Dyne: DYNE-101 achieves 27% splicing correction at 3 months; DYNE-251 shows 3.22% dystrophin expression in DMD

Dyne Therapeutics, Inc.

DYNE-101 5.4 mg/kg Q8W showed 27% mean splicing correction across 22-gene panel at 3 months, all participants responded.
DYNE-101 improved myotonia (vHOT) by 4.5 sec at 3 months (5.4 mg/kg) and 4.4 sec at 12 months (1.8 mg/kg Q4W).
DYNE-251 10 mg/kg monthly achieved mean unadjusted dystrophin 3.22% (7.64% muscle-adjusted) vs 0.30% for weekly eteplirsen.
DYNE-251 showed trends in functional endpoints: NSAA, SV95C, 10-Meter Walk/Run, and Time to Rise at 6 months.
Favorable safety for both; FDA accelerated approval pathways confirmed; registration pathway update expected by end of 2024.

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