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: 26 Nov 2025

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At a glance

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.
07 Oct 2025 According to a LEXEO Therapeutics media release, updates to key components of an Accelerated Approval pathway for LX2006 in Friedreich ataxia (FA) cardiomyopathy, alongside new interim clinical data from ongoing phase I/II studies.

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