SPA Agreement Reached with FDA on Protocol Design and Statistical Approach for Phase 3 FDY-5301 Cardiovascular Outcomes Trial
SEATTLE, WA / ACCESSWIRE / March 25, 2021 / Faraday Pharmaceuticals, Inc., a muscle health-focused biopharmaceutical company developing therapeutics to treat patients experiencing potentially life changing critical illness, announced today it has reached agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) on the protocol design and statistical analysis approach to be taken in Faraday's Phase 3 cardiovascular outcomes study evaluating FDY-5301 for the treatment of acute ST-segment elevation myocardial infarction (STEMI) in patients undergoing percutaneous intervention (PCI).
"Receipt of this SPA agreement is a major milestone achievement that provides Faraday with a clearly defined development and regulatory pathway for FDY-5301 in the treatment of reperfusion injury post AMI," said Steve Hill, Faraday's Chief Executive Officer. "We would like to thank the FDA for its engagement and guidance in this process."
Faraday intends to conduct a single, randomized, double-blind, placebo-controlled Phase 3 study of intravenous FDY-5301 in patients with an anterior STEMI. The study is powered to show a 30% relative reduction in cardiovascular (CV) death and heart failure with a two-sided p-value of less than 0.05, which, if successful, would support a regulatory submission for marketing approval. Demonstrating a 30% relative reduction in CV death and heart failure in anterior STEMIs could form the basis of a generalizable label for all STEMI patients undergoing primary PCI. The company plans to initiate the study in the second half of 2021.
About Special Protocol Assessment (SPA)
The SPA process is one in which sponsors may ask the FDA to evaluate the proposed design of Phase 3 clinical trials that are intended to form the primary basis for determining a drug product's efficacy and approvability. A SPA agreement indicates concurrence by FDA with the adequacy and acceptability of specific critical elements of protocol design and analysis. Additionally, it provides an agreement with the FDA's review division with respect to the elements agreed to in the SPA process that are considered critical to ensuring the trial has the potential to support a future marketing application. However, final marketing approval depends upon the results of efficacy, the safety profile, and an evaluation of the risk/benefit of the treatment demonstrated in the Phase 3 clinical trial, among other requirements, and the FDA may revoke or alter its agreement under certain circumstances. For further information regarding the SPA process, please visit the FDA website at www.fda.gov.
About STEMI and Reperfusion Injury
An estimated 810,000 Americans will suffer a heart attack in 2021. An ST-segment elevation myocardial infarction (STEMI) is a 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. Standard treatment of STEMI involves Percutaneous Coronary Intervention (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 damage contributes a significant portion of the total cardiac muscle damage suffered as a result of a heart attack, and it is the one part of the treatment of a heart attack that has not been addressed by drug interventions.
FDY-5301 is a patented elemental reducing agent containing sodium iodide. It works 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 demonstrate no signs of toxicity in healthy subjects, and Phase 2 data suggest a reduction in infarct size and improved cardiac function in patients treated with FDY-5301 after suffering an acute myocardial infarction (AMI).
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 in patients experiencing a potentially life changing critical illness. For more information, visit www.faradaypharma.com.
SOURCE: Faraday Pharmaceuticals, Inc
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