• Incannex subsidiary Psychennex prepares investigational new drug application for US FDA
  • Application crucial to moving forward psilocybin assisted psychotherapy (Psi-GAD) trial in US
  • IHL says the IND preparation demonstrates its confidence in use of Psi-GAD therapy
  • IHL’s Clarion Clinics prepares to open to provide psychedelic-psychotherapy sessions for PTSD and TRD in Melbourne, Austraila


Incannex Healthcare subsidiary Psychennex has begun preparing an investigational new drug (IND) application to the US Food and Drug Administration (FDA) for its psilocybin assisted psychotherapy development program (Psi-GAD).

Opening an IND with the FDA is the key regulatory approval required by the company to undertake clinical trials in the world’s biggest healthcare market.

Incannex Healthcare (ASX:IHL) says Psychennex is drafting the IND application in preparation for final clinical trial results from the Psi-GAD clinical trial expected in Q4 2023 or Q1 2024.

IHL says the IND submission will include detailed modules on the safety and efficacy of psilocybin assisted psychotherapy across a range of mental health indications.

It will include comprehensive data on the development, quality, and stability of IHL’s psilocybin drug product and the design of the proposed IND opening study.

IHL says the study will be designed for use in a future new drug application (NDA).

IHL says the FDA review process for an IND application involves evaluation of the modules to ensure that the drug product and proposed clinical trial meet regulatory requirements.

IHL has an established history with FDA. Earlier this week, ILH announced that it received FDA approval of its IND for another drug candidate IHL-42X as is prepares to launch a pivotal phase 2/3 clinical trial in the United States.


Solid start to Phase 2 Psi-GAD trial

In March IHL announced interim analysis for the Phase 2 Psi-GAD clinical trial being conducted at Brain Park, Monash University, in Melbourne led by Research fellow Dr Paul Liknaitsky.

Interim statistical analysis predicted a greater than 85% chance of the trial showing statistically significant benefit for the psilocybin treatment arm versus the placebo arm at the conclusion of the trial period.

An independent Data Safety Monitoring Board (DSMB) confidentially reviewing the data for the first 37 out of  72  trial participants for the ongoing Phase 2 clinical trial and recommended no adjustments to the original study design or sample size.

The trial team and DSMB identified no safety concerns at that time and permitted
the trial to continue as originally designed. IHL said that full results of the Phase 2 Psi-GAD trial will be released in Q4 of 2023 or Q1 of 2024.

CEO and MD Joel Latham says starting an IND preparation demonstrates its confidence in the utility of the Psi-GAD therapy.

“The interim analysis and the progress made by Dr Liknaitsky and his team at Monash  University has empowered us to fast-track various strategic business decisions to hasten the development of the therapy,” he says.

“Our organisation is consistently fortifying its position as a frontrunner within the psychedelic research sector, and we eagerly anticipate the results from our Phase 2 trial upon its completion.”

Dominant position in pharmaceutical cannabis and psychedelic space

IHL is developing proprietary pharmaceutical cannabinoid medicines and psychedelic assisted psychotherapies for the treatment of various conditions including:

  • Obstructive sleep apnoea (OSA)
  • Traumatic brain injury (TBI) and concussion
  • Rheumatoid arthritis
  • Inflammatory bowel disease
  • Anxiety disorders
  • Addiction disorders and pain management

Furthermore, with Australia the first country to legalise use of psychedelic drugs to treat mental illness, IHL through its Clarion Clinics is amongst some of the first movers in the world to provide legal psychedelic psychotherapy programs for patients in need of new safe and effective therapies.

 From July 1 the Therapeutic Goods Administration (TGA) medicines containing the psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) can be prescribed by authorised psychiatrists in Australia for treating depression and PTSD.

IHL established subsidiary Clarion Clinics Group with leading experts in the field, including dedicated psychedelic researcher Dr Paul Liknaitsky who is co-founder, director, chief strategy officer, and chief scientific officer of Clarion Clinics.

The first clinic in Melbourne is forecast to open in September.


Move to the NASDAQ

In July IHL announced plans to redomicile to the US with a newly formed Delaware corporation to become the ultimate parent company of the group.

The company says the move will provide greater access to an international capital markets more understanding of its value proposition with peer comparison companies trading at significantly higher market valuations.

The company places significant importance on the US market, boasting 28 pharmaceutical assets related to cannabinoids and psychedelic drugs in various stages of development.


This article was developed in collaboration with Incannex Healthcare, 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.