 CAMBRIDGE, Mass., June 24, 2021 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 announced results from the companys Phase 2b trial, ReDUX4, in people with facioscapulohumeral muscular dystrophy FSHD. Results being presented with losmapimod at the FSHD International Research Congress today showed clinically relevant and statistically significant benefits versus placebo on multiple measures of structural and functional FSHD disease progression and patient reported outcomes at 48 weeks. Losmapimod was generally well-tolerated, with no drug-related serious adverse events reported. Consistent with the previously reported interim analyses the primary endpoint was not met. Changes in DUX4-driven gene expression, which were included in the trial as an experimental biomarker endpoint, could not be demonstrated, the Company believes due to several technical and biologic variables with the endpoint. Based on todays results, the Company plans to meet with health authorities, including the U.S. Food and Drug Administration FDA, in the second half of 2021 to determine the regulatory path for losmapimod in FSHD. 