Fulcrum Therapeutics intitiates Phase 2b clinical trial of losmapimod for FSHD
Fulcrum Therapeutics announced it has initiated ReDUX4, a Phase 2b clinical trial of losmapimod in facioscapulohumeral muscular dystrophy. The clinical trial is designed to evaluate the efficacy and safety of losmapimod, an investigational selective p38alpha/beta MAPK inhibitor, in addressing the underlying cause of FSHD, a rare, progressive and disabling muscular dystrophy. 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.