treating of a heart attack that has not been addressed by drug interventions.
FDY-5301 is an elemental reducing agent containing sodium iodide for which Faraday has obtained method-of-use patent protection in major markets worldwide. Sodium iodide has been observed to have various physiological effects on the body, including on the heart. For example, it has been shown to catalytically destroy hydrogen peroxide, which is generated as a response to acute injury and contributes to loss of muscle mass and function. Preclinical studies of FDY-5301 have demonstrated its ability to reduce cardiac and skeletal muscle injury. Phase 1 data have demonstrated no signs of toxicity in healthy subjects. A Phase 2 trial of FDY-5301 in treating reperfusion injury following a STEMI demonstrated the treatment was well-tolerated and provided encouraging signals of potential efficacy in minimizing cardiac damage. Results from that trial — known as Iocyte AMI — were reported in the January 15, 2022, issue of the International Journal of Cardiology.
Faraday Pharmaceuticals is a Seattle-based biopharmaceutical company founded by Dr. Mark Roth of the Fred Hutchinson Cancer Research Center and backed by an investor group led by ARCH Venture Partners and Polaris Partners. With a clinically and commercially experienced senior leadership team, the company is focused on treating and preventing muscle injury. For more information, visit www.faradaypharma.com.
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