Edgewise Therapeutics Posts Data From Early-Stage Muscle Wasting Disease Trial
- Edgewise Therapeutics Inc (NASDAQ: EWTX) has announced topline results from the MAD portion of Phase 1 trial of EDG-5506, designed to protect skeletal muscle fibers in Duchenne muscular dystrophy (DMD) and Becker Muscular Dystrophy (BMD).
- EDG-5506 was shown to be generally well-tolerated at all doses studied with no adverse events.
- The most common adverse events were dizziness and somnolence, which were mild, transient, and self-resolving.
- PK data demonstrated robust target engagement with high muscle exposures consistent with EDG-5506's expected high-affinity binding to myosin in fast skeletal muscle fibers.
- EDG-5506 inhibited involuntary twitch in healthy volunteers at muscle concentrations consistent with levels demonstrating efficacy in preclinical disease models.
- Also, dosing with EDG-5506 was not found to affect voluntary grip, shoulder, or hip strength, and no negative impact was observed on alternate forms of myosin elsewhere in the body.
- The Company plans to initiate Phase 2 trials in BMD in 1H of 2022 and DMD in 2H of 2022.
- Price Action: EWTX shares closed 2.53% lower at $16.20 on Wednesday.
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Posted-In: Briefs Duchenne Muscular Dystrophy Phase 1 TrialBiotech News Health Care Small Cap General
