Incannex announces topline results from Phase 2 Psi-GAD1 trial

Incannex Healthcare announces 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 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, representing a decrease of 9.2 points over the placebo group. 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. “We are thrilled with the results from our initial PsiGAD trial,” said President and CEO Joel Latham. “This is the first time psilocybin has been investigated for treatment of generalised anxiety disorder, and the reduction in HAM-A scores we have observed are far greater those reported from trials on established medicines for treatment of anxiety.”