Clinical-stage pharmaceutical company,Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL) is preparing an application to gain key regulatory approval to begin clinical trials in the US for its psilocybin-assisted psychotherapy development program (Psi-GAD).
Incannex subsidiary Psychennex Pty Ltd has begun preparing an investigational new drug (IND) application to the US Food and Drug Administration (FDA) for Psi-GAD. Opening an IND with the FDA is the key regulatory approval required to undertake clinical trials in the US.
About PsiGAD
PsiGAD is a unique and proprietary form of therapy to treat patients with generalised anxiety disorder (GAD).
Interim analysis for the Phase 2 Psi-GAD clinical trial in March at Monash University predicted a greater than 85% chance of the trial showing statistically significant benefit for the psilocybin treatment arm versus the placebo arm.
Work on the draft IND application comes ahead of final results from the Psi-GAD clinical trial, which are 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. It will also include the design of the proposed IND opening study, which will be designed for use in a new drug application (NDA).
"Confidence in utility"
Incannex CEO and managing director Joel Latham said, “Commencing IND preparation demonstrates our 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.
"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.”