Incannex submits HREC proposal and FDA pre-IND meeting request for Psi-GAD psilocybin therapy for Generalised Anxiety Disorder

We wish to draw your attention to an announcement and presentation released by Incannex (ASX:IHL) this week. The company has completed a Human Research Ethics Committee (HREC) submission for a phase 2a trail on patients with Generalised Anxiety Disorder (GAD) using psilocybin combined with specialised therapy in the form of psychotherapy sessions by trained professionals over a period of 10 weeks. In addition to this Incannex has submitted a comprehensive information package to the US Food and Drug Administration (FDA) for the purpose of requesting a pre-IND (Investigational New Drug) meeting.

These two submissions follow extensive and collaborative work led by Principal Investigator Dr Paul Liknaitzky (Head, Clinical Psychedelic Research Lab, Monash University) along with Co-Investigators Professor Suresh Sundram (Head, Dept of Psychiatry, Monash University) and Professor Murat Yucel (Director, BrainPark, Monash University). The wider research team includes Australian and international experts in psychedelic-assisted therapies, psychometric evaluation, qualitative research and therapist training. The Phase 2a trial will be the first of its type in the world and will be conducted at BrainPark, a state-of-the-art neuroscience facility located at Monash University’s Turner Institute for Brain and Mental Health. Primary outcomes from the phase 2a trial will be safety efficacy and tolerability with secondary outcomes being quality of life, functional impairment and comorbidities.

Generalised Anxiety Disorder is characterised by diffuse, excessive, uncontrollable anxiety that is not restricted to any specific environmental circumstances, and occurs more days than not for at least 6 months. About 3% of the adult population in the USA and Australia are estimated to have GAD in any 12 month period which equates to 9 million people in the US and 1 million here. There are limited treatments available which highlights a significant unmet need for this patient group.


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