アクサムセラピューティクスが、ナルコレプシーのENCORE長期第3相試験において、AXS-12が主要評価項目を達成したことを発表

Benzinga · 2024/11/26 07:14

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

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Axsome Therapeutics Reveals AXS-12 Meets Primary Endpoint In ENCORE Long-Term Phase 3 Trial In Narcolepsy