The world-first treatment is on track to commence clinical trials in early 2022.

Across its extensive product suite, clinical stage pharmaceutical development company Incannex Healthcare (IHL:ASX) is developing a unique psilocybin therapy for the treatment of generalised anxiety disorder (GAD).

And the company announced two more key updates that further solidified its development pathway this morning, ahead of clinical trials scheduled to start early next year.


Ethics approval

The Phase 2a trial for IHL’s Psi-GAD treatment is being led by Dr Paul Liknaitzky, Head of Clinical Psychedelic Research at Monash University and also a member of IHL’s scientific advisory board.

On a global level, it will mark the first clinical trial examining the safety and effectiveness of psilocybin in the treatment of GAD. It’s also the largest psychedelic trial in Australia to-date.

On that front, IHL took a critical step forward this morning with confirmation the trial had received approval to proceed from the Monash University Human Research Ethics Committee (MUHREC).

The project also achieved another world-first; approval for trial therapists to take psilocybin under supportive conditions as part of their training.

The move is based on research which suggests there may be “substantial benefits” to the trial process where therapists have experience with the treatment, Liknaitzky said.

With approval now achieved, the research team will commence the drug importation process and complete the training program for therapists, before patient recruitment kicks off in early 2022.


Pre-IND meeting with the FDA

Along with ethics approval for the trial, IHL also received positive feedback from US health regulators following the submission of its pre-investigational new drug (pre-IND) application.

In response, the FDA “confirmed that the therapeutic strategy for the development of a psilocybin-assisted therapy for GAD is appropriate, and conveyed interest in its development”.

The FDA also provided guidance on what will be required in a long-term drug development strategy, with the goal of achieving full approval and marketing authorisation.

As part of the feedback response, crucial information was provided which will inform how IHL constructs the parameters of its Phase 2b trial, following either interim or full results from the Phase 2a trial.

The successful application IHL submitted included an overview of the Psi-GAD program, and answers to specific questions as part of an “investigational new drug (‘IND’) folder required to conduct human trials, in pursuit of FDA marketing approval in the USA”, the company said.

As it moves towards the clinical trial process, momentum is building for IHL’s world-first treatment which is also has a major market opportunity.

The project is comparable to projects such as those run by MindMed Inc and Compass Pathways, both of which are listed on the Nasdaq. Incannex is also pursuing its own Nasdaq listing after recently submitting its registration document with the US financial regulator.

Research indicates that around 3% of adults in the US and Australia suffer from GAD in any 12-month period.

That equates to an addressable market of around 9m people in the US, around 1m people in Australia.

This article was developed in collaboration with Incannex, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.