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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

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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: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 13 Jan 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

  • 16 Dec 2025 Planned number of patients changed from 9 to 12.
  • 05 Aug 2025 According to an Epicrispr Biotechnologies media release, the first patient has been dosed in this trial. Initial data is expected in early 2026.
  • 11 May 2025 Status changed from not yet recruiting to recruiting.

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