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Fulcrum : Phase 2b Trial On Facioscapulohumeral Muscular Dystrophy Fails To Meet Main Goal

Fulcrum Therapeutics Inc. (FULC) said Thursday that its phase 2b trial for people with facioscapulohumeral muscular dystrophy or FSHD did not meet its primary endpoint.

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.

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.

The trial results with losmapimod 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.

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