In a press release this week, Lexeo Therapeutics reported that they have completed enrollment of LX2006 SUNRISE-FA Phase 1/2 trial and reached alignment with FDA on key elements of registrational development plan for LX2006, including accelerated approval pathway with left-ventricular mass index (LVMI) and frataxin protein expression as co-primary registrational endpoints.
The completed enrollment of LX2006 SUNRISE-FA Phase 1/2 trial included four participants treated in cohort 3 and a total of 16 participants dosed with LX2006 to date across SUNRISE-FA and Weill Cornell trials
Lexeo will share new cardiac biopsy data from one participant in cohort 2 and functional scales from three participants in the Lexeo-sponsored SUNRISE-FA trial at ICAR on November 15, 2024.
They have also released a letter to the community summarizing these updates and results, which you can download below.