Lexeo Therapeutics (LXEO) said Monday that interim data from two clinical trials showed that its gene therapy candidate LX2006 led to "clinically significant" improvements in cardiac biomarkers and functional measures across all dose cohorts for Friedreich ataxia, or FA, cardiomyopathy.
The company said its phase 1/2 trial and Weill Cornell Medicine's phase 1a study also showed that the experimental treatment was associated with increased frataxin protein expression in all participants with cardiac biopsies.
Chief Development Officer Sandi See Tai said the data show LX2006 exceeds the thresholds aligned with the US Food and Drug Administration to support accelerated approval in a registrational study expected to begin in early 2026.
The company said it expects to begin enrollment in Q2 for the registrational study with a potential efficacy readout in 2027.
Lexeo shares were up more than 14% in Monday's premarket activity.
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