Edgewise Therapeutics Announces Expansion of their EDG-5506 Clinical Program in Duchenne Muscular Dystrophy (Duchenne)

Edgewise Therapeutics Announces Expansion of their EDG-5506 Clinical Program in Duchenne Muscular Dystrophy (Duchenne)

(Please bear in mind that these trials are announced to be conducted in the USA)

BOULDER, Colo.–(BUSINESS WIRE)– Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, 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.

The expansion includes two key developments:

FOX Phase 2 Trial: Edgewise is initiating a new Phase 2 placebo-controlled FOX trial, designed to assess the impact of EDG-5506 in children and adolescent boys with Duchenne who have previously received gene therapy. The FOX trial, set to commence in early 2024, will span 12 weeks and evaluate safety, pharmacokinetics, and biomarkers of muscle damage.

LYNX Trial Expansion: The Phase 2 placebo-controlled LYNX trial is experiencing rapid enrollment at 14 sites across the United States, with the first three cohorts being over-enrolled. The LYNX trial aims to identify a dose of EDG-5506 that reduces biomarkers of muscle damage and has the potential to provide functional benefits, setting the stage for a Phase 3 trial.

Read the Press Release here

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