Fulcrum Therapeutics has announced successful completion of patient enrollment in REACH Phase 3 trial
RANDOLPH, Mass., Sept. 8, 2023 /PRNewswire-PRWeb/ -- The FSHD Society, a leading advocate and partner in the quest to find treatments for Facioscapulohumeral Muscular Dystrophy (FSHD), is thrilled to announce a significant milestone in the battle against this progressive muscle-wasting condition that affects approximately one million people globally. 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."
About the FSHD Society
The FSHD Society is the world's largest research-focused patient advocacy organization for facioscapulohumeral muscular dystrophy (FSHD), one of the most prevalent forms of MD. Over the past 32 years, the organization has catalyzed major advancements and worked to accelerate the development of treatments and a cure to end the pain, disability, and suffering endured by one million people worldwide who live with FSHD. The FSHD Society has transformed the landscape for FSHD research and is committed to making sure that no one faces this disease alone.
The Society offers a community of support, news, and information through its website at https://www.fshsociety.org.
About Fulcrum Therapeutics
Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum's two lead programs in clinical development are losmapimod, a small molecule for the treatment of facioscapulohumeral muscular dystrophy (FSHD), and pociredir, formerly FTX-6058, a small molecule designed to increase expression of fetal hemoglobin for the treatment of sickle cell disease (SCD) and other hemoglobinopathies. Fulcrum's proprietary product engine, FulcrumSeek™, identifies drug targets that can modulate gene expression to treat the known root cause of gene mis-expression. For more information, visit http://www.fulcrumtx.com.
About Project Mercury
Project Mercury is an open collaboration among stakeholders from across the globe coming together to overcome the challenges that could slow or prevent effective FSHD therapies from getting to patients everywhere. This collaboration takes place at the global level through a Global Task Force and at the local level, through Country Working Groups. The Task Force and the Working Groups are all led by patient advocacy organizations of the World FSHD Alliance. This global-local approach ensures customization of Project Mercury's work at the local level while sharing resources at the global level. More information about Project Mercury can be found at https://www.projectmercuryfshd.org.
Media Contact
June Kinoshita, FSHD Society, 781-301-6649, [email protected], https://www.fshdsociety.org
SOURCE FSHD Society
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