Incannex Healthcare has confirmed that its PsiGAD1 clinical trial has achieved its interim milestone of 29 patients completing primary endpoint assessments.
The trial has been designed to assess Incannex’s psilocybin-assisted psychotherapy programme for the treatment of generalised anxiety disorder (GAD) in an active placebo-controlled study.
The 10-week treatment programme 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.
The study is being conducted at Monash University’s BrainPark under the leadership of Dr Liknaitzky, alongside co-investigators Professor Suresh Sundram, Head of the Dept of Psychiatry, Monash and Professor Murat Yücel, Director of BrainPark.
The company has stated that the interim analysis will allow it to make key decisions on regulatory strategy and plan pivotal studies, while continuing to collect data from the PsiGAD1 trial, and that patient recruitment is ongoing towards fulfilling the complete study cohort of 72 patients.
Principal Investigator on the trial, Dr Paul Liknaitzky, commented: “The PsiGAD1 trial is supported by a fantastic team of researchers and clinicians and has been an intensive and gratifying project to lead.
“I look forward to the recommendations of the Data Safety Monitoring Board, and to continuing to progress this trial to completion.”
For the study, Dr Liknaitzky has recruited a team of experienced and qualified clinicians and researchers to undergo specialist training, and deliver and assess the treatment.
So far, 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 is being conducted by an independent Data Safety Monitoring Board (‘DSMB’) comprising experts who are not part of the trial.
Incannex emphasised that the independence of the DSMB is critical to maintain a blinded study and for the consequent integrity of the final data readout and analysis.
Recommendations from the DSMB will be provided in March 2023.
Incannex Chief Scientific Officer, Dr Mark Bleackley, stated: “Monash University is a major globally recognised and highly innovative university. Dr Liknaitzky and his team are at the forefront of psychedelic research and development.
“Incannex continues to benefit from the academic rigour that Monash University and Dr Liknaitzky bring to the development of this therapy, which should assist our ambitions to be amongst the first companies in the world to provide a proprietary psychedelic therapy to the public.
“We look forward to providing a further update to our stakeholders following the recommendations from the DSMB.”
