Incannex to prepare FDA IND application for psi-GAD

Incannex Healthcare announces 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. CEO and Managing Director of Incannex, Mr 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.”