Benzinga | Jun 24, 2021 07:02AM EDT

Fulcrum Therapeutics Announces Results from ReDUX4 Trial with Losmapimod in Facioscapulohumeral Muscular Dystrophy Demonstrating Slowed Disease Progression and Improved Function Did Not Meet Primary Endpoint

* Primary endpoint, change in DUX4-driven gene expression which was included as an experimental biomarker, was not met

* Losmapimod showed statistically significant&#x2A; (p<0.05) and clinically relevant benefit across multiple structural, functional and patient reported endpoints Decreased Muscle Fat Infiltration Improved Reachable Workspace Improved Patient Global Impression of Change

* Losmapimod was well tolerated with no treatment related discontinuations or treatment related serious adverse events

* Positive benefit/risk supports losmapimod's potential to be a transformative therapy for the treatment of FSHD

* Fulcrum expects to engage with health authorities, including the FDA, in H2 2021 Fulcrum to host conference call today at 8:00am ET; Full data to be presented at FSHD International Research Congress today at 1:33pm ET