Shots:
- The US FDA has granted IND clearance to initiate a P-I multiple ascending dose trial assessing DYNE-302 against PBO in ambulatory adults with facioscapulohumeral muscular dystrophy (FSHD)
- In the first cohort, 9 pts will receive DYNE-302 (1.5 mg/kg, Q4W) or PBO, with higher doses & less frequent dosing planned. Pts completing the PBO-controlled phase may enter a 96wk. OLE study
- In preclinical FSHD models, DYNE-302 achieved robust DUX4 transcriptome knockdown in skeletal muscle, significantly reversed muscle fibre damage, & improved muscle function
Ref: Globenewswire | Image: Dyne Therapeutics | Press Release
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