原始来源记录
决策级临床试验登记变更
Lexeo 敲定 LX2006 用于 FA 心肌病的 SUNRISE-FA 2 关键方案
Lexeo 已敲定 SUNRISE-FA 2 开放标签关键方案及 SAP，LX2006 以 LVMI 作为 6 个月时的单一主要终点，无安慰剂/假手术组。FDA 确认无需额外非临床桥接研究，公司可使用商业规模 Sf9-杆状病毒工艺。研究启动时间表为 2026 年 Q2，顶线数据预计 2027 年下半年，加速批准 BLA 提交时间为 2028 年上半年。
关键事实
来源摘录
EX-99.1 2 lxeo-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Lexeo Therapeutics Announces Regulatory Update and Registrational Trial Design for LX2006 Gene Therapy in Friedreich Ataxia SUNRISE-FA 2 study parameters include LVMI primary endpoint, 6-month topline efficacy analysis, inclusion criteria focused on abnormal baseline LVMI and open-label trial design BLA supportive manufacturing strategy includes flexible process validation, including reduced PPQ manufacturing batches SUNRISE-FA 2 initiation on track for Q2 2026, with first patient expected to be enrolled by end of June Company to host webcast today at 8:00 AM ET NEW YORK – June 15, 2026 (GLOBE NEWSWIRE) – Lexeo Therapeutics, Inc. (N asdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering novel treatments