A modern twist on a decades-old therapy technique

Incannex Executes License Agreement with Monash University to Develop a Combination Treatment Using Virtual Reality and Psychedelics

Exposure therapy has been a common treatment for anxiety disorders (especially OCD) since the 70’s. It involves gradually exposing patients to triggering situations in a safe environment so they can work through their irrational response.

Now imagine being exposed to your triggers through immersive virtual reality… while on psychedelics.

It may sound scary, but psychedelics could actually provide feelings of safety and allow patients to change their perspective and response to the stimuli.

This is how Incannex Healthcare (IXL) plans to treat patients with severe anxiety disorders in upcoming trials in collaboration with Monash University.

The Australian company debuted on the Nasdaq this week under the symbol ‘IXHL’.


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Incannex executes license agreement with Monash University to develop a combination treatment using virtual reality and psychedelics

Incannex executes license agreement with Monash University to develop a combination treatment using virtual reality and psychedelics

MELBOURNE, Australia, March 3, 2022 /PRNewswire/ — Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing unique medicinal cannabis pharmaceutical products and psychedelic medicine therapies for unmet medical needs, today announced it has executed a license agreement with Monash University (‘Monash University’ or ‘Monash’) to develop a novel treatment that combines Virtual Reality (‘VR’) and psychedelics. This marks the initiation of a second clinical psychedelic therapy program.

Incannex has executed an exclusive, global license in perpetuity over an immersive therapeutic VR environment that has been developed by BrainPark, a state-of-the-art clinical research platform at Monash University’s Turner Institute for Brain and Mental Health. The license allows Incannex to investigate the use of the VR therapy tool in combination with a psychedelic drug to develop a new treatment for severe forms of one or more anxiety disorders.

The established VR treatment uses an exposure-based approach, providing triggering stimuli in a graded and controlled manner (Exposure and Response Prevention or ERP). Alongside specialised clinical support and the administration of a psychedelic drug, this approach may allow for the development of new skills, changes in mental and biological responses to triggering stimuli, and reductions in pathological symptoms and behaviours.

The associated research and development project will be funded by Incannex and undertaken by Monash, led by Dr Paul Liknaitzky (Head, The Clinical Psychedelic Research Lab, Turner Institute and Department of Psychiatry, Monash) and Professor Murat Yücel (Director, BrainPark, Turner Institute, Monash), in collaboration with Professor Suresh Sundram (Head, Department of Psychiatry, Monash) and Dr Rebecca Segrave (Deputy Director, BrainPark, Monash).

Three license fees are outlined in the agreement and payable upon the decision by Incannex to proceed to subsequent phases of the research program. The parties are working towards a research agreement for the first of these trials, which will assess optimal dose, safety, and tolerability of the combination treatment method. Commercial aspects of the license agreement are detailed in Appendix A.

CEO and Managing Director of Incannex, Mr. Joel Latham, said; “We’re delighted to have commenced this exciting project and to have expanded our partnership with Monash. The combination of psychedelic compounds with an evidence-based VR therapy is a leading edge in the field of mental health treatments. We look forward to providing more detail about the project in due course when clinical trial planning has been finalised.”

About Incannex Healthcare Limited
Incannex is a clinical stage pharmaceutical development company that is developing unique medicinal cannabis pharmaceutical products and psychedelic medicine therapies for the treatment of generalised anxiety disorder (GAD), obstructive sleep apnoea (OSA), traumatic brain injury (TBI)/concussion, lung inflammation (ARDS, COPD, asthma, bronchitis), rheumatoid arthritis and inflammatory bowel disease. U.S. FDA approval and registration, subject to ongoing clinical success, is being pursued for each drug and therapy under development. Each indication represents major global markets and currently have no, or limited, existing registered pharmacotherapy (drug) treatments available to the public. IHL 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.
Website: www.incannex.com.au
Investors: investors@incannex.com.au

Forward-looking statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are made as of the date they were first issued and were based on current expectations and estimates, as well as the beliefs and assumptions of management. The forward-looking statements included in this press release represent Incannex’s views as of the date of this press release. Incannex anticipates that subsequent events and developments may cause its views to change. Incannex undertakes no intention or obligation to update or revise any forward-looking statements, whether as of a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Incannex’s views as of any date after the date of this press release.

Contact Information

Incannex Healthcare Limited
Mr Joel Latham
Managing Director and Chief Executive Officer
+61 409 840 786

US IR Contact
Rx Communications Group
Michael Miller

Appendix A

Licence Fees and Royalties

The grant of the license is conditional on the payment of licence fees and royalties that Incannex will pay to Monash as follows:

  • A$300,000 on execution of the license agreement,
  • A$250,000 on execution of a research agreement between Incannex and Monash concerning a second clinical trial,
  • A$250,000 on execution of a research agreement between Incannex and Monash concerning a third clinical trial, and
  • a royalty of 7.5% of net sales, subject to successful commercialisation of a therapy.

SOURCE Incannex Healthcare Limited

A better way to measure depression

MYND Diagnostics Inc. Announces Participation in Approved Monash University (Australia) Government Funded $3 Million Clinical Trial

Diagnosing and measuring depression is usually very subjective, relying on data from patient questionnaires. This leaves room for bias and makes it difficult to know if a treatment is actually working.

MYND Diagnostics of MYND Life Sciences (MYND) developed a biomarker test that provides objective data to solve this problem. It measures inflammation in the brain, which may be what causes depression.

Seeing evidence of improvement gives patients hope in the treatment process, like showing them the “light at the end of the tunnel” as MYND’s CEO explained on a recent Daily Mushroom Podcast.  

The company announced that Monash University will use the biomarker test in a psilocybin study on treatment-resistant depression, which has received $3M in funding from the Australian government. 


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First-of-its-kind study on severe anxiety

World-first psilocybin clinical trial in the treatment of Generalised Anxiety Disorder receives ethics approval

This Australian university just got the go-ahead to conduct a first-of-its-kind study!

Yesterday, Monash University received ethics approval for a triple-blinded, active-placebo-controlled study that will investigate psilocybin-assisted psychotherapy as a treatment for severe Generalized Anxiety Disorder (GAD).

Researchers are looking to recruit 72 patients for the study, which will be conducted in partnership with Incannex Healthcare Ltd (IHL).

The therapists facilitating the study will have the option to undergo their own psilocybin session to better understand what the patients will experience.

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MYND Diagnostics Inc. Announces Participation in a Monash University (Australia) Proposal for $3 Million Clinical Trial

MYND Diagnostics Inc. Announces Participation in a Monash University (Australia) Proposal for $3 Million Clinical Trial

 Evaluating the efficacy of psilocybin-assisted psychotherapy in treatment resistant depression

VANCOUVER, BCOct. 13, 2021 /CNW/ – MYND Diagnostics Inc., a wholly-owned subsidiary of MYND Life Sciences (CSE: MYND) (OTC: MYNDF) is pleased to announce that the Company’s proprietary biomarker test technology will be a pivotal component of a proposed clinical trial seeking partial funds from a $15 million fund allocated by the Australian government.

The proposed project will directly address the desired outcomes by conducting an adaptive dose finding single phase 2b clinical trial of the efficacy and safety of psilocybin assisted psychotherapy (“PAP”) in the treatment of people diagnosed with treatment resistant depression (“TRD”). MYND Diagnostics’ suite of proprietary biomarkers will be utilized in the trials to assess and then monitor blood indicators of trial subjects’ response, progress, and any relapsing to the psilocybin treatments administered in the trials.

The project team will be led by Professor Paul Fitzgerald, of Monash University with 7 scientific collaborators from Monash University, Deakin University and the University of Sydney.  Dr. Fitzgerald is  Director of the Epworth Centre for Innovation in Mental Health (“ECIMH”) and Professor of Psychiatry at the Epworth Clinic / Epworth Health Care in Camberwell. He is a qualified psychiatrist, has a Masters of Psychological Medicine and research PhD. Professor Fitzgerald has run over 20 clinical trials registered through this scheme over the last two decades.

The proposed study is titled Evaluating the efficacy of psilocybin-assisted psychotherapy in treatment resistant depression and MYND Diagnostics’ will play an integral role in the “evaluate” component. If successful, it will lead, within 12 months of completion, to a multi-site phase 3 adaptive trial to take this treatment through to regulatory approval by the Therapeutic Goods Association (“TGA”), the Australian counterpart to Health Canada and the US Food and Drug Administration.

Major Depressive Disorder (“MDD”) is common and results in the greatest global burden of disease. Although there are established treatments for depression, people frequently do not respond to these treatments. At least 1/3 of patients with depression have an inadequate response to medication, many of whom remain persistently unwell. Psilocybin is a naturally derived psychedelic and is converted in the body to psilocin which is the psychoactive agent. The form and dose of drug and psychotherapeutic approach are all important considerations that will be refined through the trial.

Psilocybin has a number of characteristics which support its potential use in patients with depression. These patients often require a psychotherapeutic approach to treatment but struggle to successfully engage in therapy due to impairments of concentration, mood and motivation. Psilocybin has the potential to immediately boost mood enhancing engagement in therapy in addition to any direct physiological effects produced by the substance

“When Dr. Fitzgerald and I signed off on NDAs and entered into discussion back in May of this year, we were optimistic about the receptiveness for this trial within the Australian government’s regulatory climate”, stated Dr. Lyle Oberg MD, MYND Life Sciences CEO. “Depression, and other neuropsychiatric disorders are a plague on the human population that, unfortunately, know no borders. As such, our proposed solutions will require international collaborations within multiple government regulatory ecosystems. We are impressed with Dr. Fitzgerald’s research and leadership in this space, the team he has assembled, and his eagerness to provide one of the very first opportunities to test our emerging suite of biomarker tests.”


MYND Life Sciences, the parent company of MYND Diagnostics INC., is a medical biotech drug research and development company focused on neuro-pharmaceutical and novel psilocybin drug development, diagnostics and vaccines. The Company is advancing pharmaceuticals through rigorous science and clinical trials, while diligently patenting and safeguarding its intellectual property. For more information and to subscribe to the Company’s mailing list, please visit https://myndsciences.com/contact/

Dr. Lyle Oberg, MD, CEO
Email: ir@myndsciences.com
Web: www.myndsciences.com

Forward-Looking Statements

This news release contains forward-looking statements and information within the meaning of applicable securities legislation. Often, but not always, forward-looking statements and information can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Forward looking statements or information involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of MYND to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements or information contained in this release. 

Risks, uncertainties and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information. The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

None of the securities issued in connection with the Offering will be registered under the United States Securities Act of 1933, as amended (the “1933 Act”), and none of them may be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the 1933 Act. This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of the securities in any state where such offer, solicitation, or sale would be unlawful.

SOURCE Mynd Life Sciences Inc.