Throughout the 1950s, psychotherapy was a form of treatment for mental disorders from limited research but with the world having undertaken medical breakthroughs since, pharmaceuticals company Incannex Healthcare (ASX: IHL) is re-visiting the use of psilocybin as a treatment for anxiety through clinical trials in partnership with Monash University.
Psilocybin is better known as magic mushrooms with consumption commonly causing hallucinogenic effects. In the 1950’s and 60’s, psilocybin-assisted psychotherapy research was undertaken where it was able to modulate states of consciousness, perception and mood when combined with psychotherapeutic support.
This new set of trials has been established by Dr Paul Liknaitzky from Monash University and will include a number of major innovations in treatment approach and study design where at least 72 patients will receive specialised forms of psychotherapeutic support before, during and after each psilocybin session.
“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,” said Dr Liknaitzky who will be the Chief Principal Investigator of the trial.
“I’m heartened by the support of IHL, and their ethical approach to supporting 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.
“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.”
Patients will be selected based on their history with General Anxiety Disorder which affects around 6-9% of the global population at some stage in their life. When affected, sufferers find it difficult to control their worry, which may cause significant distress and impairment in social, occupational, or other areas of functioning.
As well as funding the trials to thereby retain intellectual property generated from them, Incannex will conduct the Pre-Investigational New Drug (Pre-IND) meeting with the US Food and Drug Administration shortly. This will provide critical feedback that would impact the application of magic mushrooms for medical use further down the track once Dr Liknaitzky’s planned trials become FDA-compliant.
Dr Liknaitzky is a Research Fellow at Monash University, has earned an Honours in Neuroscience, and a PhD in Psychology from the University of Melbourne. His work examines mechanisms of mental illness and treatment development, primarily within mood disorders and addiction research.
There are currently two other psilocybin research programs being undertaken for depression which have received Breakthrough Designation from the FDA, a classification given that can expedite the development of drugs intended to substantially improve treatment for serious diseases.