BridgeBio completes enrollment of FORTIFY Phase 3 study of BBP-418

BridgeBio Pharma announced, on LGMD Awareness Day, the completion of enrollment of FORTIFY, the Company’s Phase 3 registrational study of BBP-418 in individuals with LGMD2I/R9. FORTIFY is a randomized, double-blind, placebo-controlled Phase 3 study evaluating the safety and efficacy of BBP-418, an investigational oral therapy in development for the treatment of individuals living with LGMD2I/R9. The study includes a planned interim analysis at 12 months focused on assessing glycosylated alphaDG as a surrogate endpoint to potentially support Accelerated Approval. The primary endpoint, to be evaluated at 36 months, is the North Star Assessment for limb-girdle type muscular dystrophies and is designed to provide confirmatory clinical data supporting the efficacy of BBP-418. A topline data readout from the interim analysis is expected in 2025.