Incannex Healthcare (ASX: IHL) has partnered with Monash University to undertake a “world first” clinical trial using psilocybin-assisted psychotherapy to treat generalised anxiety disorder.
According to Incannex, evidence is building on using psychoactive molecule psilocybin to modulate consciousness states, cognition, perception, and mood.
Psilocybin is found naturally in several mushrooms.
“When combined with specialised forms of psychotherapeutic support, psilocybin can be both a safe and highly effective mental health treatment,” the company stated.
Psychedelic research was previously conducted in the 1950s and 1960s with tens of thousands of individuals participating.
Incannex noted that many of these studies found “substantial improvements” in anxiety, depression, alcohol use disorder and quality of life.
Additionally, more recent research has had similar results indicating psilocybin-assisted psychotherapy may be affective in helping with these same conditions as well as other addictions and mental health disorders.
Incannex expects that if results prove positive from a number of trials worldwide, registration of psilocybin-assisted psychotherapy as a prescription could occur within the next five years.
Psilocybin-assisted psychotherapy trial at Monash
The US Food and Drug Administration-compliant trial will be a “world first” in using psilocybin in treating generalised anxiety disorder.
Two other companies are working towards using psilocybin in therapy for depression-related illnesses and both have received FDA “breakthrough” status, which gives them an expedited review process over their work.
Compass Pathways is one of those companies and it has a a market cap of US$1.97 billion after being backed by Paypal’s Peter Thiel and recently listing on the NASDAQ.
With support from Australian and international researchers, Monash research fellow Dr Paul Liknaitzky will lead the phase 2 trial in evaluating the safety and efficacy of psilocybin-assisted psychotherapy in generalised anxiety disorder.
Dr Liknaitzky is also a member of Incannex’s medical advisory board and has adjunct or honorary appointments at St Vincent’s Hospital, Macquarie University, and the University of Melbourne.
His own research led to an honours in neuroscience and a PhD in psychology with work in field involving examining mechanisms of mental illness and treatment development.
In addition to heading up the Incannex and Monash psilocybin study, Dr Liknaitzky is establishing a “rigorous” research program at Monash that seeks to evaluate the therapeutic effects of psychedelic medicine.
More than 70 patients will be recruited for the trial which will comprise “a number of innovations” in treatment approach and design.
Treatment will include a number of psilocybin dosing sessions in parallel with a specialised psychotherapy program.
All those involved in the program are qualified clinicians with “substantive training” in psilocybin-assisted psychotherapy.
Incannex retains IP
Upon completion of the study, Incannex will retain all intellectual property that was developed. However, as part of the partnership with Monash, both organisations will share data to advance research and development and create a “promising treatment approach”.
“This trial, and the associated partnership between Incannex and Monash, represents a major leap forward for psychedelic research and development in Australia, and will have a substantial impact on the field globally,” Dr Liknaitzky said.
“I’m heartened by the support of Incannex, and their ethical approach to supporting scientifically-independent and patient-focused treatment development.”
Dr Liknaitzky added he was confident the trial would be “highly rigorous, patient focused” and “world class” to assess this treatment approach for people 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,” he said.
Generalised anxiety disorder
Individuals are diagnosed with a generalised anxiety disorder if they have excessive anxiety and worry more days than not for at least six months – and it is not restricted to any particular environmental circumstances.
Symptoms are usually feelings of persistent and excessive worry, nervousness, restlessness, difficulty concentrating as well as a range of somatic manifestations.
Many generalised anxiety sufferers are unable to control their worry, which can cause distress and impairment in social, occupational, or other areas of functioning.
“As with other mood disorders, successful treatment of generalised anxiety disorder remains inadequate, with less than half of patients achieving remission following evidence-based treatment, alongside high relapse rates, and substantial treatment side-effects or cost,” Incannex noted.