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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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Trial Profile

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: 18 May 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

  • 08 May 2025 According to a Wave Life Sciences media release, company plans to file a New Drug Application (NDA) in 2026 to support accelerated approval of WVE-N531 with monthly dosing and expects to submit clinical trial applications (CTAs) for additional exon skipping programs in 2026.
  • 08 May 2025 According to a Wave Life Sciences media release, in March 2025, company met with the U.S. Food and Drug Administration (FDA) on WVE-N531 to discuss its interim 24-week data and initial plans for the confirmatory trial, where the Agency confirmed that the accelerated approval pathway using dystrophin expression as a surrogate endpoint remains open.
  • 08 May 2025 According to a Wave Life Sciences media release, all participants in FORWARD-53 elected to advance to the extension portion of the clinical trial, which is currently ongoing with boys receiving monthly doses of WVE-N531. To ensure a monthly regimen at a potential launch, company is also expanding to include additional boys who will be dosed monthly.

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