FDY-5301

SEATTLE, July 16, 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 it will host a virtual KOL webinar on Tuesday, July 30, 2024, at 11:00 AM ET. To register for the webinar, click here. The webinar will feature Dr. Cheerag Shirodaria (Oxford University Hospitals), Dr. Marc Bonaca (University of Colorado Anschutz), and Dr. Antonio Gutierrez (Duke University Hospital and Durham VA Medical Center), who will discuss the unmet need and current treatment landscape in preventing ischemia-reperfusion injury and highlight the effects of STEMI on heart failure and other patient outcomes. The webinar will also review data from the development of FDY-5301, an investigational product being evaluated by Faraday in minimizing cardiac damage following acute STEMI. The company’s pivotal Phase 3 Iocyte AMI-3 trial of FDY-5301 in anterior STEMI patients undergoing primary percutaneous intervention is now fully enrolled with topline data anticipated in 2H 2025. A live question and answer session will follow the formal presentations. About Cheerag Shirodaria, BSc, MBBS, MD, FRCP, MBA Dr. Cheerag Shirodaria is Chief Development Officer at Caristo Diagnostics and a Cardiologist at Oxford University Hospitals in the UK. He is an interventional cardiologist who is also an expert in cardiac imaging, particularly cardiac MRI (CMR) and coronary CT angiography (CCTA), having completed his doctoral thesis in Oxford on novel vascular imaging techniques using CMR. He was heavily involved in the design and execution of the phase 2 STEMI trial involving FDY-5301 and is a member of the Executive Steering Committee of the IOCYTE-AMI trial. As co-founder and former CEO of Caristo, he has developed and commercialized novel imaging AI imaging tools to predict future cardiometabolic risk. Dr Shirodaria obtained his medical degree from St Bartholomew's Hospital Medical College, his medical doctorate from the University of Oxford and his MBA from London Business School. About Marc Bonaca, MD, MPH Dr. Marc Bonaca is a cardiologist and vascular medicine specialist serving as executive director of CPC and Director of Vascular Research & Professor of Medicine at the University of Colorado Anschutz. Dr. Bonaca earned his medical degree from the University of Connecticut and his MPH at Harvard. He completed his medical residency, cardiology fellowship, and vascular medicine fellowship at Brigham and Women’s Hospital and a dedicated research fellowship at the TIMI Study Group. He became faculty at BWH and Harvard Medical School and an investigator at TIMI. He directed pharmacovigilance at TIMI and was an investigator on several large outcomes trials including TRA2P-TIMI 50, PEGASUS-TIMI 54, DECLARE-TIMI 58, and REAL TIMI 63B. In 2018, he joined the faculty at the University of Colorado as Professor of Medicine and the William R. Hiatt Endowed Chair in Cardiovascular Research. He is the Executive Director of CPC, an affiliated non-profit Academic Research Organization. At CPC, he has led several clinical trials with CPC as the lead ARO, including VOYAGER PAD, PREVENT HD, and ASPEN, and is leading several ongoing trials, including BRIGHT and EVOLVE MI, a 4000-patient pragmatic multinational acute coronary syndrome trial. Dr. Bonaca’s research focus is on ischemic risk with atherosclerotic vascular disease, risk prediction, and risk modification using pharmacologic and biologic therapies. He has extensive experience designing and conducting large, multicenter randomized clinical trials, and analyzing registries and real-world datasets. His areas of interest include PAD, PVD, and diabetes, with a focus on the breadth of risk including ischemic limb outcomes, microvascular complications, and major adverse cardiovascular events. He is also investigating the cardiac, vascular, and thrombotic complications associated with novel oncologic therapies. At CPC, he has focused on building a robust faculty and operational group dedicated to high quality, efficient trials leveraging health networks, informatics, and decentralized design. About J. Antonio T. Gutierrez, MD Dr. Antonio Gutierrez’s clinical interests include diagnostic and interventional coronary angiography, peripheral angiography and percutaneous intervention, and vascular medicine. His research interests are focused on peripheral artery disease. He has been involved in multiple clinical trials involving patients with atherosclerotic disease and has published several peer-reviewed articles and reviews. Dr. Gutierrez received his Bachelor of Arts from the College of the Holy Cross in 2000, Doctorate of Medicine from Case Western Reserve University School of Medicine in 2007, and Masters of Health Science in Clinical Research from Duke University School of Medicine in 2012. He completed his residency in Internal Medicine at Duke University Medical Center in 2010 and was appointed Chief Medical Resident of the Durham VA Medical Center in 2011. Dr. Gutierrez completed his General Cardiology and Vascular Medicine Fellowships at Brigham and Women’s Hospital and a Clinical Research Fellowship at the TIMI Study Group. Most recently Dr. Gutierrez matriculated his Interventional Cardiology Fellowship at Duke University Medical Center. Dr. Gutierrez is currently an Assistant Professor of Medicine at Duke University Hospital and Staff Physician at the Durham VA Medical Center. 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 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 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 BlackmanChief Financial Officerbblackman@faradaypharma.com Contact:PJ KelleherLifeSci Advisors, LLC+1-617-430-7579pkelleher@lifesciadvisors.com

2,300 patients in trial enrolled ahead of schedule12-month follow up period underway, with topline data anticipated in 2H 2025Trial 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-5301FDY-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 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 BlackmanChief Financial Officerbblackman@faradaypharma.com PJ KelleherLifeSci Advisors, LLC+1-617-430-7579pkelleher@lifesciadvisors.com