Incannex to Prepare FDA IND Application for Psilocybin-assisted Psychedelic Psychotherapy Program, Known as Psi-GAD

MELBOURNE, Australia, Aug. 24, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that its subsidiary Psychennex Pty Ltd has commenced preparations of an investigational new drug (‘IND’) application to the U.S. Food and Drug Administration (‘FDA’) for the Company’s 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 United States. The Company has commenced the process of drafting the IND application in preparation for the receipt of final clinical trial results from the Psi-GAD clinical trial expected in Q4 2023 or Q1 2024.

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 Incannex’s psilocybin drug product and the design of the proposed IND opening study, which will be designed in a manner suitable for use in a new drug application (NDA).

The modules of the IND are:

• Module 1 – Administrative Information and Prescribing Information
• Module 2 – Nonclinical/Clinical Overviews and Summaries
• Module 3 – Quality data
• Module 4 – Nonclinical Study Reports and Key Literature References
• Module 5 – Clinical Study Reports, Clinical Protocol and Investigator Information
  

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.

The Company announced on 15 March 2023 interim analysis for the Phase 2 Psi-GAD clinical trial being conducted at Brain Park, Monash University. Interim statistical analysis predicted that there was a greater than 85% chance of the trial showing statically 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’) was tasked with 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.