Incannex Healthcare Inc. announced positive topline results from its Phase 2 Psi-GAD1 clinical trial of psilocybin in generalised anxiety disorder (GAD). The trial met its primary endpoint, demonstrating a large clinical effect in the psilocybin treatment group over the placebo group. The trial protocol and treatment design were developed in partnership with the Clinical Psychedelic Lab at Monash University, led by Dr Paul Liknaitzky.

The reduction in HAM-A score from baseline in the psilocybin group was 12.8 points, from 29.5 at baseline to 16.8 at week 11 (6 weeks following the final dosing session), representing a decrease of 9.2 points over the placebo group (-12.8 psilocybin vs. -3.6 placebo; p<0.0001). 44% of patients in the psilocybin group showed a clinically meaningful improvement of at least 50% reduction in anxiety score from baseline; a ?response rate?

more than four times higher than that of the placebo group. 27% of patients in the psilocybin group achieved full disease remission; a rate more than five times higher than that of psychotherapy with placebo. Psilocybin within the context of PsiGAD psychotherapy was observed to be well-tolerated, with only mild and moderate adverse events (AEs) reported.

The reported AEs were consistent with the known effects of the drug. No serious or severe adverse events were observed. Only one person of the 73 participants withdrew from the trial during the 7-week treatment program.