London: Fulcrum Therapeutics announced on Thursday that its investigational treatment for
a muscle disorder did not meet the primary objective in a pivotal late-stage trial, resulting in a
nearly 70% drop in the company’s stock before the market opened.
The pharmaceutical company was evaluating its drug, losmapimod, in a trial involving 260
participants with facioscapulohumeral muscular dystrophy (FSHD). The patients were either
given the drug or a placebo over a period of 48 weeks. By the end of the treatment phase,
those receiving losmapimod showed no improvement in shoulder and upper arm mobility, the
trial’s primary outcome measure.
Additionally, the study failed to reach statistical significance on any of its secondary
endpoints.
Following these results, the company has decided to halt further testing of losmapimod in
FSHD patients.
FSHD is a hereditary condition characterized by muscle weakness and atrophy, primarily
affecting the face, shoulders, and upper arms. According to the Muscular Dystrophy
Association, it affects around 4 out of every 100,000 people.
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