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

Benzinga · 11/26 12:14
  • 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