1차 출처 기록
결정급탑라인 결과
Xenon: X-TOLE2 3상 azetukalner, FOS에서 1차 평가변수 충족
X-TOLE2 3상 시험은 25 mg 용량에서 월간 국소발작 빈도의 중앙값 백분율 변화 -53.2%로 1차 평가변수를 충족했으며, 위약군은 -10.4%였습니다. 회사는 2026년 3분기에 FDA에 NDA를 제출할 계획입니다.
핵심 사실
출처 발췌
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