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Interim review of proprietary PsiGAD clinical trial data indicates no safety concerns and projects a statistically significant benefit for the psilocybin arm versus the placebo arm in those participants who have completed the treatment
Highlights: Interim analysis of study data to date indicates that there is a greater than 85% chance (>85%, alpha error probability 0.05) of the study showing
About this update from Incannex Healthcare Inc.
[{"type":"text","content":"Highlights: Interim analysis of study data to date indicates that there is a greater than 85% chance (>85%, alpha error probability 0.05) of the study showing a statistically significant benefit for the psilocybin treatment arm versus the placebo treatment arm at the conclusion of the study period.An independent Data Safety Monitoring Board (DSMB) has reviewed data from Incannex’s ongoing Phase 2 “PsiGAD” clinical trial and recommends no changes to study design.The trial team and DSMB have identified no safety concerns to date. MELBOURNE, Australia, March 15, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a pharmaceutical cannabinoid and psychedelic medicines company, is pleased to announce results of an interim review of the conduct, safety and data from its ongoing Phase 2 clinical trial assessing its proprietary psilocybin-assisted psychotherapy program for Generalised Anxiety Disorder (‘GAD’), known as “PsiGAD”. IHL has reviewed the interim data from the first 29 participants to complete the treatment protocol and completed a conditional power analysis using the interim data to model and project total study data. Given the strong results to date, the company found that there is a high probability (greater than 85% - alpha error 0.05 or 95% confidence level) that the total study will show a statistically significant benefit for the psilocybin treatment arm over the placebo treatment arm. This projection is made by assuming the effect size observed in the interim analysis for 29 participants is representative of the effect size through the remaining 43 participants. The end point used in this modelling was a reduction in Hamilton Anxiety Rating Scale (HAM-A) score at 11 weeks relative to baseline, which is the primary endpoint in the trial. A review was also conducted by an independent DSMB, which reviewed the available data from the first 37 out of 72 participants. The DSMB recommended no adjustments to the original study design or sample size. IHL announced the original study on December 8, 2020, under the heading: Incannex partners with Monash University to conduct a world-first clinical trial: Psilocybin-assisted psychotherapy in the treatment of Generalised Anxiety Disorder. The study design is based on the hypothesis that psilocybin-assisted psychotherapy wil...