The FSHD Society Celebrates Fulcrum’s Milestone in the Fight Against FSHD

Fulcrum Therapeutics has announced successful completion of patient enrollment in REACH Phase 3 trial

The FSHD Society is thrilled to announce a significant milestone in the battle against FSHD. Fulcrum Therapeutics, Inc. (Nasdaq: FULC), a pioneering biopharmaceutical company focused on rare diseases, confirmed the completion of patient enrollment in the Phase 3 REACH clinical trial for losmapimod, a potential groundbreaking therapy for FSHD.

The FSHD Society has played an instrumental role in advancing the progress of the REACH Phase 3 trial. The Society has collaborated closely with Fulcrum’s team to facilitate vital groundwork for this achievement. Over recent years, the FSHD Society has organized patient focus groups, sought insights from key opinion leaders, and contributed to the accumulation of valuable data from earlier studies conducted at Clinical Trial Research Network (CTRN) sites. Collective effort has led to the advancement of the REACH trial, offering hope to the entire FSHD community.

In addition, the Society, along with other patient advocacy groups, helped found and launch Project Mercury, a global collaboration platform to address clinical trial readiness and patient access around the world. Fulcrum is a sustaining industry member of Project Mercury. Project Mercury is key to both the Society and Fulcrum’s ongoing work together. Mel Hayes, Chief Operations Officer of Fulcrum, commented on the FSHD Society’s contribution to the REACH trial: “As the global sustaining member of Project Mercury and a longtime collaborator with the FSHD Society, Fulcrum is excited to announce that we have reached a major milestone with completion of enrollment in the REACH Phase III clinical trial. This REACH milestone, coupled with Project Mercury’s global task force ambitions and the Society’s work to prepare the FSHD community for its potential first therapy for FSHD serves as an inflection point for the FSHD community.”

Fulcrum Therapeutics has successfully enrolled 260 patients in the REACH Phase 3 trial across nine countries in the United States, Canada, and Europe. The trial employs a rigorous, double-blind, placebo-controlled design to evaluate the efficacy and safety of losmapimod for FSHD treatment. Patients were randomized 1:1 to receive either losmapimod, administered orally as a 15 mg tablet twice a day, or a placebo. Over a 48-week treatment period, various endpoints, including Reachable Workspace (RWS), muscle fat infiltration (MFI), Patient Global Impression of Change (PGIC), and Quality of Life in Neurological Disorders of the Upper Extremity (Neuro QoL UE), will be assessed. Moreover, REACH encompasses patient-centered evaluations of healthcare utilization.

Topline data from the Phase 3 REACH trial is anticipated to be reported in Q4 of 2024, bringing the FSHD community one step closer to the potential approval of the first-ever therapy for this challenging condition. Read the full press release from Fulcrum Therapeutics here.

Mark Stone, CEO of the FSHD Society, conveyed his excitement about the importance of this news for the FSHD community by stating, “This represents reaching a significant milestone and is a major step forward to providing safe and effective treatments for everyone living with FSHD! We are proud of our partnership with Fulcrum and the impact they are having on drug development in FSHD.”