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Satellos Changes Primary Efficacy Endpoint in BASECAMP Phase 2 Pediatric Trial to MRI-Measured Fat Fraction Following FDA Feedback
GlobeNewswire Inc.·
Satellos Bioscience announced it has changed the primary efficacy endpoint in its BASECAMP Phase 2 clinical trial from dynamometry to MRI-measured fat fraction of the vastus lateralis, following FDA feedback. The change aims to support a potential accelerated approval pathway for forazapadin, its investigational treatment for Duchenne muscular dystrophy. Topline 12-week placebo-controlled data is expected in Q1 2027. Prior TRAILHEAD data in adults showed a 3.7 percentage-point reduction in muscle fat fraction, indicating improved muscle composition.
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