原始出處紀錄
決策級臨床試驗登錄異動
Lexeo 敲定 LX2006 用於 FA 心肌病的 SUNRISE-FA 2 關鍵試驗方案
Lexeo 已敲定 SUNRISE-FA 2 開放標籤關鍵試驗方案與統計分析計畫（SAP），以 LVMI 作為 6 個月單一主要終點，且無安慰劑／假手術對照組。FDA 確認無需額外非臨床橋接研究，公司可使用其商業規模 Sf9-桿狀病毒製程。試驗啟動時程維持 2026 年第 2 季，頂線數據預計 2027 年下半年出爐，並於 2028 年上半年依加速核准途徑提交 BLA。
關鍵事實
來源摘錄
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