Press release
Fulcrum Therapeutics to Evaluate Losmapimod as Potential Treatment for COVID-19
Investigational New Drug (IND) application submitted; Company preparing to initiate Phase 3 trial ReDUX4 interim analysis in facioscapulohumeral dystrophy
About this update from Fulcrum Therapeutics, Inc.
[{"type":"text","content":"Investigational New Drug (IND) application submitted; Company preparing to initiate Phase 3 trial\n ReDUX4 interim analysis in facioscapulohumeral dystrophy (FSHD) on track for Q3 2020 readout; FTX-6058 Phase 1 trial on track for Q4 2020 initiation Conference call scheduled for 8:30 a.m. ET today CAMBRIDGE, Mass., June 10, 2020 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced plans to evaluate losmapimod as a potential treatment for patients with COVID-19. Fulcrum has submitted an investigational new drug (IND) application to support initiation of a randomized, placebo-controlled, Phase 3 clinical trial in hospitalized patients in the United States following Pre-IND consultation via the Coronavirus Treatment Acceleration Program (CTAP). “The decision to advance this development program is a reflection of the compelling science that supports losmapimod’s potential in COVID-19,” said Robert J. Gould, Ph.D., Fulcrum’s president and chief executive officer. “Prior clinical trials have shown its ability in other disease states to reduce acutely the inflammatory cytokines, such as C-reactive protein and IL-6, that are associated with poor prognosis. This new planned Phase 3 program adds to our robust development portfolio including potential treatments for facioscapulohumeral dystrophy (FSHD) and sickle cell disease. We are excited to apply our insights and understanding of losmapimod in COVID-19 as a potential differentiated treatment option in the global fight against this virus. I am proud of the work by our team and collaborators to rapidly advance this planned clinical program and look forward to collaborating with regulators and our outstanding team of clinical investigators to move this important effort forward as quickly as possible.” “An extensive body of data in the literature suggests that inhibiting p38 MAP kinase may be beneficial for patients with COVID-19,” said Owen B. Wallace, Ph.D., Fulcrum’s chief scientific officer. “Poor prognosis for COVID-19 patients has been attributed to an exaggerated inflammatory response following SARS-CoV-2 infection. Losmapimod has been shown in preclinical and clinical studies to reduce proteins associated with acute inflammatory stre...