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On Sunday, Dyne Therapeutics Said It Initiated Phase 3 HARMONIA Trial Of Zeleciment Basivarsen (Z-basivarsen, DYNE-101) For Myotonic Dystrophy Type 1

Benzinga·03/09/2026 09:14:02
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  • 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