Incannex says independent data review commences for PsiGAD1 trial

Incannex Healthcare announced that the PsiGAD1 clinical trial, designed to assess Incannex’s psilocybin-assisted psychotherapy for the treatment of generalised anxiety disorder, has achieved its interim milestone of 29 patients completing primary endpoint assessments. Independent analysis of the interim study data has commenced. Treatment of GAD with currently accepted medications and therapies remains inadequate, with less than half of patients achieving remission. Psilocybin-assisted psychotherapy has shown promise in the treatment of several mental health conditions. PsiGAD1 was developed in collaboration with Dr Paul Liknaitzky, Head of the Clinical Psychedelic Lab at Monash University and a member of the Incannex scientific advisory board. The trial is designed to assess the safety and efficacy of the Company’s unique psilocybin program in an active placebo-controlled study. The 10-week treatment program includes two dosing sessions with either psilocybin or active placebo. Safety, efficacy, quality of life, and other aspects of mental and physical health are assessed. To date, 45 participants have been enrolled in the study, with 29 participants having now completed the treatment protocol and main outcome assessment following treatment. The interim analysis of the study data to date, conducted by an independent Data Safety Monitoring Board comprising experts who are not part of the trial, has commenced. The independence of the DSMB is critical to maintain a blinded study and consequent integrity of the final data readout and analysis. Recommendations from the DSMB will be provided in March 2023, at which time the Company will provide another public announcement. The trial continues to progress well and on time, with retention of all participants who have been enrolled. The trial team have identified no safety concerns to date. The interim analysis will allow Incannex to make key decisions on regulatory strategy and, in parallel, planning of pivotal studies, while continuing to collect data from the PsiGAD1 trial. Patient recruitment is ongoing towards fulfilling the complete study cohort of 72 patients.