Clinical TrialJun 15, 2026, 07:01 AM
Lexeo Finalizes Pivotal SUNRISE-FA 2 Trial Protocol for LX2006
AI Summary
Lexeo Therapeutics, Inc. announced the finalization of the SUNRISE-FA 2 pivotal trial protocol and statistical analysis plan for its gene therapy candidate LX2006. This milestone establishes a clear path for evaluating LX2006 in Friedreich ataxia (FA) cardiomyopathy, with the goal of submitting a Biologics License Application (BLA) under the accelerated approval pathway in 2028. The trial initiation is on track for Q2 2026, with the first patient expected to be enrolled by the end of June. The study will be an open-label trial with 13 treated participants and 13 untreated controls, focusing on Left ventricular mass index (LVMI) as the primary endpoint.
Key Highlights
- Lexeo Therapeutics finalized SUNRISE-FA 2 pivotal trial protocol and statistical analysis plan (SAP) for LX2006.
- Company targets Biologics License Application (BLA) submission under accelerated approval pathway in 2028.
- SUNRISE-FA 2 initiation is on track for Q2 2026, with first patient enrollment expected by end of June.
- Primary endpoint is Left ventricular mass index (LVMI), with topline efficacy readout at 6 months post-treatment.
- Study design is open-label, with 13 treated participants and 13 untreated controls, with crossover eligibility.
- BLA supportive manufacturing strategy includes flexible process validation and reduced PPQ manufacturing batches.
- Topline data readout for SUNRISE-FA 2 is expected in the second half of 2027.
- Lexeo Therapeutics will host a webcast today, June 15, 2026, at 8:00 AM ET.
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