Press release
Fulcrum Therapeutics Announces Recent Business Highlights and Financial Results for Third Quarter 2023
― Completed enrollment in the Phase 3 REACH trial of losmapimod in facioscapulohumeral muscular dystrophy (FSHD); expect to report topline data in the fourth
About this update from Fulcrum Therapeutics, Inc.
[{"type":"text","content":"― Completed enrollment in the Phase 3 REACH trial of losmapimod in facioscapulohumeral muscular dystrophy (FSHD); expect to report topline data in the fourth quarter of 2024 ― ― U.S. Food and Drug Administration (FDA) lifted clinical hold for pociredir (formerly FTX-6058) in sickle cell disease (SCD); trial reinitiation underway ― ― Cash runway extended into 2026 ― ― Conference call and webcast scheduled for 8:00 a.m. ET today ― CAMBRIDGE, Mass., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (“Fulcrum”) (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases, today reported financial results for the third quarter of 2023 and provided a business update. “In the third quarter of 2023, we completed enrollment for the Phase 3 REACH trial of losmapimod and resolved the clinical hold for pociredir, bringing us one step closer to delivering on our mission to improve the lives of patients with rare genetic diseases,” said Alex C. Sapir, Fulcrum’s president and chief executive officer. “Building on this momentum, we remain focused on strong execution and believe we are now well-positioned to deliver on important clinical milestones, including topline data for REACH, which is expected in the fourth quarter of 2024. REACH is designed to demonstrate the potential of losmapimod to slow disease progression and address the debilitating effects of FSHD. We believe losmapimod could be the first approved treatment for this disease. With the clinical hold for pociredir lifted, we have been working diligently to resume enrollment in the Phase 1b trial for patients with SCD and look forward to building on the encouraging early clinical data observed to date. We remain very excited about pociredir’s potential to shift the current standard of care and importantly, offer a differentiated oral option.” Recent Business Highlights In September 2023, completed enrollment in REACH, a Phase 3 clinical trial evaluating losmapimod in patients with FSHD at sites in the United States, Canada, and Europe. The trial enrolled 260 patients. Fulcrum expects to report topline data in the fourth quarter of 2024. There are currently no approved treatments for FSHD.In August 2023, the FDA lifted the clinical hold on the Investigational New Drug...