Faraday Pharmaceuticals, Inc. today announced its agreement with the Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) amendment, enabling the company to expedite its planned Phase 3 study interim analysis.
- Interim analysis estimated to occur in late Q2 2024 and will be based on at least 50% of anticipated primary outcomes
- Pivotal Phase 3 trial continues to progress with over 75% of initially-planned patients enrolled
- European Patent Office notice allows for expansion of FDY-5301 patent protection into the EU
SEATTLE, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Faraday Pharmaceuticals Inc., a clinical-stage biopharmaceutical company focused on the prevention of heart failure by reducing myocardial damage in acute ST-elevation myocardial infarction (STEMI) through the treatment of reperfusion injury, today announced its agreement with the Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) amendment, enabling the company to expedite its planned Phase 3 study interim analysis. The company also announced its receipt of a notice of “intention to grant” its FDY-5301 patent application from the European Patent Office (EPO), allowing for the expansion of FDY-5301’s protection across the European Union (EU) into 2035.
The SPA amendment optimizes the timing, based on the study’s current enrollment rate, and expands the data set of the interim analysis. The interim analysis covers at least 50% of the study’s anticipated primary outcomes and enables the company to potentially upsize the study’s enrollment to increase the likelihood of meeting its primary endpoints. In addition, once Faraday’s European patent application (no. 15746855.4, entitled Halogen Treatment of Heart Attack and Ischemic Injury) is officially granted and validated, the company will have achieved its goal of securing FDY-5301 patent protection in major markets worldwide.
“We are grateful for the FDA’s continued support and guidance and pleased to have its written agreement on our expedited interim analysis for the pivotal Phase 3 trial of FDY-5301,” said Dr. Stephen A. Hill, Chief Executive Officer of Faraday. “The interim analysis is now expected four to six months sooner than previously planned, and if our data monitoring committee recommends upsizing the study, we will gain a meaningful range of statistically supported probabilities of success by doing so.”
Dr. Hill continued: “In addition, the European patent grant will enhance the commercial potential of FDY-5301. We look forward to completing our Phase 3 study enrollment and potentially bringing FDY-5301 forward as the first therapy for reducing post-STEMI ischemia-reperfusion injury.”
The ongoing Phase 3 IOCYTE AMI-3 study is a randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of FDY-5301 in reducing cardiovascular (CV) death and heart failure events in anterior STEMI patients undergoing primary percutaneous intervention (PCI). Unless upsized based on the interim analysis, the study plans to enroll approximately 2,300 anterior STEMI patients across 150 centers in North America, Europe, and Israel. The trial is being conducted under a Special Protocol Agreement reached with the U.S. Food and Drug Administration. For more information on the IOCYTE AMI-3 Phase 3 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 episode, one of the critical factors influencing patient outcome is reperfusion injury which occurs when the oxygen-rich blood supply returns to the ischemic area.
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. FDY-5301’s unique properties are 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 treating IRI 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.
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 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 ischemia-reperfusion injury 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
