Incannex Healthcare receives pre-IND guidance and ethics approval to begin phase 2a psychedelic trial
Incannex Healthcare says this will be the first trial of its kind in the world to evaluate the safety and efficacy of psilocybin in treating a primary anxiety disorder.
Psychedelic and cannabinoid biotech company Incannex Healthcare (ASX: IHL) has received ethics approval to proceed with a phase 2a psilocybin-assisted psychotherapy clinical trial for patients with crippling generalised anxiety disorder.
Approval was received from Monash University Human Research Ethics Committee and will allow Incannex to begin importing the drug for the trial and finalise the site infrastructure.
Led by Monash head of clinical psychedelic research Dr Paul Liknaitzky, the trial will be the first in the world to examine the safety and efficacy of psilocybin for any primary anxiety disorder.
It will also be the largest psychedelic trial ever conducted in Australia, recruiting 72 participants who will experience two psilocybin or active-placebo dosing sessions and up to 11 non-drug, specialist psychotherapy sessions over a 10-week period.
It will be conducted at state-of-the-art neuroscience research platform BrainPark, located within Monash University’s Turner Institute for Brain and Mental Health.
Incannex said the primary endpoints would be safety, efficacy and tolerability, while secondary ones would be quality of life, functional impairment and comorbidities.
The project puts Incannex in the class of psychedelic companies like MindMed Inc and Compass Pathways, both of which are listed on the Nasdaq with valuations exceeding US$1B.
Incannex is also pursuing its own Nasdaq listing after submitting its registration document with the SEC. Roth Capital has been engaged to assist in the listing process.
Therapist training program
The phase 2a trial will include a range of treatment innovations alongside the development of a specialised therapist training program.
Dr Liknaitzky said the study had been approved to investigate the option for trial therapists to experience psilocybin under supportive conditions as part of their training.
“Research suggests there may be substantial benefit for psychedelic therapists to undergo well-supported psychedelic administration as part of their training,” he said.
“For the first time ever, we are able to provide supported psilocybin sessions to our trial therapists to better equip them to accompany participants through profoundly unfamiliar terrain and potentially improve the treatment outcomes.”
New drug application
Incannex has also completed a pre-investigational new drug application meeting with the US Food and Drug Administration (FDA) regarding its clinical development program for the therapeutic strategy.
A package prepared with help from regulatory consultant Camargo Pharmaceutical Services included an overview of the psilocybin-assisted psychotherapy program and specific questions regarding regulatory requirements for opening an investigational new drug folder to conduct human trials in pursuit of US marketing approval.
Incannex said the responses were “positive, constructive and supportive” while the FDA confirmed the planned development pathway to be appropriate.
Specific FDA feedback on the proposed design of the clinical trial will shape a pivotal phase 2b clinical trial, which will be the opening study for the IND application planned for 2022.
Uncontrollable disorder
Generalised anxiety disorder has been described as diffuse, excessive, uncontrollable anxiety which is not restricted to any specific environmental circumstances and occurs almost daily for at least six months.
About 3% of US and Australian adults are estimated to have the disorder in any 12-month period.
This equates to an estimated 9 million patients in the US (with 7 million being diagnosed as moderate-to-severe) and approximately 1 million in Australia.
First-line treatment options include cognitive behavioural therapy, anti-depressants and pregabalin, with benzodiazepines as a second-line, short-term option.
Existing treatments show limited efficacy, with less than 50% of patients achieving remission alongside high relapse rates.
Incannex said the treatment limitations highlight a significant unmet need in the patient group.