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

Highlights:

• 72 patients treated at purpose-built facilities within Monash University, Melbourne, Australia.
• Topline results from the trial anticipated within current Q1 2024.
• FDA IND application is well-advanced after commencing preparations in August, 2023.
• Independent documentary covering Monash Clinical Psychedelic Lab and PsiGAD research program to be released by SBS television network following 2 years of filming and production.

MELBOURNE, Australia and NEW YORK, Jan. 18, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (‘Incannex’ or the ‘Company’), a pharmaceutical company developing unique medicinal cannabinoid pharmacotherapies and psychedelic medicine therapies is pleased to announce that it has completed dosing and treatment protocols for all 72 participants in the PsiGAD-1 clinical trial, the Company’s Phase 2 study evaluating its own psilocybin treatment program for patients with generalized anxiety disorder (GAD).

PsiGAD-1 is a randomised triple-blind active-placebo-controlled Phase 2 trial. The primary objective of the study is to determine whether a 7-week program of psilocybin-assisted psychotherapy for GAD is superior to active placebo-assisted psychotherapy in decreasing symptoms of GAD, as measured by the change in the Hamilton Anxiety Rating Scale (HAM-A) from baseline to week 11. Safety and tolerability were assessed, as well as other secondary objectives of efficacy and quality of life.

“We’re delighted to have completed all PsiGAD-1 treatments for our trial participants as we work towards finalising an FDA IND application to advance the development of this important treatment modality,” said Joel Latham, Chief Executive Officer and Director of Incannex. “Generalised anxiety disorder is characterised by persistent, debilitating and excessive worry, affects millions of people globally, and has inadequate existing treatment options. We’re thankful to our research partners at Monash University who conducted a thorough and extensive clinical trial, screening 975 people and undertaking 174 psychedelic dosing sessions in one of the largest clinical trials of its kind.”