Following the success of phase Ia and Ib, Edgewise Therapeutics announced in a July 2022 press release the launch of phase II to evaluate EDG-5506, an orally administered small molecule known to inhibit ATPase, which acts on fast fiber myosins, particularly affected in dystrophies. This evaluation will focus on safety, pharmacokinetics and effects on biomarkers and functional measures in Becker muscular dystrophy (BMD):
- this is a randomized, double-blind, placebo-controlled trial.
- 48 adults and 18 adolescents aged 12 years or older with BMD are expected to be enrolled at 14 sites in the U.S., U.K. and the Netherlands.
- the trial will be conducted over a 12-month treatment period, preceded by a four-week screening period and followed by a four-week follow-up period.
The company also announced the start of a phase II clinical trial to evaluate the efficacy of EDG-5506 in people with Duchenne muscular dystrophy.
Edgewise Therapeutics Now Enrolling CANYON Phase 2 Clinical Trial Of EDG-5506 In Individuals with Becker Muscular Dystrophy (BMD). Edgewise Therapeutics, July 12th, 2022 press release.
