Press release
Fulcrum Therapeutics Reports Recent Business Highlights and First Quarter 2020 Financial Results
Conference call scheduled for 8:00 a.m. ET today CAMBRIDGE, Mass., May 13, 2020 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (Nasdaq: FULC), a
About this update from Fulcrum Therapeutics, Inc.
[{"type":"text","content":"Conference call scheduled for 8:00 a.m. ET today\nCAMBRIDGE, Mass., May 13, 2020 (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 provided a business update and reported financial results for the first quarter of 2020.\n “Despite these unprecedented times, the first quarter was a period of important progress for Fulcrum and the fundamentals of our business remain strong,” said Robert J. Gould, Ph.D., president and chief executive officer. “I am proud of our continued commitment to patients and the dedication demonstrated by our employees in these challenging times. In the wake of COVID-19, a number of our clinical trial sites postponed their activities. Our team acted swiftly to minimize the health risks to patients, families and healthcare professionals involved in our studies of losmapimod in the treatment of facioscapulohumeral dystrophy (FSHD). We amended our Phase 2b trial, ReDUX4, to extend the trial from 24 to 48 weeks, added an interim analysis for subjects who underwent their 16-week biopsy as originally planned, and added a 36-week biopsy for patients who cannot undergo their 16-week biopsy. We believe these changes will enable patients and investigators to continue participation in the trial and will allow us to collect the essential data needed to evaluate the potential efficacy and safety of losmapimod for the treatment of FSHD.” Recent Business Highlights Amended ReDUX4, a Phase 2b trial of losmapimod, a selective p38α/β mitogen activated protein kinase (MAPK) inhibitor, to accommodate COVID-19 impact; extended the trial from 24 to 48 weeks, adding a 36-week biopsy for those subjects unable to undergo their 16-week biopsy, and included an interim analysis on patients who completed their 16-week biopsy as planned in the original protocol. ReDUX4 enrollment completed.ReDUX4 open label extension initiated.Data from interim analysis expected in the third quarter of 2020. Received U.S. and European Orphan Designation for losmapimod in FSHD.Completed investigational new drug application (IND)-enabling studies, including toxicology work with FTX-6058. Remain on track to initiate Phase 1 trial in the second half of 2020.FTX-6058 is an oral small molecule therapeutic discovered by...