原始出處紀錄
決策級主要結果 (Topline)
Xenon：X-TOLE2 第三期試驗 azetukalner 達到 FOS 主要終點
X-TOLE2 第三期試驗達到主要終點，25 mg 劑量組每月局灶性發作頻率的中位百分比變化為 -53.2%，安慰劑組為 -10.4%。公司現計劃於 2026 年第三季向 FDA 提交 NDA。
關鍵事實
- 申報時間
- 2026年3月9日 上午11:36
- 事件
- 主要結果 (Topline)
- 方向
- 正面
- 來源
- SEC 8-K
- 可信度
- 有出處
- 安慰劑調整 25mg
- -42.7%
- 15mg 中位百分比變化
- -34.5%
- 25mg 中位百分比變化
- -53.2%
- 安慰劑中位百分比變化
- -10.4%
來源摘錄
EX-99.1 2 d107087dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Xenon Announces Positive Topline Data from Phase 3 X-TOLE2 Study of Azetukalner in Focal Onset Seizures (FOS) • X-TOLE2 met primary endpoint in both dose groups, including -53.2% median percent change (MPC) from baseline in monthly FOS frequency with 25 mg dose compared with -10.4% for placebo (p=0.000000000006) • X-TOLE2 outperformed Phase 2b X-TOLE study, with a placebo-adjusted MPC of -42.7% in 25 mg group in X-TOLE2 compared to -34.6% in 25 mg group in X-TOLE • Azetukalner was generally well-tolerated with a safety profile consistent with X-TOLE study • Xenon anticipates submitting New Drug Application for azetukalner in FOS to the U.S. FDA in Q3 2026 • X-TOLE2 data to be featured in Late Breaking Science oral presen