Edgewise Therapeutics has announced the start of enrollment of GRAND CANYON, the company’s global pivotal study of EDG-5506 in individuals with Becker. GRAND CANYON is an expansion of the CANYON study, which was over-enrolled. EDG-5506 is a small molecule, taken orally, that is intended to help protect muscle by reducing injury during contraction and relaxation of fast-twitch skeletal muscle.
GRAND CANYON is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of EDG-5506 in adults with Becker. The primary endpoint of GRAND CANYON is North Star Ambulatory Assessment (NSAA). In addition, other functional assessments, biomarkers of muscle damage and safety will be assessed.
GRAND CANYON is anticipated to recruit approximately 120 individuals with Becker, aged between 18 and 50 years old, at up to 50 sites in 10 countries. The treatment period for participants will be 18 months.
PPMD is pleased that this trial will offer individuals with Becker another option for participating in a pivotal trial focused solely on Becker. Edgewise joined PPMD for a community webinar on October 18 at 1 PM ET to share details about the trial and answer questions from the community. Watch the recording here.
Read Edgewise’s press release here.