|Faraday Pharmaceuticals Announces First Patient Enrolled in Phase 2 Study for ICU-Acquired Weakness|
|By: GlobenewsWire - 14 Oct 2021||Back to overview list
Expands the potential therapeutic use of FDY-5301
SEATTLE, Oct. 14, 2021 (GLOBE NEWSWIRE) -- Faraday Pharmaceuticals, Inc., a biopharmaceutical company dedicated to improving the quality of life for patients experiencing potentially life-changing critical illness by focusing on muscle health, today announced the enrollment of its first patient in a Phase 2 study of FDY-5301 (“Iocyte ICU”). FDY-5301 is an elemental reducing agent being developed by the company for the prevention and treatment of ICU-acquired weakness (ICUAW) and other muscle related conditions.
“We are excited to advance the clinical development of FDY-5301 in ICUAW, a second potential indication for this product candidate,” commented Dr. Stephen A. Hill, CEO of Faraday. He added that, “We believe FDY-5301 has the potential to be the first approved medical option for preventing or treating secondary organ injury, including muscle wasting, for trauma patients in the ICU. This study is an important step as we expand our targets for maintaining muscle health beyond the prevention of heart muscle injury after acute myocardial infarction.”
Iocyte ICU is designed to evaluate the efficacy, pharmacokinetics, and safety of FDY-5301 in major trauma patients admitted to the ICU where the need for ventilation is anticipated. The study is evaluating two dose levels of FDY-5301 (1 mg/kg or 2 mg/kg) compared to placebo. Using co-primary endpoints of the Chelsea Critical Care Physical Assessment Tool (CPAx) score and overall time to organ recovery, the study will assess the effect of FDY-5301 on muscle function and organ dysfunction.
About ICU-Acquired Weakness
ICU-acquired weakness (ICUAW) is a condition characterized by peripheral muscle weakness and wasting affecting ICU patients. It is estimated 825,000 patients in the U.S. will be admitted to the ICU with a traumatic injury in 2021. Many of those patients will lose significant muscle function and mass, independent of the trauma that put them into the ICU, and many will endure a high degree of organ failure during their stay. Acute muscle loss often becomes a chronic disabling problem, leading to diminished quality of life after release from the ICU (ICUAW or Post-ICU syndrome).
FDY-5301 is an elemental reducing agent containing sodium iodide for which Faraday has obtained method of use patent protection. 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 have demonstrated no signs of toxicity in healthy subjects, and a Phase 2 study suggested a reduction in infarct size and improved cardiac function in patients treated with FDY-5301 after suffering an acute myocardial infarction (AMI).
About Faraday Pharmaceuticals, Inc.
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 addition to starting the Iocyte ICU study, the Faraday team has progressed FDY-5301 from IND to Phase 3-ready in reperfusion injury associated with AMI.
For more information, visit www.faradaypharma.com.
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