- Incannex Healthcare (IHL) partners with Monash University to study a treatment for Generalised Anxiety Disorder (GAD)
- The parties have submitted a proposal to the Human Research Ethics Committee outlining a phase 2a clinical study of “Psi-GAD” planned this year
- If approved, the study at Monash’s BrainPark research clinic will combine the drug psilocybin with specialised therapy to treat patients with the condition
- Simultaneously, IHL has requested a pre-investigational new drug meeting with the FDA to discuss a follow-up phase 2b pivotal clinical trial for 2022
- Shares in Incannex Healthcare are trading in the grey at 26.5 cents at 10:22 am AEST
Clinical-stage pharmaceutical developer Incannex Healthcare (IHL) has partnered with Monash University to study a treatment for Generalised Anxiety Disorder (GAD).
Together the parties have submitted a research proposal to the Human Research Ethics Committee outlining a phase 2a clinical study of “Psi-GAD”.
Phase 2a clinical trial
If approved, the trial will combine the administration of a drug called psilocybin with specialised therapy to treat patients with the condition.
This research will be conducted at Monash’s state-of-the-art neuroscience clinic, Brain Park, at the Turner Institute for Brain and Mental Health.
Under a randomised, triple-blind, active-placebo-controlled trial, 72 participants will experience two psilocybin or active-placebo dosing sessions and up to 11 non-drug, specialist psychotherapy sessions over a period of 10 weeks.
Primary outcomes will include the safety, efficacy and tolerability of the treatment, with secondary outcomes including quality of life and functional impairment.
Phase 2b clinical trial
Simultaneously, the company has requested a pre-investigational new drug (IND) meeting with the US Food and Drug Administration (FDA), which is intended to provide clarity around a follow-up phase 2b pivotal clinical trial.
Incannex intends to leverage guidance from this meeting, together with data and learnings from the initial trial, to prepare an IND application for the FDA targeted in 2022.
Monash University Research Fellow and Chief Principal Investigator Paul Liknaitzky commented on the prospective studies.
“Over the past few months, the Clinical Psychedelic Research Lab at Monash has made substantial progress on the Psi-GAD program, developing trial protocols, treatment protocols, a therapist training program, site infrastructure, risk mitigation planning, recruiting therapists and a suite of scientific innovations,” Dr Liknaitzky said. “All (are) part of a solid foundation for rigorous, innovative and patient-focussed research.”
“This world-first and ambitious clinical research program is rapidly developing, supported by a strong partnership between Monash and IHL.”
The phase 2a trial is anticipated to begin in 2021 with phase 2b to follow next year.
According to IHL, an estimated seven million people in the US alone have moderate to severe Generalised Anxiety Disorder and experience intense, persistent and often debilitating anxiety symptoms.
Shares in Incannex Healthcare are trading in the grey at 26.5 cents at 10:22 am AEST.