Press release
Fulcrum Therapeutics® Announces REACH, a Phase 3 Clinical Trial of Losmapimod in Facioscapulohumeral Muscular Dystrophy (FSHD)
Reachable Workspace (RWS) primary endpoint based on discussions with FDA and EU regulatory agencies Trial expected to begin in 2Q 2022Potential
About this update from Fulcrum Therapeutics, Inc.
[{"type":"text","content":"Reachable Workspace (RWS) primary endpoint based on discussions with FDA and EU regulatory agencies Trial expected to begin in 2Q 2022Potential first-to-market therapy for FSHDFulcrum to host virtual Key Opinion Leader webcast on FSHD on March 24 at 10:00am ET CAMBRIDGE, Mass., March 03, 2022 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced its plans to initiate REACH, a Phase 3 clinical trial of losmapimod in people with facioscapulohumeral muscular dystrophy (FSHD), in the second quarter of 2022. FSHD is a serious, rare, progressive and debilitating disease for which there are no approved treatments. It is characterized by fat infiltration of skeletal muscle leading to muscular atrophy involving the face, scapula and shoulders, upper arms, and abdomen. Impact on patients includes profound decreases in the ability to perform activities of daily living, loss of upper limb function, loss of mobility and independence, and chronic pain. “We are excited to advance losmapimod into the REACH Phase 3 trial for FSHD,” said Bryan Stuart, Fulcrum’s president and chief executive officer. “Results from the Phase 2b clinical trial demonstrated that losmapimod slowed disease progression and improved function in people with FSHD. Based on these data as well as insights gained from the trial on optimal measures of disease progression, we aligned with regulators, including the FDA, on key aspects of the design of the REACH trial. With positive data, we expect REACH to be the basis for approval. This marks a significant milestone for FSHD patients and caregivers, and Fulcrum remains committed to serving the FSHD community.” “There are no approved therapies for FSHD, and there is a clear and urgent need for a treatment to slow or stop disease progression,” said Nicholas Johnson, MD, M.Sci., FAAN, associate professor, division chief of neuromuscular, and vice chair of research in the department of neurology at Virginia Commonwealth University. “For people with FSHD, every day without a treatment is another day that they may lose strength, the ability to lift their arms, or walk unassisted. Losmapimod is the first and only investigational medicine in clinical development. The data to date are ver...