Satellos Bioscience Alters Primary Endpoint in BASECAMP Duchenne Trial Following FDA Feedback
Satellos Bioscience has announced a significant change to the primary endpoint in its Phase 2 BASECAMP clinical trial. This trial is evaluating forazapadin, an investigational oral, small molecule designed to enhance skeletal muscle repair and regeneration in individuals with Duchenne muscular dystrophy. Following feedback from the U.S. Food and Drug Administration (FDA), the company will replace dynamometry, which measures muscle strength, with MRI-measured muscle fat fraction as the study's primary efficacy endpoint. The BASECAMP trial involves 53 ambulatory boys aged 7–9 living with Duchenne. The study's initial 12-week period compares forazapadin with a placebo, followed by 36 weeks where all participants receive the investigational therapy. Satellos anticipates reporting topline results from the 12-week placebo-controlled period in the first quarter of 2027.
