Dyne Therapeutics Announces U.S. FDA Clearance of Investigational New Drug (IND) Application for DYNE-302 in Facioscapulohumeral Muscular Dystrophy (FSHD)
Dyne Therapeutics received FDA clearance for its IND application to initiate a Phase 1 clinical trial of DYNE-302 for the treatment of facioscapulohumeral muscular dystrophy (FSHD). The randomized, placebo-controlled trial will first evaluate safety and tolerability with a 1.5 mg/kg dose administered every four weeks in nine participants.
Key figures
- Drug Name
- DYNE-302
- Phase Of Trial
- Phase 1
- Cohort 1 dose
- 1.5 mg/kg
- Dosing frequency
- Q4W
- Randomization ratio
- 2:1
- Cohort 1 participants
- 9
- Eu patient population
- 20,000 to 50,000
- Us patient population
- 15,000 to 40,000
- Long term extension weeks
- 96
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