Incannex Completes Dosing in Psilocybin Anxiety Study
Incannex Healthcare (Nasdaq: IXHL) has completed dosing of 72 participants in a Phase 2 clinical study evaluating a psilocybin treatment program for patients with generalized anxiety disorder (GAD). Incannex is preparing an Investigational New Drug (IND) application and will submit to the FDA following receipt of topline results from this clinical trial.
Joel Latham, Chief Executive Officer and Director of Incannex, said, “We’re delighted to have completed all PsiGAD-1 treatments for our trial participants as we work towards finalizing an FDA IND application to advance the development of this important treatment modality. Generalized anxiety disorder is characterized 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.”
Highlights
Incannex’s study is a randomized 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.
The study also assessed safety, as well as other secondary objectives of efficacy and quality of life.
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.
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.
Incannex has a strong patent filing strategy in place as it develops its products and therapies in conjunction with its medical and scientific advisory board and partners. The Company holds 20 granted patents and over 30 pending patent applications.
