Satellos clears FDA hurdle for a new muscular-dystrophy trial

Satellos Bioscience ($MSLE) received FDA clearance for its investigational application to study forazapadin in facioscapulohumeral muscular dystrophy. The company plans to start a randomized, placebo-controlled Phase 2 study in the fourth quarter, extending development into an additional muscle disease. The trial will assess the experimental treatment rather than provide commercial access to an approved medicine.

The program is supported by an agreement for up to $5 million in non-dilutive funding from the FSHD Canada Foundation. Payments depend on milestones over five quarters, and the arrangement includes a capped share of potential future FSHD-related revenue. It should not be described as an unconditional grant. Trial clearance permits the research to proceed but does not establish clinical efficacy or predict a future approval.

Sources:

• Satellos — IND clearance and funding terms