- HARMONIA trial will assess multi-system efficacy, safety and tolerability of z-basivarsen in DM1 - - 48-week trial will enroll approximately 150 individuals, and first sites are now open for enrollment - - Primary endpoint is the five times sit to stand (5xSTS) test; secondary and exploratory endpoints will assess muscle function, CNS manifestations, and patient- and clinician-reported outcomes - - HARMONIA trial design and protocol aligned with FDA; trial intended to serve as confirmatory trial for traditional approval in the U.S. and support ex-U.S. marketing applications - WALTHAM, Mass., March 08, 2026 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular diseases, today announced the initiation of the Phase 3 HARMONIA trial of zeleciment basivarsen (z-basivarsen, also known as DYNE-101), in individuals with myotonic dystrophy type 1 (DM1).
