Edgewise announces FDA authorization for Phase 2 DMD trial; positive ARCH interim data in BMD

Edgewise Therapeutics, Inc.

FDA authorized Phase 2 LYNX trial of EDG-5506 in children with DMD; dosing expected Q4 2022.
ARCH interim data: NSAA improved 1.17 points vs natural history decline of 1.22/year.
CK reduced 29% and fast skeletal muscle troponin I reduced 74% after 4 months.
9 of 12 BMD participants showed improvement or no decline on NSAA; no serious AEs observed.
EDG-5506 well-tolerated with no discontinuations; all patients dose escalated to 20 mg daily.

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