Edgewise Therapeutics announces expansion of EDG-5506 program in Duchenne

Edgewise Therapeutics announced an expansion of their clinical development program of EDG-5506, an investigational orally administered small molecule designed to prevent contraction-induced muscle damage in dystrophinopathies, including Duchenne. The Company is initiating FOX, a new Phase 2 placebo-controlled trial in children and adolescent boys with Duchenne who have been previously treated with gene therapy. Further, the Company is continuing dose escalation and expanding enrollment in their Phase 2 placebo-controlled LYNX trial; one of the new LYNX cohorts will study EDG-5506 in boys with Duchenne not currently treated with corticosteroids…”We have listened to the Duchenne community and thoughtfully initiated FOX and expanded LYNX, both important advances in our EDG-5506 clinical development program. We anticipate moving towards a Phase 3 trial start in Duchenne in the second half of 2024,” said Joanne Donovan, M.D., Ph.D., Chief Medical Officer of Edgewise. “We are thrilled to open our studies of EDG-5506 to broader groups of individuals with Duchenne exploring the potential of a muscle-targeted therapeutic against the evolving treatment landscape.”