Lexeo Therapeutics advances LX2006 trial toward 2026 initiation
The biotechnology company expects to enroll its first patient in the SUNRISE-FA 2 pivotal trial by the end of June 2026.
Lexeo Therapeutics (LXEO), a clinical-stage biotechnology company, finalized the protocol and statistical analysis plan for its SUNRISE-FA 2 pivotal trial. The milestone follows a period of submission and feedback from regulators reported in the first quarter of 2026.
The company is now on track to initiate the study in the second quarter of 2026. Lexeo said it expects to enroll the first patient by the end of June 2026.
Regulatory adjustments streamlined the trial's design. The FDA recommended removing the cardiac frataxin protein expression co-primary endpoint because proof of mechanism is no longer necessary. Additionally, the FDA confirmed that no further nonclinical bridging studies are required for pediatric cohorts, which allows the company to use its optimized Sf9-baculovirus manufacturing process.
Lexeo reported new evidence regarding the efficacy of LX2006. The company noted an annualized difference in neurological functional progression of 2.3 points per year compared to a propensity-matched control.
Operational readiness for the trial is complete, as clinical drug product for LX2006 has been manufactured at commercial scale and is available for immediate patient dosing.
Lexeo expects to receive topline data for SUNRISE-FA 2 in the second half of 2027. The company plans to submit a biologics license application under the accelerated approval pathway in the first half of 2028.