News | STEMI | May 10, 2022

Faraday Pharmaceuticals Announces First Patient Enrolled in Phase 3 Trial for Myocardial Infarction

Iocyte AMI-3 Trial to assess effectiveness and safety of FDY-5301 in improving outcomes for anterior STEMI patients undergoing primary PCI

Iocyte AMI-3 Trial to assess effectiveness and safety of FDY-5301 in improving outcomes for anterior STEMI patients undergoing primary PCI

Getty Images


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.

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, 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


Related Content

News | Heart Failure

June 7, 2024 — Calcific aortic valve disease (CAVD) is the major heart valve disease that afflicts nearly 10 million ...

Home June 07, 2024
Home
News | Heart Failure

June 7, 2024 — BioCardia, Inc., a company focused on cellular and cell-derived therapeutics for the treatment of ...

Home June 07, 2024
Home
News | Heart Failure

May 28, 2024 — Yoga focused on breathing, meditation, and relaxation is linked with symptom improvement in patients with ...

Home May 28, 2024
Home
News | Heart Failure

May 22, 2024 — New research from The Cooper Institute and partners at University of Texas (UT) Southwestern Medical ...

Home May 22, 2024
Home
News | Heart Failure

April 30, 2024 — A multicenter study led by Vanderbilt University Medical Center (VUMC) and Lipscomb University College ...

Home April 30, 2024
Home
News | Heart Failure

April 16, 2024 — Each year more than 500,000 Americans undergo percutaneous coronary intervention, or PCI, a minimally ...

Home April 16, 2024
Home
News | Heart Failure

April 12, 2024 — University of Virginia School of Medicine researchers have discovered a gene on the Y chromosome that ...

Home April 12, 2024
Home
News | Heart Failure

April 2, 2024 — People who use e-cigarettes are significantly more likely to develop heart failure compared with those ...

Home April 02, 2024
Home
News | Heart Failure

March 29, 2024 — V-Wave announced it will present late-breaking data from its RELIEVE-HF pivotal trial at the American ...

Home March 29, 2024
Home
News | Heart Failure

March 25, 2024 — A team of engineers led by the University of Massachusetts Amherst and including colleagues from the ...

Home March 25, 2024
Home
Subscribe Now