Edgewise Therapeutics Posts Data From Early-Stage Muscle Wasting Disease Trial

Edgewise Therapeutics Inc 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.