Clinical stage pharmaceutical development company, Incannex Healthcare Limited (ASX: IHL, announced today:

• the Phase 2a Psi-Generalised Anxiety Disorder clinical trial, led by Dr Paul Liknaitzky at Monash University, has received approval to proceed from the Monash University Human Research Ethics Committee

• the completion of its pre-Investigational New Drug Application (‘pre-IND’) meeting with the US Food and Drug Administration (‘FDA’) regarding the Company’s clinical development program comprising psilocybin-assisted psychotherapy for Generalised Anxiety Disorder (‘GAD’). 

The trial is the first in the world to examine the safety and efficacy of psilocybin for any primary anxiety disorder and is the largest psychedelic trial in Australia to date.

The trial includes a range of treatment innovations alongside the development of a specialised therapist training program. “This is an exciting step for Incannex, the team at Monash, and for the emerging field of psychedelic medicine”, says Dr Liknaitzky.

“Most importantly, this is a solid step in the development of what we hope will be a highly effective treatment for people suffering under the weight of severe anxiety.”

Participant recruitment is expected to commence early in 2022.

Positive pre-IND meeting with FDA

The pre-IND meeting package was prepared with assistance from regulatory consultants Camargo Pharmaceutical Services. Included in the meeting package was an overview of the Psi-GAD program, and specific questions Incannex had on the regulatory requirements for opening an investigational new drug (‘IND’) folder required to conduct human trials in pursuit of FDA marketing approval in the USA. 

Incannex (ASX:IHL) company report release on 30th August. During FY21, Incannex entered regulatory discussions with the FDA regarding drug candidate IHL-675A. IHL Chairman has reported they have established a regulatory pathway to registration, subject to clinical success. IHL (Incannex) will commence clinical trials for IHL-675A in South Australia in 4Q of this year. They will have further discussions with the FDA regarding other drug candidates during the current financial year. Particularly, as they finalise phase 2 studies for IHL-42X in patients with obstructive sleep apnoea and commence phase 2 clinical studies for their psilocybin therapy program.  

Incannex Healthcare Limited (ASX: IHL) have today announced promising signs in their early psilocybin trials for the potential treatment of GAD (Generalised Anxiety Disorder).

Evidence from academic studies has shown that psilocybin-assisted psychotherapy can produce large, rapid and sustained clinical benefits for patients suffering with anxiety and depression symptoms.

Psilocybin-assisted therapy has US FDA ‘Breakthrough Therapy’ designation in the treatment of Major Depressive Disorder and Treatment Resistant Depression. They are developing “Psi-GAD” psilocybin therapy to treat Generalised Anxiety Disorder.

A research proposal for a Phase 2a clinical trial has been submitted to the Human Research Ethics Committee (HREC) in Australia.

A Pre-IND information package and meeting request has also been submitted to US FDA regarding their phase 2b clinical trial. The Clinical trial protocols, including therapy protocols, have been developed by experts in the fields of psychology, psychiatry, and psychedelic medicine.

IHL Quarterly & 4C

Generalised Anxiety Disorder psychotherpy clinical trial protocol completed. Therapist recruitment near completion. Aim is for psilocybin-assisted therapy to gain FDA approval.