Satellos swaps primary endpoint in pediatric DMD trial after FDA feedback

Satellos Bioscience Inc. announced on November 6, 2026 that, after feedback from the FDA, it has selected change in vastus lateralis fat fraction measured by MRI as the primary efficacy endpoint in the BASECAMP Phase 2 study in boys ages 7, 8 or 9 with Duchenne muscular dystrophy¹. The new MRI-based measure takes the place of dynamometry as the trial's primary endpoint¹. The company has submitted a protocol amendment to put the new endpoint in place, and said fat fraction, together with clinical endpoints, may support a potential accelerated approval pathway for its drug candidate forazapadin, an oral small molecule.¹

Fat fraction is described as an objective MRI measure of muscle composition that quantifies the proportion of fat within muscle tissue, and because fat progressively replaces healthy muscle in DMD, a rising fat fraction is linked to disease progression while a decline may reflect muscle regeneration¹. Satellos cited encouraging data from its adult study, TRAILHEAD, where the company said in its "TRAILHEAD, adults treated with forazapadin demonstrated an improvement in muscle fat fraction of the biceps brachii over five months," according to Chief Medical Officer Wildon Farwell.

Specifically, TRAILHEAD data showed a mean 3.7 percentage-point reduction in MRI-measured muscle fat fraction of the biceps brachii, from 49.7% at baseline to 46.0% at Day 140, which the company said indicated improved muscle composition¹.

BASECAMP is a global, Phase 2, randomized, double-blind, placebo-controlled study enrolling 53 ambulatory boys with DMD ages 7, 8 or 9, with a 12-week placebo-controlled period followed by a 36-week period in which all participants receive forazapadin¹. Satellos said topline 12-week placebo-controlled BASECAMP data are expected in the first quarter of 2027¹.