Axsome Meets Primary Endpoint in ENCORE Long-Term Phase 3 Trial in Narcolepsy

 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

https://www.globenewswire.com/news-release/2024/11/26/2987364/33090/en/Axsome-Therapeutics-Announces-AXS-12-Achieves-Primary-Endpoint-in-ENCORE-Long-Term-Phase-3-Trial-in-Narcolepsy.html