Other Events ·
Satellos changes BASECAMP Phase 2 primary endpoint to MRI-measured fat fraction following FDA feedback
MSCLDSatellos Bioscience Inc.
Following feedback from the U.S. Food and Drug Administration (FDA), Satellos Bioscience has amended its protocol for the BASECAMP Phase 2 clinical study in boys with Duchenne muscular dystrophy (DMD). The company selected change in vastus lateralis fat fraction measured by magnetic resonance imaging (MRI) as the new primary efficacy endpoint, replacing dynamometry. This objective measure of muscle composition is intended to serve as a surrogate endpoint reasonably likely to predict clinical benefit and support a potential accelerated approval pathway for forazapadin. Topline 12-week placebo-controlled data from the trial are expected in Q1 2027. Satellos Bioscience Inc. is a clinical-stage biotechnology company developing potentially life-improving medicines to treat degenerative muscle disorders.