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Fulcrum’s Losmapimod Improves Multiple Measures, But Not Primary Endpoint

Secondary Endpoints May Matter More In FSHD Study

 
• By Alaric DeArment

The ReDUX4 study missed its biomarker-driven primary endpoint, making it unclear if an additional trial will be needed for regulatory submission.

MUSCULAR DYSTROPHY words written on label tag with medicine,syringe,keyboard and stethoscope
Fulcrum presented data from the Phase IIb study of losmapimod in FSHD • Source: Shutterstock

Fulcrum Therapeutics Inc. is arguing that although losmapimod failed to meet the primary endpoint in the Phase IIb ReDUX4 study in facioscapulohumeral muscular dystrophy (FSHD), it met other endpoints measuring clinical benefit that are more important. Whether it can convince the US Food and Drug Administration or will need to conduct another trial could set an important standard for other companies with DUX4-targeting drugs for FSHD currently in preclinical development.

The ReDUX4 results were presented 24 June at the FSHD International Research Congress, showing what Cambridge, MA-based Fulcrum said were...

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