Incannex Healthcare (ASX: IHL) has announced that the PsiGAD1 clinical trial to assess its psilocybin-assisted psychotherapy for the treatment of generalised anxiety disorder (GAD) has achieved an interim milestone of 29 patients completing primary endpoint assessments.
PsiGAD1 was developed as a collaborative effort between Incannex and Dr Paul Liknaitzky at Melbourne’s Monash University.
The trial is designed to assess the safety and efficacy of the company’s unique psilocybin program in an active placebo-controlled study.
This 10-week treatment program includes two dosing sessions with either psilocybin or active placebo, and assesses safety, efficacy, quality of life and other aspects of mental and physical health.
It is being conducted at the university’s BrainPark under the leadership of Dr Paul Liknaitzky, alongside co-investigators Professor Suresh Sundram (head of the Department of Psychiatry) and Professor Murat Yücel (director of BrainPark).
To-date, 45 participants have been enrolled, and 29 have completed the treatment protocol and main outcome assessment following treatment.
Data analysis
Analysis of interim study data is being conducted by independent data monitoring experts who are not part of the trial. Results from this analysis will be available for public release in March 2023.
The analysis will allow Incannex to make key decisions on regulatory strategy in parallel with planning pivotal studies while continuing to collect data from the trial.
Incannex has already completed a pre-investigational new drug (pre-IND) meeting with the US Food and Drug Administration (FDA).
The company intends to open an IND with FDA utilising data from PsiGAD1.
Inadequate treatment
Industry research shows treatment of GAD with current medications and therapies remains inadequate, with less than half of patients achieving remission.
Psilocybin-assisted psychotherapy by contrast, has shown promise in the treatment of several mental health conditions.
Incannex chief scientific officer Dr Mark Bleackley said the company was fortunate to be working with Monash University.
“Dr Liknaitzky and his team are at the forefront of psychedelic research and development, and we continue to benefit from the academic rigour they bring to the development of this therapy,” he said.
“We expect it will assist our ambitions to be amongst the first companies in the world to provide a proprietary psychedelic therapy to the public.”
