Press release
Fulcrum Therapeutics Announces Completion of Enrollment in Phase 2b Trial of Losmapimod for the Treatment of Facioscapulohumeral Muscular Dystrophy (FSHD)
Topline data on track for 3Q 2020 Dosing Initiated in ReDUX4 Open Label Extension CAMBRIDGE, Mass., Feb. 26, 2020 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics,
About this update from Fulcrum Therapeutics, Inc.
[{"type":"text","content":"Topline data on track for 3Q 2020 Dosing Initiated in ReDUX4 Open Label Extension CAMBRIDGE, Mass., Feb. 26, 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 that it has completed patient enrollment in ReDUX4, its double blind, placebo-controlled, international Phase 2b trial evaluating the efficacy and safety of losmapimod in patients with facioscapulohumeral muscular dystrophy (FSHD). An open label extension for participants in ReDUX4 who have completed 24 weeks of dosing has also initiated, providing the opportunity for patients randomized to losmapimod to continue treatment and for patients randomized to placebo to initiate treatment with losmapimod.\n “We want to express our gratitude to all the patients, investigators and caregivers participating in this global trial,” said Robert J. Gould, Ph.D., Fulcrum’s president and chief executive officer. “Completing patient recruitment for ReDUX4 is a testament to the commitment of the patient community, clinical investigators, our partners, and our Fulcrum team to address the critical needs of patients with FSHD and is a significant milestone. The root cause of FSHD is the aberrant activity of the DUX4 transcriptional program and we believe, as independent research indicates, that any reduction may be beneficial for patients. We remain on track to report topline data on the primary endpoint in the third quarter of this year.” About ReDUX4ReDUX4 is an international, multicenter, randomized, Phase 2b double-blind, placebo-controlled, 24-week trial of losmapimod in approximately 80 patients with genetically confirmed FSHD. The primary endpoint is the change from baseline on DUX4 activity in affected skeletal muscle. The open label extension allows patients randomized to losmapimod to continue treatment and for patients randomized to placebo to initiate treatment with losmapimod. In addition, Fulcrum finished enrollment in the Phase 2, 52-week open label study. About FSHDFSHD is characterized by progressive skeletal muscle loss that initially causes weakness in muscles in the face, shoulders, arms and trunk, and progresses to weakness throughout the lower body. Skeletal muscle weakness results in significant physical limitatio...