Australian pharmaceutical company Incannex Healthcare (ASX:IHL) has begun an independent analysis of the interim study data collected from a phase 2 PsoGAD1 clinical trial assessings its psilocybin-assisted psychotherapy in treating anxiety.
The company says the independent review is being conducted due to the clinical trial achieving its interim milestone of 29 patients completing primary endpoint assessments. This independent review is being conducted by an independent Data Safety Monitoring Board (DSMB) which comprises experts who are not part of the trial.
Incannex reports psilocybin-assisted psychotherapy has shown promise in the treatment of several mental health conditions including general anxiety disorder (GAD). PsiGAD1 was developed in collaboration with the Head of Psychedelic Lab at Monash University and member of the Incannex scientific board, Dr. Paul Liknaitzky.
“The PsiGAD1 trial is supported by a fantastic team of researchers and clinicians and has been an intensive and gratifying project to lead”
This trial is designed to test the safety and efficacy of the psilocybin program in an active placebo-controlled study. The 10-week program includes 2 dosing sessions with either psilocybin or active placebo. This will be followed by an assessment of the safety, efficacy, quality of life and other aspects of mental and physical health.
Commenting on the study, Principal Investigator for the study Dr. Paul Liknaitzky said: “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 (DSMB), and to continuing progress this trial to completion.”
Incannex Healthcare Chief Scientific Officer Dr. Mark Bleackley says: “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.”
To date, Incannex reports 45 participants have been enrolled in the study, with 29 participants having now completed the treatment protocol and main outcome assessment following treatment.
The company says the independence of the DSMB is critical to maintain a blinded study and consequent integrity of the final data read out and analysis. Recommendations from the DSMB will be provided in March.
Incannex also notes the trial is continuing well, with all enrolled patients being retained, and no identified safety concerns. The interim analysis will allow the company 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.
Incannex Healthcare is a clinical stage pharmaceutical development company focused on developing medicinal cannabis products and psychedelic medicine therapies for the treatment of obstructive sleep apnoea (OSA), traumatic brain injury (TBI), concussion, lung inflammation, rheumatoid arthritis, inflammatory bowel disease, anxiety disorders, addiction disorders, and pain.