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A Phase 1/2 Open-label Dose-escalation Study to Evaluate the Safety, Tolerability, and Biological Activity of EPI-321, an AAVrh74-delivered Epigenetic Editing Therapy in Adult FSHD Patients

Trial Profile

A Phase 1/2 Open-label Dose-escalation Study to Evaluate the Safety, Tolerability, and Biological Activity of EPI-321, an AAVrh74-delivered Epigenetic Editing Therapy in Adult FSHD Patients

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

Latest Information Update: 24 Jul 2026

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At a glance

  • Drugs EPIC 321 (Primary)
  • Indications Facioscapulohumeral muscular dystrophy
  • Focus Adverse reactions; First in man
  • Sponsors EPIC BIO; Epicrispr Biotechnologies

Most Recent Events

  • 20 Jul 2026 Planned primary completion date changed from 31 Mar 2031 to 7 Jul 2027.
  • 07 Jul 2026 Status changed from recruiting to active, no longer recruiting.
  • 07 Jul 2026 According to an Epicrispr Biotechnologies media release, additional clinical data from the study are expected to be presented at the World Muscle Society Annual Congress in September 2026.

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