forazapadin (SAT-3247)

Sept. 24, 2026: Satellos Bioscience (NASDAQ: MSLE, TSX: MSCL) said the FDA cleared its IND for forazapadin in facioscapulohumeral muscular dystrophy (FSHD), expanding the program into a second clinical indication. The company expects to start a Phase 2 randomized, double-blind, placebo-controlled proof-of-concept study in Q4 2026 in adults with FSHD, evaluating oral 60 mg and 120 mg doses for safety, tolerability, pharmacokinetics, and potential efficacy.

Satellos also announced that the FSHD Canada Foundation will provide up to US$5 million in non-dilutive financing through milestone payments over the next five quarters, in exchange for a capped revenue-sharing interest in future FSHD-related proceeds.

Forazapadin is an oral small-molecule AAK1 inhibitor previously referred to as SAT-3247. In Duchenne muscular dystrophy (DMD), the company said ongoing Phase 2 development includes BASECAMP in pediatric participants and TRAILHEAD in adults. Preliminary data from the adult DMD Phase 2 trial showed a favorable safety profile, reduced muscle fat fraction by MRI, and increased total effort after six months of treatment at 60 mg.