Fulcrum Therapeutics' Losmapimod Receives the US FDA's Fast Track Designation to Treat Facioscapulohumeral Muscular Dystrophy
Shots:
- The US FDA has granted FTD to losmapimod for the treatment of FSHD while the therapy has previously received ODD for FSHD
- The company will present full data from the P-IIb ReDUX4 trial assessing losmapimod vs PBO in patients with FSHD at FSHD on June 24-25- 2021 that include 1EP results i.e.- reduction from baseline of DUX4-driven gene expression and pre-specified sensitivity analysis assessing biopsies with the highest pre-treatment level of DUX4-driven gene expression
- The additional 2EPs results i.e.- disease progression via skeletal muscle MRI- exploratory EPs evaluate muscle function measures and patient-reported outcomes
Ref: Fulcrum Therapeutics | Image: Fulcrum Therapeutics
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