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A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of EDG-5506 on Safety, Biomarkers, Pharmacokinetics, and Functional Measures in Adults and Adolescents With Becker Muscular Dystrophy

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Trial Profile

A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of EDG-5506 on Safety, Biomarkers, Pharmacokinetics, and Functional Measures in Adults and Adolescents With Becker Muscular Dystrophy

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 16 May 2024

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At a glance

  • Drugs Sevasemten (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Adverse reactions; Biomarker; Registrational; Therapeutic Use
  • Acronyms CANYON; GRAND CANYON
  • Sponsors Edgewise Therapeutics
  • Most Recent Events

    • 22 Feb 2024 According to an Edgewise Therapeutics media release, company expects to report CANYON data in the fourth quarter of 2024. Data from GRAND CANYON, if positive, could support a marketing application.
    • 09 Jan 2024 According to an Edgewise Therapeutics media release, the company planned to announce 1-year data in the second half of 2024.
    • 09 Nov 2023 According to an Edgewise Therapeutics media release, CANYO is fully enrolled includes 40 adults and 29 adolescents and a treatment period of 12 months and now enrolling the global pivotal cohort, GRAND CANYON anticipated to recruit approximately 120 individuals with Becker, aged between 18 and 50 years old, at up to 50 sites in 10 countries.
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