Faraday Pharmaceuticals Completes Enrollment for Phase 3 Iocyte AMI-3 Trial of FDY-5301

Faraday Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, has announced the successful enrollment of 2,300 patients in its pivotal Phase 3 Iocyte AMI-3 trial ahead of schedule. The trial is focused on evaluating the efficacy of their lead product, FDY-5301, designed to prevent heart failure by reducing myocardial damage following an acute ST-elevation myocardial infarction (STEMI). This achievement comes as the company plans to follow up with patients for 12 months, with topline data expected in the latter half of 2025.

Dr. Stephen A. Hill, the Chief Executive Officer of Faraday, expressed his satisfaction with the milestone, attributing the success to the dedicated Faraday team, partners at Medpace, various committees involved in trial monitoring, and the clinical investigators and site staff. He emphasized the importance of the trial data, which could potentially improve clinical outcomes for patients suffering from acute myocardial infarction.

The Iocyte AMI-3 trial involves a randomized, double-blind, placebo-controlled design to assess the safety and efficacy of FDY-5301 in reducing cardiovascular death and heart failure events among anterior STEMI patients undergoing percutaneous coronary intervention (PCI). Conducted across more than 130 sites in North America, Europe, and Israel, the trial enrolled patients between May 2022 and June 2024. Each participant received either a single bolus dose of FDY-5301 or a placebo before PCI, followed by a 12-month monitoring period.

Following a planned interim analysis of safety and efficacy data from over 1,500 patients who had been observed for at least 28 days, an independent data monitoring committee recommended the trial proceed without any modifications. This decision underscores the potential of FDY-5301 to achieve its intended outcomes.

FDY-5301 is an elemental reducing agent containing sodium iodide and is under patent protection in major markets globally. The compound was chosen for its unique properties that are believed to mitigate ischemia-reperfusion injury (IRI), which occurs when blood supply returns to the ischemic heart muscle, causing damage. In preclinical models, FDY-5301 demonstrated a reduction in tissue damage, infarct size, and inflammation. Its mechanism involves neutralizing hydrogen peroxide, a reactive oxygen species implicated in the IRI cascade, and acting as an immunomodulating agent. A Phase 2 trial of FDY-5301 in STEMI patients showed it was well-tolerated and suggested potential efficacy in minimizing cardiac damage.

If the results of the Phase 3 trial are positive, Faraday Pharmaceuticals intends to use the data as the basis for a New Drug Application submission to the U.S. Food and Drug Administration (FDA) and other regulatory bodies.

Faraday Pharmaceuticals was founded by Dr. Mark Roth from the Fred Hutch Cancer Center and is financially supported by ARCH Venture Partners and Polaris Partners. The company’s primary focus is on developing treatments to prevent heart failure by addressing myocardial damage in acute STEMI. Faraday’s headquarters are located in Seattle. 

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