On September 12th, 2024, Fulcrum announced that its Phase 3 REACH trial evaluating losmapimod in patients with FSHD, did not achieve its primary endpoint of change from baseline in RSA (measure of reachable workspace) with losmapimod compared to placebo. In addition, secondary endpoints did not achieve nominal statistical significance. The company decided to suspend its development of Losmapimod.
Although this news is disappointing, there will be important lessons to learn, and FSHD Europe thank Fulcrum for pioneering clinical trials for FSHD.
FSHD Europe would like to express our appreciation to all the patients who participated in the Fulcrum trials. To all patients and families, keep in mind there are many other therapies in developments (Drug Development Pipeline | FSHD Society). FSHD Europe is committed and dedicated to work towards our collective goal in finding a treatment for FSHD.