Creso Pharma’s (ASX: CPH) Canadian acquisition target Halucenex Life Sciences has expanded the recruitment of a phase II clinical trial of psychedelic psilocybin to include non-veteran sufferers of treatment-resistant post-traumatic stress disorder (PTSD).
The trial was originally designed to test the efficacy of psilocybin (the active ingredient in magic mushrooms) on veterans and first responders with treatment-resistant PTSD.
Creso’s move to include non-veterans follows an “overwhelming” amount of enquiries received by Halucenex from members of the general public who also suffer from debilitating mental health conditions and are seeking alternative treatments.
The company anticipates the addition of non-veterans to the trial will allow it to collate an additional data set, providing real world examples of the efficacy of psilocybin when used as an alternative treatment route.
Data from the trial will be used to progress discussions with potential partners including drug developers and large pharmaceutical companies, as well as insurance providers and regulatory bodies to further cement Halucenex’s position as a first mover in the emerging psychedelics medicines space.
Halucenex chief executive officer Bill Fleming said the non-veteran participants would add numerous benefits to the trial.
“Following various regulatory shifts in the US and the exacerbating effects of COVID-19 on mental health conditions across the population, it is becoming more and more apparent that psychedelic treatments could become mainstream in the near future,” he said.
“To include every day people in our research and development will provide us with examples of how psilocybin can be used more broadly to treat mental health issues.”
Creso non-executive chairman Adam Blumenthal said the expanded trial would assist Halucenex’s efforts to become a “best-in-class provider”.
“Halucenex’s management team continues to take steps towards creating psychedelic compounds and therapeutics that can be used for veterans and first responders, as well as everyday individuals,” he said.
“Broadening the clinical trial participant scope is a very promising development that will lay a strong foundation [for Halucenex] as it pushes towards becoming a best-in-class provider of cannabis, cannabinoids and psychedelic alternative medicines to meet the growing need for treatments to improve wellbeing.”
Halucenex expects to begin the phase II trial following the receipt of a Controlled Drugs and Substances Dealer’s Licence from Health Canada as well as clinical trial authorisation.
Discussions with Health Canada are at an advanced stage and the company anticipates it will secure the licence in the near future.
PTSD is a psychological response to the experience of intense traumatic events, including those which threaten lives.
For a military veteran, that trauma may relate to direct combat duties, being in a dangerous war zone, or taking part in peacekeeping missions under difficult and stressful conditions.
According to Department of Veterans’ Affairs statistics, around 10% of the general population are likely to develop PTSD at some point in their lives, compared to up to 20% of veterans (depending on the nature of their work and deployment history).
Among current-serving military members, about 8% have experienced PTSD in a given year, compared to 5% of the general population.
Mr Fleming said expanding the scope of the trial to include veterans, first responders and non-veterans would add to the growing body of evidence for psychedelic-based medicines, and assist Halucenex as it progresses research and licencing agreements in North America and other regions.