Sunday, July 13, 2025
Lexeo Therapeutics Announces FDA Breakthrough Therapy Designation for LX2006 in Friedreich Ataxia
07/07/2025 ;Lexeo Therapeutics (Nasdaq: LXEO) has achieved a significant milestone as its drug candidate LX2006 received FDA Breakthrough Therapy designation for treating Friedreich ataxia (FA). The designation was based on promising interim clinical data from Phase I/II trials showing meaningful improvements in cardiac biomarkers and functional measures.
The drug has demonstrated clinically significant improvements in cardiac and neurologic functional measures, with increased frataxin expression observed in all cardiac biopsy participants at three months post-treatment. To date, 17 participants have been treated across two trials. The company plans to initiate a registrational study by early 2026.
Additionally, LX2006 has been selected for the FDA's Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) program, aimed at facilitating faster patient access to promising therapies.
