Incannex teams with Monash University to study safety and efficacy of ‘magic mushroom’ treatment

Incannex Healthcare is partnering with Monash University for a rigorous scientific study into the safety and efficacy of psilocybin-assisted psychotherapy in the treatment of anxiety.

Psilocybin, a psychedelic compound found in so-called “magic mushrooms”, has been used in spiritual ceremonies for hundreds of years and was studied in tens of thousands of individuals in psychedelic research in the 1950s and 1960s.

While that work stalled during the “War on Drugs,” in the past decade or so it has been revitalised, with an explosion of interest at respected academic institutions around the world in using the compounds to treat serious problems including depression, alcoholism and smoking addiction.

The Incannex/Monash clinical trial will be led by Monash research fellow Paul Liknaitzky, a PhD who specialises in the treatment of mental illness and mood disorders, with support from leading researchers and clinicians at Monash, across Australia, and around the world.

It will be a phase 2 randomised double-blind active-placebo-controlled trial – the “gold standard” in clinical research – to study psilocybin in the treatment of Generalised Anxiety Disorder, a problem that affects as many as three per cent of the population in developed countries like Australia and the USA each year.

The trial will involve at least 72 patients, making it the largest psychedelic research and development project in Australia, and one that is expected to have a substantial impact on the field globally.

The treatment will be delivered within BrainPark, Monash’s state-of-the-art research platform at Monash’s Turner Institute for Brain and Mental Health and Biomedical Imaging Facility, with patients dosed by experienced clinicians who have undergone substantive training in psilocybin-assisted psychotherapy, Incannex says.

Participants will also receive specialised forms of psychotherapeutic support before, during and after each psilocybin session.

The company intends to make the study compliant with US Food and Drug Administration protocols, and plans to call a Pre-IND meeting with the FDA as soon as possible to discuss study protocols.

The Incannex-funded study will prioritise scientific independence, rigour and patient outcomes, Incannex says. Importantly, all developed intellectual property from the clinical trial program is retained by IHL.

‘A major leap forward’

“This trial, and the associated partnership between IHL and Monash University, represents a major leap forward for psychedelic research and development in Australia, and will have a substantial impact on the field globally,” Dr Liknaitzky says.

“I’m heartened by the support of IHL, and their ethical approach to support scientifically independent and patient-focused treatment development.

“I’m inspired by our esteemed and brilliant research and clinical team at Monash, and the strong support from the University.

“And I’m confident that we will conduct a highly rigorous, patient-focused, world-class trial to assess the safety of this treatment approach for people dealing with severe anxiety.

“Given the early yet highly promising results from other psilocybin trials for different conditions this treatment – alongside innovations we will develop – may deliver a substantial step forward in the treatment of anxiety disorders.”