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Incannex Healthcare | 8-K: Current report

SEC announcement ·  Feb 28 20:47
Summary by Futu AI
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.
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