USFDAJul 28, 2026, 07:32 AM
Dyne Therapeutics Receives FDA IND Clearance for DYNE-302 in FSHD
AI Summary
Dyne Therapeutics announced it has received U.S. Food and Drug Administration (FDA) clearance for its Investigational New Drug (IND) application to initiate a Phase 1 clinical trial for DYNE-302 in facioscapulohumeral muscular dystrophy (FSHD). This marks the company's third program to enter clinical development, leveraging its proprietary FORCE platform. DYNE-302 aims to address the significant unmet medical needs of individuals living with FSHD, a rare, progressive, inherited muscle disease with no approved therapies.
Key Highlights
- Dyne Therapeutics received FDA IND clearance for DYNE-302 in FSHD.
- Company to initiate Phase 1 clinical trial for DYNE-302 in facioscapulohumeral muscular dystrophy (FSHD).
- DYNE-302 is the third program leveraging Dyne's FORCE platform to enter clinical development.
- FSHD is a rare, progressive, inherited muscle disease with no approved therapies.
- Phase 1 trial will be randomized, placebo-controlled, double-blind, multiple ascending dose (MAD).
- First cohort will involve 9 participants receiving 1.5 mg/kg DYNE-302 or placebo every four weeks.
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