Update from Lexeo Therapeutics
On April 7, 2025, Lexeo Therapeutics announced positive interim data from the Phase 1/2 study of their gene addition therapy for FA cardiomyopathy. They reported that in both the Lexeo-sponsored SUNRISE-FA Phase 1/2 clinical trial and the Weill Cornell Medicine investigator-initiated Phase 1A trial, treatment with LX2006 was associated with clinically significant improvements in cardiac biomarkers and functional measures, and increased frataxin protein expression was observed in all participants with cardiac biopsies. Among the six participants with abnormal baseline left ventricular mass index (LVMI, a measurement of the size and thickness of the left ventricle of the heart), five had a greater than 10% improvement in LVMI by the 12-month visit or sooner.
Lexeo has obtained alignment with the FDA on key parameters related to the LX2006 planned registrational study and is expected to initiate this study in early 2026.
