Axsome Therapeutics Reveals AXS-12 Meets Primary Endpoint In ENCORE Long-Term Phase 3 Trial In Narcolepsy
Axsome Therapeutics Reveals AXS-12 Meets Primary Endpoint In ENCORE Long-Term Phase 3 Trial In Narcolepsy
Axsome Therapeutics公布ENCORE长期3期试验中AXS-12达到嗜睡症主要终点
- AXS-12 statistically significantly reduced the frequency of cataplexy attacks compared to placebo (p=0.017, primary endpoint)
- Statistically significant improvement in cognition compared to placebo (p=0.011, NSAQ)
- Statistically significant improvement in narcolepsy overall compared to placebo (p=0.024, PGI-C)
- Cataplexy response (≥50% improvement) achieved by 72% of patients at 1 month and 82% at 6 months
- Improvement in excessive daytime sleepiness (EDS), assessed by the CGI-C, achieved by 84% of patients at 1 month and 78% at 6 months
- Improvement in narcolepsy overall, assessed by the CGI-C, achieved by 90% of patients at 1 month and 90% at 6 months
- Well-tolerated with long-term safety profile consistent with previously completed trials and no new safety signals detected
- NEW YORK, Nov. 26, 2024 (GLOBE NEWSWIRE) -- Axsome The
- 从统计学上讲，与安慰剂相比，AXS-12 显著降低了瘫痪发作的频率（p=0.017，主要终点）
- 与安慰剂相比，认知能力有统计学上的显著改善（p=0.011，NSAQ）
- 与安慰剂相比，发作性睡病的总体改善具有统计学意义（p=0.024，PGI-C）
- 72% 的患者在 1 个月时达到 Cataplexy 反应（改善 ≥ 50%），82% 的患者在 6 个月时达到
- 根据CGI-C的评估，84％的患者在1个月时改善了日间过度嗜睡（EDS），78％的患者在6个月时改善了日间过度嗜睡（EDS）
- 根据CGI-C的评估，90％的患者在1个月时实现了发作性睡病的总体改善，90％的患者在6个月时实现了发作性睡病的改善
- 耐受性良好，长期安全性与先前完成的试验一致，未检测到新的安全信号
- 纽约，2024 年 11 月 26 日（环球新闻专线）— Axsome The
资讯热榜
更新时间