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A potentially registrational Phase 2 trial of WVE-N531 to evaluate functional dystrophin expression following 24 and 48 weeks of biweekly dosing of WVE-N531

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A potentially registrational Phase 2 trial of WVE-N531 to evaluate functional dystrophin expression following 24 and 48 weeks of biweekly dosing of WVE-N531

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 07 Feb 2025

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At a glance

  • Drugs WVE-N531 (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Registrational; Therapeutic Use
  • Acronyms FORWARD-53
  • Sponsors WaVe life Sciences

    • Most Recent Events

    • 13 Jan 2025 According to a Wave Life Sciences media release, study is ongoing with all patients have elected to continue treatment in the planned extension portion of the study with monthly doses of WVE-N531.
    • 12 Nov 2024 According to a Wave Life Sciences media release, company expect feedback on a pathway to accelerated approval from regulators, as well as the complete 48-week FORWARD-53 data, in 1Q 2025
    • 01 Oct 2024 According to a Wave Life Sciences media release, company expects data from the complete FORWARD-53 study in the first quarter of 2025 and to receive feedback from regulators on a pathway to accelerated approval.

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