Faraday Pharmaceuticals Announces Completion of Enrollment in Pivotal Phase 3 Iocyte AMI-3 Trial of FDY-5301

2024-06-11

临床2期临床3期临床结果

2,300 patients in trial enrolled ahead of schedule

12-month follow up period underway, with topline data anticipated in 2H 2025

Trial designed with 90% power to detect a 30% reduction in the primary outcome of heart failure and cardiovascular death after anterior STEMI

SEATTLE, June 11, 2024 (GLOBE NEWSWIRE) -- Faraday Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on the prevention of heart failure by reducing myocardial damage following acute ST-elevation myocardial infarction (STEMI) through the reduction of reperfusion injury during percutaneous coronary intervention (PCI), today announced completion of enrollment in its ongoing pivotal Phase 3 Iocyte AMI-3 trial of FDY-5301. Topline data is expected to be available in the second half of 2025. If positive, the results are expected to serve as the foundation for a New Drug Application submission to the U.S. Food and Drug Administration (FDA) and other drug regulatory agencies.

“We are delighted to announce this important milestone for the Phase 3 trial of FDY-5301. It is a credit to the entire Faraday team, our partners at Medpace, as well as our dedicated steering, data monitoring, and event adjudication committees and our exceptional clinical investigators and their site staff,” said Dr. Stephen A. Hill, Chief Executive Officer of Faraday. “We are very pleased to remain on track for a data read-out next year with hopes of improving the clinical outcomes for patients following acute myocardial infarction.”

After a recent, planned interim analysis of safety and efficacy data from over 1,500 patients followed up for at least 28 days, the trial’s independent data monitoring committee recommended completing the trial without modification.

The Iocyte AMI-3 trial is a randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of FDY-5301 in reducing cardiovascular death and heart failure events in anterior STEMI patients undergoing PCI. The trial is being conducted in over 130 sites across North America, Europe, and Israel. The 2,300 subjects enrolled in the trial were recruited between May 2022 and June 2024. After receiving a single bolus dose of FDY-5301 or placebo shortly before PCI, all patients are followed up for 12 months. The trial is being conducted under a Special Protocol Assessment agreement reached with the FDA. For more information on the Iocyte AMI-3 trial, please visit ClinicalTrials.gov and reference Identifier NCT04837001.

About STEMI

Acute STEMI is a leading cause of cardiovascular death and remains a primary cause of the development of heart failure. Standard treatment of a STEMI involves PCI, during which a catheter is inserted into the artery to remove the blockage and restore blood flow. Following a STEMI, one of the critical factors influencing patient outcomes is reperfusion injury, which occurs when the oxygen-rich blood supply returns to the ischemic heart muscle.

About FDY-5301

FDY-5301 is an elemental reducing agent containing sodium iodide for which Faraday has obtained method of use patent protection in major markets worldwide. Faraday has selected FDY-5301 for investigation in the belief that its properties are uniquely well-suited to mitigate ischemia-reperfusion injury (IRI). In preclinical IRI models, FDY-5301 reduced tissue damage, infarct size, and inflammation. FDY-5301 functions as a catalytic neutralizer of hydrogen peroxide, a prominent reactive oxygen species implicated in the IRI cascade leading to cardiomyocyte death, and also acts as an immunomodulating agent. A Phase 2 clinical trial of FDY-5301 in STEMI patients demonstrated that it 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.

About Faraday Pharmaceuticals, Inc.

Faraday Pharmaceuticals® is a clinical-stage biopharmaceutical company focused on the prevention of heart failure by reducing myocardial damage in acute STEMI. The company was founded by Dr. Mark Roth of the Fred Hutch Cancer Center Cancer Center and is backed by an investor group led by ARCH Venture Partners and Polaris Partners. The company’s lead program, FDY-5301, is in a pivotal Phase 3 trial and is designed to reduce IRI in acute STEMI, a leading cause of death and a primary cause of the development of heart failure. The company is headquartered in Seattle. For more information, visit www.faradaypharma.com or follow the company on LinkedIn.

Contact:

Brian Blackman

Chief Financial Officer

bblackman@faradaypharma.com

PJ Kelleher

LifeSci Advisors, LLC

+1-617-430-7579

pkelleher@lifesciadvisors.com