Press release
Fulcrum Therapeutics Announces Recent Business Highlights and Financial Results for the First Quarter 2023
― Appointed Alex C. Sapir CEO & President, effective July 1st, 2023 ― ― On track to complete enrollment in Phase 3 REACH trial of losmapimod in
About this update from Fulcrum Therapeutics, Inc.
[{"type":"text","content":"― Appointed Alex C. Sapir CEO & President, effective July 1st, 2023 ― ― On track to complete enrollment in Phase 3 REACH trial of losmapimod in facioscapulohumeral muscular dystrophy (FSHD) during 2H’23 ― ― Active discussions continue with the U.S. Food and Drug Administration (FDA) to resolve clinical hold for FTX-6058 in sickle cell disease (SCD) ― ― Conference call and webcast scheduled for 8:00 a.m. ET today ― CAMBRIDGE, Mass., May 15, 2023 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (the “Company”) (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today reported financial results for the first quarter 2023 and provided a business update. “With today’s announcement of Alex as our next CEO and President, Fulcrum has ended the first quarter of 2023 in a position of strength and with great promise for the future,” said Robert J. Gould, Ph.D., Fulcrum’s interim president and chief executive officer. “We continue to engage in productive dialogue with the FDA, as we work diligently to address the clinical hold for FTX-6058. Additionally, we remain on track to complete enrollment in the Phase 3 REACH trial in the second half of 2023, which will bring us one step closer to potentially delivering the first FDA-approved therapy for FSHD patients.” Key Business Updates FTX-6058 On February 23, 2023, the FDA placed the investigational new drug (IND) application for FTX-6058 for the potential treatment of SCD on full clinical hold. In its communication, the Agency noted preclinical data previously submitted in April, October and December 2022, a response to an early February 2023 information request from the FDA about data that we submitted in mid-February 2023, and non-clinical and clinical evidence of hematological malignancies observed with other inhibitors of polycomb repressive complex 2 (PRC2).Active discussions with the Agency regarding the clinical hold of FTX-6058 are ongoing. Initial data reported in March 2023 but obtained prior to the clinical hold showed a 10.0% absolute fetal hemoglobin (HbF) increase from baseline in one subject in the 12 mg dose cohort of the Phase 1b clinical trial in SCD, resulting in a total HbF level of 24.9% after 42 days of treatment.FTX-6058 was generally well-tolerated, as of the March 2023 data cutoff ...