Press release
Fulcrum Therapeutics Announces Recent Business Highlights and Financial Results for Second Quarter 2024
― On track to report topline data for Phase 3 REACH trial of losmapimod in facioscapulohumeral muscular dystrophy (FSHD) by the end of October 2024 ― ―
About this update from Fulcrum Therapeutics, Inc.
[{"type":"text","content":"― On track to report topline data for Phase 3 REACH trial of losmapimod in facioscapulohumeral muscular dystrophy (FSHD) by the end of October 2024 ― ― Entered into a collaboration and ex-U.S. license agreement with Sanofi for the development and commercialization of losmapimod ― ― Conference call and webcast scheduled for 8:00 a.m. ET today ― CAMBRIDGE, Mass., July 31, 2024 (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 second quarter of 2024 as well as a business update. “We are on track to report topline results for the Phase 3 REACH trial by the end of October 2024, and as we advance towards this important inflection point, we continue to prepare for the potential NDA filing and the U.S. launch of losmapimod. In parallel, we are working with Sanofi in preparation for regulatory filings and the launch of losmapimod outside of the U.S.,” said Alex C. Sapir, Fulcrum’s president and chief executive officer. “Our Phase 1b PIONEER trial of pociredir, currently in development as a highly differentiated oral treatment option for sickle cell disease, continues to make progress. Our excitement for this program is based on the initial data generated in the Phase 1b trial, which suggests that pociredir has potential to raise HbF to levels that could ameliorate symptoms of the disease.” Recent Business Highlights REACH, the Phase 3 clinical trial evaluating losmapimod in patients with FSHD, continues to progress, and Fulcrum expects to report topline data by the end of October 2024. The trial enrolled 260 patients across sites in the United States, Canada, and Europe. There are currently no approved treatments for FSHD. As of June 30, 2024, 234 patients had completed the Part A 48-week treatment phase of the clinical trial, of which 232 chose to enroll in the Part B Open Label Extension phase.Fulcrum is on track to complete the activities agreed-upon with the U.S. Food and Drug Administration (FDA) to define the clinical meaningfulness of RWS, the primary endpoint of the REACH trial, at the time of reporting topline data. Presented multiple abstracts at the 31st Annual FSHD Society International Research Congress held J...