Incannex Healthcare (ASX: IHL) has reported interim data from its Phase 2 clinical trials to treat anxiety through the use of psychedelics. Upon completion of the trials, the Company will seek to progress this new therapy and offer renewed hope for individuals seeking non-pharmacological solutions to treat mental health.
Psilocybin-assisted psychotherapy has emerged as the new promising treatment for mental health conditions. Developed in partnership with Dr Paul Liknaitzky from Monash University’s Clinical Psychedelics Lab, the 10-week trial namely called PsiGAD1 will assess its safety, efficacy via an innovative psilocybin dosing program – delivered in two separate sessions using either psilocybin or an active placebo – to evaluate aspects such as safety, efficiency, Quality of Life (QOL) along with mental and physical health.
Incannex Chief Scientific Officer, Dr Mark Bleackley, said: “Monash University is a major globally recognised and highly innovative university. Dr Liknaitzky and his team are at the forefront of psychedelic research and development.”
To date, 45 participants have been enrolled in the trial, with 29 surpassing completion of the treatment protocol and outcome assessment. An independent Data Safety Monitoring Board (DSMB), composed of external experts unassociated with the study, has kicked off their interim analysis of data collected thus far – a crucial process that ensures fair evaluation of data while maintaining a blinded environment with integrity to obtain accurate results. Due by March 2023, the third-party body will issue their recommendations to Incannex which it will be provided to the public via another press release.
“The PsiGAD1 trial is supported by a fantastic team of researchers and clinicians and has been an intensive and gratifying project to lead”, said Dr Paul Liknaitzky, Principal Investigator on the trial. “I look forward to the recommendations of the Data Safety Monitoring Board and to continuing to progress this trial to completion.”
In the light of medical advances, there is a great potential in psychedelic medicines and medicinal cannabinoids to treat many illnesses and conditions. The interim results of Incannex Healthcare’s research into these medicines have been promising so far, where moving forward, the company will be continuing its Phase 2 trials as they attempt to bring their proprietary cannabinoid products and psychedelic therapies to market.
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