Incannex announces results of interim review on Phase 2 program for GAD

Incannex Healthcare announces 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 that the total study will show a statistically significant benefit for the psilocybin treatment arm over the placebo treatment arm. 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 will show a large treatment effect, as measured by a reduction in HAM-A scores compared to the control condition. The trial employs a team of experienced and qualified clinicians and researchers who undergo specialist training before they deliver and assess the treatment. To date, over 45 participants have been enrolled in the study, with 29 participants having now completed the treatment protocol and main outcome assessment following treatment. Treatment of all 72 trial participants is anticipated to be completed in the fourth quarter of 2023. CEO and Managing Director of Incannex, Joel Latham, said: "The results from the interim analysis of Incannex’s Phase 2 clinical trial provide us with encouragement that our PsiGAD psilocybin-assisted psychotherapy treatment protocol has the potential to transform the lives of people suffering from anxiety, I believe IHL is leading the way in research on novel treatments for this debilitating indication. Even though the results must remain blinded until the conclusion of the trial, the confidential review has given us the confidence to commence manufacture of our own psilocybin drug product with the appointment of Catalent, progress planning of our pivotal trials and commence drafting our FDA IND application for the PsiGAD treatment program. The Clinical Psychedelic Lab at Monash University has overseen training of 14 psychotherapists to work on the phase 2 trial, demonstrating that this transformational treatment is scalable to many therapists and patients throughout the world."