Fulcrum Announces Initiation of ReDUX4, a Phase 2b Clinical Trial of Losmapimod for FSHD

CAMBRIDGE, Mass., Aug. 19, 2019 (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 it has initiated ReDUX4, a Phase 2b clinical trial of losmapimod in facioscapulohumeral muscular dystrophy (FSHD). The clinical trial is designed to evaluate the efficacy and safety of losmapimod, an investigational selective p38α/β MAPK inhibitor, in addressing the underlying cause of FSHD, a rare, progressive and disabling muscular dystrophy.

“We are excited to evaluate losmapimod’s efficacy and safety in FSHD, a disease for which there are currently no approved treatments,” said Robert J. Gould, Ph.D., Fulcrum’s president and chief executive officer. “Initiating ReDUX4 is a significant milestone that brings us a step closer to our goal of improving the lives of patients and families who are impacted by FSHD. Losmapimod, a p38α/β mitogen activated protein kinase (MAPK) inhibitor identified through our proprietary product engine, reduced expression of the DUX4 gene in patient-derived muscle cells, which is the root cause of FSHD.”

The multicenter trial is a randomized, double-blind, placebo-controlled, 24-week study of losmapimod, and will enroll patients with genetically confirmed FSHD. The primary endpoint of the study is to evaluate the efficacy of losmapimod in inhibiting or reducing DUX4-driven gene expression. DUX4 expression will be measured by a subset of DUX4-regulated gene transcripts in skeletal muscle biopsies. Clinical data are expected in the third quarter of 2020. In parallel, Fulcrum will also initiate a 52-week open label study, which will include interim analyses.

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