Incannex Completes Dosing and Therapy in Phase 2 “PsiGAD” Clinical Trial Assessing Psilocybin-assisted Psychotherapy for Generalized Anxiety Disorder; Data Analysis Commences - Seite 2

FDA IND Application Preparations for PsiGAD

Incannex commenced the process of drafting an FDA IND application in August 2023 in preparation of the receipt of topline results from the PsiGAD-1 clinical trial, and submission soon thereafter.

In March of 2023, Incannex announced the interim analysis for the Phase 2 PsiGAD-1 clinical trial, which predicted a greater than 85% chance that the trial would show 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. At that time, the DSMB recommended no adjustments to the original study design or sample size and acknowledged no safety concerns in the operation of the trial.

Documentary on the Monash Clinical Psychedelic Lab to be released in Late February 2024

Commissioned by the Australian Special Broadcasting Service (SBS), a film production company has tracked the activities of the Monash Clinical Psychedelic Lab for over 2 years, producing a documentary that focuses on the PsiGAD research program. Psychedelics: Stepping into the Unknown is a feature documentary on the first psychedelic lab in Australia and key partner in Incannex’s psychedelic research program. The documentary is currently scheduled for release on the SBS streaming service in late February 2024, and aims to contribute to the awareness of mental health, psychedelic therapies, and the expertise required for safe delivery.

About Incannex Healthcare Inc.

Incannex is a clinical stage pharmaceutical development company that is developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for the treatment of obstructive sleep apnoea (OSA), traumatic brain injury (TBI) and concussion, lung inflammation (ARDS, COPD, asthma, bronchitis), rheumatoid arthritis, inflammatory bowel disease, anxiety disorders, addiction disorders, and pain, among other indications.

U.S. FDA approval and registration, subject to ongoing clinical success, is being pursued for each drug and therapy under development. Each indication under investigation currently has no, or limited, existing registered pharmacotherapy (drug) treatments available to the public and represent major global economic opportunities to Incannex and its shareholders.