Incannex Healthcare Inc. announce that it has completed dosing and treatment protocols for all 72 participants in the PsiGAD-1 clinical trial, the Company?s Phase 2 study evaluating its own psilocybin treatment program for patients with generalized anxiety disorder (GAD). PsiGAD-1 is a randomised triple-blind active-placebo-controlled Phase 2 trial. The primary objective of the study is to determine whether a 7-week program of psilocybin-assisted psychotherapy for GAD is superior to active placebo-assisted psychotherapy in decreasing symptoms of GAD, as measured by the change in the Hamilton Anxiety Rating Scale (HAM-A) from baseline to week 11.

Safety and tolerability were assessed, as well as other secondary objectives of efficacy and quality of life. Incannex commenced the process of drafting an FDA IND application in August 2023 in preparation of the receipt of topline results from the PsiGAD-1 clinical trial, and submission soon thereafter. In March of 2023, Incannex announced the interim analysis for the Phase 2 PsiGAD-1 clinical trial, which predicted a greater than 85% chance that the trial would show statically significant benefit for the psilocybin treatment arm versus the placebo arm at the conclusion of the trial period.

An independent Data Safety Monitoring Board (DSMB) was tasked with confidentially reviewing the data for the first 37 out of 72 trial participants. At that time, the DSMB recommended no adjustments to the original study design or sample size and acknowledged no safety concerns in the operation of the trial.