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Incannex Healthcare | 8-K: Current report

Incannex Healthcare | 8-K:重大事件

SEC announcement ·  02/28 20:47
牛牛AI助理已提取核心訊息
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.報告了其2期PSI-GAD1臨床試驗的積極結果,該試驗評估了迷幻藥治療廣泛性焦慮症(GAD)的療效。該試驗是與莫納什大學臨床迷幻實驗室合作開發的,達到了其主要終點,顯示與接受安慰劑心理治療的參與者相比,接受迷幻藥輔助治療的參與者的漢密爾頓焦慮評分量表(HAM-A)分數在統計學上顯著降低。結果表明,psilocybin組中有44%的患者的焦慮評分下降了至少50%,27%的患者實現了完全的疾病緩解,比率明顯高於安慰劑組。Incannex還宣佈其 PSX-001 psilocybin藥物產品已完成,並計劃向美國食品藥品管理局提交多地點2B期試驗的研究性新藥(IND)申請。該公司強調了psilocybin療法在改善數百萬GAD患者生活質量方面的潛力,試驗中沒有報告嚴重的不良事件。
2024年2月28日,Incannex Healthcare Inc.報告了其2期PSI-GAD1臨床試驗的積極結果,該試驗評估了迷幻藥治療廣泛性焦慮症(GAD)的療效。該試驗是與莫納什大學臨床迷幻實驗室合作開發的,達到了其主要終點,顯示與接受安慰劑心理治療的參與者相比,接受迷幻藥輔助治療的參與者的漢密爾頓焦慮評分量表(HAM-A)分數在統計學上顯著降低。結果表明,psilocybin組中有44%的患者的焦慮評分下降了至少50%,27%的患者實現了完全的疾病緩解,比率明顯高於安慰劑組。Incannex還宣佈其 PSX-001 psilocybin藥物產品已完成,並計劃向美國食品藥品管理局提交多地點2B期試驗的研究性新藥(IND)申請。該公司強調了psilocybin療法在改善數百萬GAD患者生活質量方面的潛力,試驗中沒有報告嚴重的不良事件。

譯文內容由第三人軟體翻譯。


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