Clinical TrialNov 6, 2026, 07:01 AM
Satellos Changes DMD Trial Endpoint to MRI Fat Fraction After FDA Feedback
AI Summary
Satellos Bioscience Inc. announced a significant change to its BASECAMP Phase 2 clinical trial for forazapadin, a drug candidate for Duchenne muscular dystrophy (DMD). Following FDA feedback, the company has selected MRI-measured fat fraction as the primary efficacy endpoint, replacing dynamometry. This change is intended to support a potential accelerated approval pathway. Topline data from the 12-week study are anticipated in Q1 2027. Previous data from the TRAILHEAD study in adults showed promising results with forazapadin.
Key Highlights
- Satellos changes primary efficacy endpoint in BASECAMP Phase 2 pediatric trial to MRI-measured fat fraction.
- Change in MRI-measured fat fraction will replace dynamometry as the study’s primary efficacy endpoint.
- Topline 12-week placebo-controlled BASECAMP data expected in Q1 2027.
- Forazapadin is an investigational oral, small molecule designed to enhance muscle repair and regeneration.
- BASECAMP is a Phase 2 study evaluating forazapadin in ambulatory boys with Duchenne muscular dystrophy (DMD).
- TRAILHEAD study in adults with DMD demonstrated a mean 3.7 percentage-point reduction in MRI-measured muscle fat fraction.
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