Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL) chief medical officer Dr Mark Bleakley tells Proactive the company is preparing an application to gain key regulatory approval to begin clinical trials in the US for its psilocybin-assisted psychotherapy development program (Psi-GAD). PsiGAD is a unique and proprietary form of therapy to treat patients with generalised anxiety disorder (GAD). Interim analysis for the Phase 2 Psi-GAD clinical trial in March at Monash University predicted a greater than 85% chance of the trial showing statistically significant benefit for the psilocybin treatment arm versus the placebo arm. Work on the draft IND application comes ahead of final results from the Psi-GAD clinical trial, which are expected in Q4 2023 or Q1 2024.
Incannex preparing psilocybin therapy FDA IND application
