Fulcrum announces Phase 3 trial of losmapimod

[Administrator]

March 03, 2022 — Fulcrum Therapeutics, Inc., a clinical-stage biopharmaceutical company, today announced its plans to initiate a Phase 3 clinical trial of losmapimod in people with facioscapulohumeral muscular dystrophy (FSHD), in the second quarter of 2022. FSHD is a serious, rare, progressive disease for which there are no approved treatments. It is characterized by fat infiltration of skeletal muscle leading to muscular atrophy involving the face, scapula and shoulders, upper arms, and abdomen.

“We are excited to advance losmapimod into the REACH Phase 3 trial for FSHD,” said Bryan Stuart, Fulcrum’s president and chief executive officer. “Results from the Phase 2b clinical trial demonstrated that losmapimod slowed disease progression and improved function in people with FSHD. Based on these data as well as insights gained from the trial on optimal measures of disease progression, we aligned with regulators, including the FDA, on key aspects of the design of the REACH trial. With positive data, we expect REACH to be the basis for approval. This marks a significant milestone for FSHD patients and caregivers, and Fulcrum remains committed to serving the FSHD community.”

Judith A. Dunn, Ph.D., Fulcrum’s president of research and development, said, “We learned from our Phase 2b trial that RWS, MFI and patient-reported outcomes are reliable measures of disease progression and that we can observe meaningful differences in these endpoints compared to placebo after just 48 weeks of treatment with losmapimod. REACH is optimized to demonstrate similar statistically and clinically significant benefits and represents an important step in delivering a life-changing therapy to people with FSHD.”

Results from ReDUX4, a randomized, double-blind, placebo-controlled Phase 2b trial, which enrolled approximately 80 patients treated for 48 weeks, demonstrated clinically relevant benefits on multiple measures of muscle health and function as well as patient-reported outcomes. Notably, losmapimod improved accessible surface area in RWS, a quantitative measure of upper extremity range of motion and function that has shown to correlate with the ability to independently perform activities of daily living. Losmapimod also decreased progression of fat infiltration in muscles already affected by disease and preserved the health of normal-appearing muscles. Additionally, losmapimod-treated patients reported feeling better compared to those on placebo using the assessment. Consistent with losmapimod’s extensive safety and tolerability profile from clinical trials outside of FSHD, there were no serious treatment-related adverse events observed in the Phase 2b trial.

https://www.fshdsociety.org/2022/03/03/ ... osmapimod/