Press release
Fulcrum Therapeutics Announces Recent Business Highlights and Financial Results for the Fourth Quarter and Full Year 2022
― Company is working to address clinical hold on the Investigational New Drug application for FTX-6058 for the potential treatment of sickle cell disease ― ―
About this update from Fulcrum Therapeutics, Inc.
[{"type":"text","content":"― Company is working to address clinical hold on the Investigational New Drug application for FTX-6058 for the potential treatment of sickle cell disease ― ― FTX-6058 data from 12 mg cohort of Phase 1b trial show clinically relevant fetal hemoglobin increases of up to 10.0% ― ― On track to complete enrollment in Phase 3 REACH trial of losmapimod in facioscapulohumeral muscular dystrophy during 2H’23 ― ― In 1Q’23 completed public offering, generating approximately $117.3 million in net proceeds; Cash runway guidance into mid-2025 ― ― Company announces departure of Chief Medical Officer Santiago Arroyo, MD, Ph.D.; Appoints Iain Fraser, MBChB, D.Phil, as Interim Chief Medical Officer ― ― Conference call and webcast scheduled for 8:00 a.m. ET today ― CAMBRIDGE, Mass., March 09, 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 fourth quarter and full year 2022 and provided a business update, including on FTX-6058. “We are confident that FTX-6058 has the potential to provide a differentiated therapeutic option for people living with sickle cell disease and that the clinical and preclinical data generated to date demonstrate a favorable benefit-risk profile. We are working diligently to address the clinical hold,” said Robert J. Gould, Ph.D., Fulcrum’s interim president and chief executive officer. “Additionally, we remain on track to complete enrollment in the losmapimod Phase 3 REACH trial in the second half of 2023, and are excited about potentially being first to market with a treatment for FSHD patients who have no approved therapies.” 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 sickle cell disease (SCD) on full clinical hold. In its communication, the Agency noted preclinical data previously submitted in April, October and December 2022, and non-clinical and clinical evidence of hematological malignancies observed with other inhibitors of polycomb repressive complex 2 (PRC2).The Company received a formal Clinical Hold Letter from the Agency on February 24, 2023. Enrollment has been paused and dosing suspended in the Ph...