- Incannex Healthcare (IHL) and Monash University will push ahead with plans to run a world-first clinical trial for generalised anxiety disorder (GAD)
- The phase two trial will be led by Dr Paul Liknaitzky and test the effects of psilocybin-assisted psychotherapy on GAD
- Around 72 patients will be recruited for the trial, which will be conducted at Monash’s BrainPark facility in Victoria
- Incannex will consult with the U.S. Food and Drug Administration (FDA) to discuss clinical trial protocols as it wants the trial to be FDA compliant
- IHL also stated that once the trial is up and running, it will be the largest psychedelic research and development program in Australia
- Shares in Incannex Healthcare have opened up 13.8 per cent to trade at 16.5 cents each
Incannex Healthcare (IHL) and Monash University will push ahead with plans to run a world-first clinical trial for generalised anxiety disorder (GAD).
IHL advises it has formally executed a partnership agreement with Monash to conduct the psilocybin-assisted psychotherapy trial to treat GAD.
The phase two trial will be led by Dr Paul Liknaitzky and conducted at the university’s BrainPark platform within its Turner Institute for Brain and Mental Health in Victoria.
Around 72 patients will need to be recruited as part of the trial, with treatment to include psilocybin dosing sessions alongside a program of specialised psychotherapy.
The belief is that psilocybin — a psychoactive molecule which occurs naturally in some mushrooms and modulates mood — can be a “safe and highly effective” mental health treatment when combined with psychotherapy.
Once the trial is up and running, Incannex said this new study will be the largest psychedelic research and development program in Australia.
“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,” Trial Lead Paul Liknaitzky said.
“I’m confident that we will conduct a highly rigorous, patientfocused, world-class trial to assess the safety and efficacy of this treatment approach for people dealing with severe anxiety,” he added.
Next steps for IHL include consulting with the U.S. Food and Drug Administration (FDA) to discuss clinical trial protocols.
The company wants to ensure the trial is FDA compliant, to keep up with other research programs testing the drug on depression which have received Breakthrough Designation from the drug body.
Shares in IHL have opened strong, up 13.8 per cent to trade at 16.5 cents each at 10:45 am AEDT.