Incannex Healthcare to prepare FDA application for psilocybin-assisted psychotherapy program
Incannex Healthcare (ASX: IHL) subsidiary Psychennex Pty Ltd has started preparing an investigational new drug (IND) application to the US Food and Drug Administration (FDA) for a psilocybin-assisted psychotherapy development program (Psi-GAD).
The submission will include five detailed modules on the safety and efficacy of psilocybin-assisted psychotherapy across a range of mental health indications.
The FDA’s review process involves the evaluation of the modules to ensure that the drug product and proposed clinical trial meet regulatory requirements.
Psychennex will also include comprehensive data on the development, quality and stability of Incannex’s psilocybin drug product and the design of a proposed IND opening study.
Interim analysis
In March, Incannex announced an interim analysis for a Phase 2 Psi-GAD clinical trial being conducted at the Brain Park clinical psychedelic lab within Melbourne’s Monash University.
Interim data 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 was appointed to review data from the first 37 out of a total 72 participants in the trial and recommended no adjustments to the original study design or sample size.
The trial and monitoring board teams identified no safety concerns at the time and allowed the trial to continue as designed.
Final results from the Psi-GAD clinical trial are expected by early next year.
Key regulatory approval
Incannex managing director Joel Latham welcomed the IND process for Psi-GAD as a key regulatory approval needed to undertake clinical trials in the US.
“Commencing IND preparations demonstrates our confidence in the utility of the Psi-GAD therapy,” he said.
“The interim analysis and the progress made by Dr Liknaitzky and his team at Monash University has empowered us to fast-track various strategic business decisions to hasten the development of the therapy.”
Mr Latham said Incannex was “consistently fortifying” its position as a frontrunner within the psychedelic research sector.