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Compass Pathways Announced Topline Results From An Open-label Phase 2 Study Of COMP360 Psilocybin Treatment For Post-Traumatic Stress Disorder, The Study Met Its Primary Safety Endpoint And Available Secondary Efficacy Endpoints

Compass Pathways Announced Topline Results From An Open-label Phase 2 Study Of COMP360 Psilocybin Treatment For Post-Traumatic Stress Disorder, The Study Met Its Primary Safety Endpoint And Available Secondary Efficacy Endpoints

Compass Pathways 公布了一项针对 COMP360 psilocybin 治疗创伤后应激障碍的开放标签 2 期研究的主要结果,该研究达到了其主要安全终点和可用的次要疗效终点
Benzinga ·  05/08 18:41
  • Study met primary safety endpoint; administration was well tolerated, with no serious adverse events observed
  • Early and clinically meaningful improvement from baseline in mean CAPS-5 total score (29.5 point reduction at week 12), with change from baseline in mean SDS total score (14.4 point reduction at week 12)
  • 81.8% response (reduction of ≥ 15 points in CAPS-5 score), 63.6% remission (total CAPS-5 ≤ 20) rates at week 4 with 77.3% response and 54.5% remission at week 12
  • Measures of symptom scores relative to baseline improved following a single 25mg dose administered with psychological support (n=22)
  • 研究达到了主要安全终点;给药耐受性良好,未观察到严重的不良事件
  • CAPS-5 平均总分与基线相比有早期临床意义的改善(第 12 周降低 29.5 分),SDS 的平均总分与基线相比有所变化(第 12 周降低 14.4 分)
  • 81.8% 的回复率(CAPS-5 分数降低 ≥ 15 分),第 4 周的缓解率为 63.6%(总 CAPS-5 ≤ 20),反应率为 77.3%,第 12 周缓解率为 54.5%
  • 在心理支持下给予单剂量25mg后,相对于基线的症状评分指标有所改善(n=22)

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