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A Phase 2 Open-label Study to Evaluate the Pharmacodynamics and Long-Term Safety and Tolerability of AOC 1044 Administered Intravenously to DMD Participants With Mutations Amenable to Exon 44 Skipping

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Trial Profile

A Phase 2 Open-label Study to Evaluate the Pharmacodynamics and Long-Term Safety and Tolerability of AOC 1044 Administered Intravenously to DMD Participants With Mutations Amenable to Exon 44 Skipping

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

Latest Information Update: 17 Dec 2025

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At a glance

  • Drugs Delpacibart zotadirsenor (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Therapeutic Use
  • Acronyms EXPLORE44OLE
  • Sponsors Avidity Biosciences

Most Recent Events

  • 19 Nov 2025 According to an Avidity Biosciences media release, company aligned with FDA on a path forward for a BLA submission for del-zota following an October 2025 pre-BLA meeting, with the submission planned for 2026 for accelerated approval.
  • 13 Oct 2025 According to an Avidity Biosciences media release, the company announced that it has completed a positive pre-BLA meeting with the FDA regarding its upcoming BLA submission of delpacibart zotadirsen (del-zota). The timing for the BLA submission has been updated to Q1 2026 from previous guidance of year end 2025 to ensure the FDA receives additional data to support the chemistry, manufacturing, and controls (CMC) package at time of submission.
  • 10 Sep 2025 Results presented in an Avidity Biosciences media release.

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