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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Global Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Intravenous AOC 1044 (Delpacibart Zotadirsen) for the Treatment of DMD With Gene Mutations Amenable to Exon 44 Skipping

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Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Global Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Intravenous AOC 1044 (Delpacibart Zotadirsen) for the Treatment of DMD With Gene Mutations Amenable to Exon 44 Skipping

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 20 May 2026

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At a glance

  • Drugs Delpacibart zotadirsenor (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Registrational; Therapeutic Use
  • Acronyms SAFARI44
  • Sponsors Avidity Biosciences

Most Recent Events

  • 14 May 2026 Status changed from planning to not yet recruiting.
  • 21 Mar 2026 New trial record
  • 26 Feb 2026 According to an Avidity Biosciences media release, the company will present trial design for this study in a poster presentation on 9 Mar 2026 at the 2026 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference, being held March 8-11, 2026, in Orlando, Florida..

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