Lexeo Therapeutics Announces Regulatory Update and Registrational Trial Design for LX2006 Gene Therapy in Friedreich Ataxia
Lexeo Therapeutics has finalized the protocol and statistical analysis plan for SUNRISE-FA 2, the pivotal trial for its gene therapy candidate LX2006 in Friedreich ataxia cardiomyopathy. The study utilizes an open-label design with 13 treated patients and 13 untreated controls, avoiding a placebo arm. The primary endpoint is Left Ventricular Mass Index (LVMI) assessed via MRI at 6 months, with the FDA having removed the cardiac frataxin protein expression co-primary endpoint.
Key figures
- Drug Name
- LX2006
- Phase Of Trial
- Pivotal (Phase 3 equivalent)
- Trial name
- SUNRISE-FA 2
- Enrollment start
- End of June 2026
- Primary endpoint
- Left ventricular mass index (LVMI)
- Total participants
- 26
- Topline data target
- H2 2027
- Control participants
- 13
- Treated participants
- 13
- Bl A submission target
- H1 2028
- Efficacy readout time
- 6 months
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