Incannex Completes Dosing and Therapy in Phase 2 “PsiGAD” Clinical Trial Assessing Psilocybin-assisted Psychotherapy for Generalized Anxiety Disorder; Data Analysis Commences
Incannex Healthcare Inc. completed dosing and treatment protocols for all 72 participants in the PsiGAD-1 clinical trial evaluating its psilocybin treatment program for patients with generalized anxiety disorder. The company anticipates topline results within Q1 2024 and is well-advanced in the FDA IND application process. An independent documentary covering Monash Clinical Psychedelic Lab and PsiGAD research program will be released by SBS television network in late February 2024.
The completion of the PsiGAD-1 clinical trial by Incannex Healthcare Inc. represents a significant milestone in the development of alternative therapies for generalized anxiety disorder (GAD). The trial's design—a randomized, triple-blind, active-placebo-controlled Phase 2 study—adheres to rigorous scientific standards, which bolsters the credibility of the results. The use of the Hamilton Anxiety Rating Scale (HAM-A) as a primary measure is a well-established method in clinical research for quantifying anxiety levels and therefore, provides a reliable metric for assessing the efficacy of the psilocybin treatment.
With the interim analysis indicating a greater than 85% chance of statistically significant benefit of the treatment arm over the placebo, the potential for psilocybin-assisted psychotherapy to emerge as a viable treatment for GAD is noteworthy. This is particularly relevant considering the current limitations and side effects associated with conventional GAD medications. However, it is crucial to await the topline results to fully understand the safety, tolerability and quality of life outcomes before drawing definitive conclusions.
From a financial perspective, Incannex's progress in the PsiGAD-1 trial and the advancement of the FDA IND application are likely to be closely monitored by investors. The company's stock could see increased volatility around the announcement of the topline results. Positive outcomes could potentially lead to a surge in investor confidence, reflecting the high unmet need for innovative treatments in the mental health market. Conversely, any setbacks or unfavorable data could adversely affect the company's valuation.
Investors should also consider the broader implications of the trial's success. Approval of the treatment by regulatory bodies such as the FDA could open up a new market segment for Incannex and position it as a leader in psychedelic medicine therapies. The potential revenue streams from such an innovative treatment could be substantial, given the prevalence of GAD and the demand for more effective therapies.
The documentary 'Psychedelics: Stepping into the Unknown,' focusing on the Monash Clinical Psychedelic Lab and Incannex's research program, is an example of increasing public interest in psychedelic therapies. This surge in awareness could contribute to a more favorable market environment for companies like Incannex. The societal shift towards accepting and understanding the potential benefits of psychedelics in mental health treatment could facilitate a smoother path to market adoption, provided the clinical data supports safety and efficacy.
Long-term market dynamics will likely be influenced by the outcomes of clinical trials like PsiGAD-1, regulatory decisions and the evolving public perception of psychedelic therapy. Companies that are at the forefront of such research may benefit from first-mover advantages, including establishing key partnerships, securing intellectual property rights and shaping the regulatory framework.
01/18/2024 - 08:22 AM
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.”
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.
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.
Website: www.incannex.com Investors: investors@incannex.com.au
Forward-looking statements
Contact Information:
Incannex Healthcare Inc. admin@incannex.com.au
Investor Relations Contact – United States jdrew-bear@edisongroup.com
The PsiGAD-1 clinical trial is evaluating Incannex's psilocybin treatment program for patients with generalized anxiety disorder.
The topline results from the PsiGAD-1 clinical trial are anticipated within Q1 2024.
The FDA IND application process is well-advanced after commencing preparations in August 2023.
The documentary is scheduled for release on the SBS streaming service in late February 2024.
