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Phase IA and IB Study of AAVrh.10hFXN Gene Therapy for the Cardiomyopathy of Friedreich's Ataxia

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Trial Profile

Phase IA and IB Study of AAVrh.10hFXN Gene Therapy for the Cardiomyopathy of Friedreich's Ataxia

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 28 Aug 2026

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At a glance

  • Drugs LX 2006 (Primary) ; Prednisone (Primary)
  • Indications Cardiomyopathies; Friedreich's ataxia
  • Focus Adverse reactions

Most Recent Events

  • 12 Aug 2026 According to a LEXEO Therapeutics media release , potential BLA submission under accelerated approval pathway planned in first half of 2028.
  • 07 Oct 2025 Results presented in a LEXEO Therapeutics media release
  • 07 Oct 2025 According to a LEXEO Therapeutics media release , U.S. Food and Drug Administration (FDA) open to pooling data from ongoing phase I/II studies of LX2006 with pivotal data to support a Biologics License Application (BLA) for Accelerated Approval. In discussions to date, there have been no changes to the previously disclosed alignment with the FDA on key parameters related to the LX2006 planned registrational study.

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