Benzinga | Oct 28, 2021 07:29AM EDT

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.