原始来源记录
决策级顶线结果
Xenon: X-TOLE2 3期试验 azetukalner 达到FOS主要终点
X-TOLE2 3期试验达到主要终点，25 mg剂量组每月局灶性发作频率中位百分比变化为-53.2%，安慰剂组为-10.4%。公司现计划于2026年第三季度向FDA提交NDA。
关键事实
- 申报时间
- 2026年3月9日 11:36
- 事件
- 顶线结果
- 方向
- 积极
- 来源
- SEC 8-K
- 可信度
- 有来源
- 安慰剂校正25mg
- -42.7%
- 15mg中位百分比变化
- -34.5%
- 25mg中位百分比变化
- -53.2%
- 安慰剂中位百分比变化
- -10.4%
来源摘录
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