Clinical TrialJun 17, 2026, 04:02 PM
Lexeo LX2006 Phase I/II FA Data Published; Pivotal Study On Track
AI Summary
Lexeo Therapeutics announced the publication of key Phase I/II study results for its LX2006 gene therapy in Friedreich ataxia (FA) in JAMA Cardiology. The data, combining 17 participants from two studies, demonstrated LX2006 was generally well-tolerated and showed early signs of efficacy, including sustained improvements in cardiac and neurologic measures, and increased frataxin protein expression. The company is on track to initiate the pivotal SUNRISE-FA 2 study in Q2 2026, with topline data anticipated in the second half of 2027.
Key Highlights
- LX2006 Phase I/II data for Friedreich ataxia published in JAMA Cardiology.
- LX2006 showed 28% mean LVMI improvement at 6 months, 33% at 12 months in some patients.
- Cardiac biopsy data showed increased frataxin protein expression at 3 months in all 8 SUNRISE-FA participants.
- Treatment with LX2006 was generally well-tolerated across 17 participants, with no Grade 3+ SAEs.
- Modified Friedreich Ataxia Rating Scale (mFARS) showed stabilization over time.
- SUNRISE-FA 2 pivotal study is on track to initiate in Q2 2026.
- Topline data from the SUNRISE-FA 2 pivotal study is expected in 2H 2027.
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