Fulcrum Therapeutics Announces Initiation of ReDUX4, a Phase 2b Clinical Trial of Losmapimod for FSHD

August 19, 2019 at 7:00 AM EDT

CAMBRIDGE, Mass., Aug. 19, 2019 (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 it has initiated ReDUX4, a Phase 2b clinical trial of losmapimod in facioscapulohumeral muscular dystrophy (FSHD). The clinical trial is designed to evaluate the efficacy and safety of losmapimod, an investigational selective p38α/β MAPK inhibitor, in addressing the underlying cause of FSHD, a rare, progressive and disabling muscular dystrophy. 

“We are excited to evaluate losmapimod’s efficacy and safety in FSHD, a disease for which there are currently no approved treatments,” said Robert J. Gould, Ph.D., Fulcrum’s president and chief executive officer. “Initiating ReDUX4 is a significant milestone that brings us a step closer to our goal of improving the lives of patients and families who are impacted by FSHD. Losmapimod, a p38α/β mitogen activated protein kinase (MAPK) inhibitor identified through our proprietary product engine, reduced expression of the DUX4 gene in patient-derived muscle cells, which is the root cause of FSHD.”

The multicenter trial is a randomized, double-blind, placebo-controlled, 24-week study of losmapimod, and will enroll patients with genetically confirmed FSHD. The primary endpoint of the study is to evaluate the efficacy of losmapimod in inhibiting or reducing DUX4-driven gene expression. DUX4 expression will be measured by a subset of DUX4-regulated gene transcripts in skeletal muscle biopsies. Clinical data are expected in the third quarter of 2020. In parallel, Fulcrum will also initiate a 52-week open label study, which will include interim analyses.

Read full release here.

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3 responses to “Fulcrum Therapeutics Announces Initiation of ReDUX4, a Phase 2b Clinical Trial of Losmapimod for FSHD”

  1. That’s awesome… I hope it is a great success. I have FSHD since age 12 and now I am 59. I have so much trouble breathing I forget about the pain and trouble moving even though I exercise and eat healthy. I am sure everyone can relate. So I hope it’s a great success. I am very happy to hear about this study, every little bit helps to reach the cure. These days they cure AIDS and Cancer and Ebola. Why not FSHD too, it should be soon now hang in there baby! 🙂

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