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Fulcrum Therapeutics Announces Topline Results from Phase 3 REACH Clinical Trial of Losmapimod in Facioscapulohumeral Muscular Dystrophy (FSHD)
Fulcrum Therapeutics (NASDAQ: FULC) announced that its Phase 3 REACH trial for losmapimod in Facioscapulohumeral Muscular Dystrophy (FSHD) failed to meet its primary endpoint. The trial showed no significant improvement in relative surface area (RSA) compared to placebo at week 48. Secondary endpoints also failed to achieve statistical significance. As a result, Fulcrum plans to suspend the losmapimod program in FSHD.
Key results include:
Losmapimod group: 0.013 improvement in RSA
Placebo group: 0.010 improvement in RSA
No significant differences in muscle fat infiltration, shoulder abductor strength, or patient-reported outcomes
Despite this setback, Fulcrum remains financially stable with $273.8 million in cash and equivalents as of June 30, 2024. The company will redirect its resources to advance pociredir for sickle cell disease and other early-stage programs.
Fulcrum Therapeutics (NASDAQ: FULC) announced that its Phase 3 REACH trial for losmapimod in Facioscapulohumeral Muscular Dystrophy (FSHD) failed to meet its primary endpoint. The trial showed no significant improvement in relative surface area (RSA) compared to placebo at week 48. Secondary endpoints also failed to achieve statistical significance. As a result, Fulcrum plans to suspend the losmapimod program in FSHD.
Key results include:
Losmapimod group: 0.013 improvement in RSA
Placebo group: 0.010 improvement in RSA
No significant differences in muscle fat infiltration, shoulder abductor strength, or patient-reported outcomes
Despite this setback, Fulcrum remains financially stable with $273.8 million in cash and equivalents as of June 30, 2024. The company will redirect its resources to advance pociredir for sickle cell disease and other early-stage programs.
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