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On February 28, 2024, Incannex Healthcare Inc. reported positive topline results from its Phase 2 Psi-GAD1 clinical trial, which evaluated the efficacy of psilocybin in treating generalized anxiety disorder (GAD). The trial, developed in partnership with Monash University's Clinical Psychedelic Lab, met its primary endpoint, showing a statistically significant reduction in the Hamilton Anxiety Rating Scale (HAM-A) score among participants receiving psilocybin-assisted therapy compared to those receiving psychotherapy with placebo. The results indicated that 44% of patients in the psilocybin group experienced at least a 50% reduction in anxiety scores, and 27% achieved full disease remission, rates significantly higher than the placebo group. Incannex also announced the completion of its PSX-001 psilocybin drug product and plans to submit an Investigational New Drug (IND) application to the FDA for a multi-site Phase 2B trial. The company highlighted the potential of psilocybin therapy to improve the quality of life for millions suffering from GAD, with no serious adverse events reported in the trial.
On February 28, 2024, Incannex Healthcare Inc. reported positive topline results from its Phase 2 Psi-GAD1 clinical trial, which evaluated the efficacy of psilocybin in treating generalized anxiety disorder (GAD). The trial, developed in partnership with Monash University's Clinical Psychedelic Lab, met its primary endpoint, showing a statistically significant reduction in the Hamilton Anxiety Rating Scale (HAM-A) score among participants receiving psilocybin-assisted therapy compared to those receiving psychotherapy with placebo. The results indicated that 44% of patients in the psilocybin group experienced at least a 50% reduction in anxiety scores, and 27% achieved full disease remission, rates significantly higher than the placebo group. Incannex also announced the completion of its PSX-001 psilocybin drug product and plans to submit an Investigational New Drug (IND) application to the FDA for a multi-site Phase 2B trial. The company highlighted the potential of psilocybin therapy to improve the quality of life for millions suffering from GAD, with no serious adverse events reported in the trial.
2024年2月28日，Incannex Healthcare Inc.报告了其2期PSI-GAD1临床试验的积极结果，该试验评估了迷幻药治疗广泛性焦虑症（GAD）的疗效。该试验是与莫纳什大学临床迷幻实验室合作开发的，达到了其主要终点，显示与接受安慰剂心理治疗的参与者相比，接受迷幻药辅助治疗的参与者的汉密尔顿焦虑评分量表（HAM-A）分数在统计学上显著降低。结果表明，psilocybin组中有44％的患者的焦虑评分下降了至少50％，27％的患者实现了完全的疾病缓解，比率明显高于安慰剂组。Incannex还宣布其 PSX-001 psilocybin药物产品已完成，并计划向美国食品药品管理局提交多地点2B期试验的研究性新药（IND）申请。该公司强调了psilocybin疗法在改善数百万GAD患者生活质量方面的潜力，试验中没有报告严重的不良事件。
2024年2月28日，Incannex Healthcare Inc.报告了其2期PSI-GAD1临床试验的积极结果，该试验评估了迷幻药治疗广泛性焦虑症（GAD）的疗效。该试验是与莫纳什大学临床迷幻实验室合作开发的，达到了其主要终点，显示与接受安慰剂心理治疗的参与者相比，接受迷幻药辅助治疗的参与者的汉密尔顿焦虑评分量表（HAM-A）分数在统计学上显著降低。结果表明，psilocybin组中有44％的患者的焦虑评分下降了至少50％，27％的患者实现了完全的疾病缓解，比率明显高于安慰剂组。Incannex还宣布其 PSX-001 psilocybin药物产品已完成，并计划向美国食品药品管理局提交多地点2B期试验的研究性新药（IND）申请。该公司强调了psilocybin疗法在改善数百万GAD患者生活质量方面的潜力，试验中没有报告严重的不良事件。
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