Clarion Clinics Receives Ethics Board Endorsement for the First Dedicated Psychedelic-Assisted Therapy Clinic in Australia

Rhea-AI Summary

Incannex Healthcare Ltd (Nasdaq: IXHL) has received Human Research Ethics Committee (HREC) endorsement for administration of psychedelic-assisted therapies for TRD and PTSD. The Melbourne clinic fit-out is complete, and the clinical and administrative teams are in place. The clinic is the first dedicated Psychedelic-assisted therapy clinic in Australia and has received a substantial number of expressions of interest in treatment submissions from potential patients since opening its application process earlier this year.

Positive

• HREC endorsement for administration of psychedelic-assisted therapies is a significant milestone for Incannex Healthcare Ltd.
• The clinic is well-positioned to take advantage of the increasing interest in treatments for TRD and PTSD.
• The company's expertise in psychedelic-assisted therapy has the potential to help hundreds of thousands of people in Australia and tens of millions globally.

Negative

• None.

Insights

Medical Research Analyst

The endorsement by the Human Research Ethics Committee (HREC) for Clarion Clinics to administer psychedelic-assisted therapies represents a pivotal development in the field of mental health treatment. The focus on Treatment Resistant Depression (TRD) and Post-Traumatic Stress Disorder (PTSD) addresses a significant unmet need within the healthcare sector. The potential patient base, estimated at 670,000 individuals in Australia, underscores the substantial market opportunity for Incannex Healthcare Ltd. The transition of psilocybin and MDMA from schedule 9 to schedule 8 by the Australian Therapeutic Goods Administration (TGA) marks a regulatory shift that could catalyze the growth of psychedelic-assisted therapy within the country.

From a medical research perspective, the clinical evidence supporting psychedelic-assisted therapies has been accumulating, with several studies indicating efficacy in populations where conventional treatments have failed. The operational readiness of the Melbourne clinic, with its capacity to treat a significant number of patients annually, positions Incannex to capture early market share. However, the scalability and replicability of their business model in additional locations will be critical to their long-term success.

Financial Analyst

Incannex's announcement may have a notable impact on its financial performance, given the high demand for novel treatments in mental health. The ability to prescribe schedule-8 drugs presents a new revenue stream and a competitive advantage in the Australian market. The company's stock valuation could reflect the anticipated growth from the operational commencement of the Melbourne clinic and the expansion plans both nationally and internationally. Investors will likely monitor the company's ability to scale operations, manage costs and navigate the evolving regulatory landscape. The financial implications hinge on the successful commercialization of the therapies, patient outcomes and the potential for broader legislative changes in favor of psychedelic-assisted therapies.

Industry Analyst

The endorsement of psychedelic-assisted therapies by the HREC and the TGA's reclassification of psilocybin and MDMA for medical use are significant milestones in the pharmaceutical and mental health industries. Incannex's strategic positioning as the first dedicated clinic in Australia for such treatments could serve as a blueprint for other markets. The broader implications for the industry include potential shifts in treatment protocols for TRD and PTSD, increased investment in research and development of psychedelic compounds and heightened interest from the medical community and patients. The long-term impact on the industry will depend on clinical outcomes, patient acceptance and the integration of these therapies into standard healthcare practices.

Highlights:

• Incannex subsidiary, Clarion Clinics, has received Human Research Ethics Committee (HREC) endorsement for administration of psychedelic-assisted therapies for TRD and PTSD.
• HREC approval is required for the administration of psychedelic drugs in Australia.
• Clarion Clinics is the only dedicated psychedelic-assisted therapy clinic in Australia, with intentions to open more clinics across the country and internationally as legislation permits.
• Clarion Clinics team includes pre-eminent psychedelic researchers, psychologists and psychiatrists whose expertise can not easily be replicated in Australia.
• Interest in treatments continues to rise considerably reflecting the high demand for this novel therapy.
• The Melbourne clinic fit-out is complete and the clinical and administrative teams in place.

MELBOURNE, Australia and NEW YORK, Dec. 21, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Ltd (Nasdaq: IXHL) (‘Incannex’ or ‘the Company’) a pharmaceutical company developing proprietary medicinal cannabinoid products and psychedelic assisted psychotherapies for unmet needs is pleased to announce that it has received ethics board endorsement for psychedelic assisted therapy at its first clinic based in Melbourne, Australia, a city of approximately 5.2M people.

In order to prescribe schedule-8 drugs under the Therapeutic Goods Administration (TGA) Authorised Prescriber Scheme, psychiatrists are required to receive HREC endorsement for their qualifications, experience, the qualifications and experience of the treatment team, and the protocols to be used in the treatment of patients with psychedelic compounds. Clarion is pleased to announce that it has received HREC endorsement for both Psilocybin and MDMA assisted therapy for the treatment of Treatment Resistant Depression (TRD) and Post-Traumatic Stress Disorder respectively (PTSD).

The Australian TGA, which is akin to the FDA in the United States, selectively down-scheduled psilocybin for the treatment of TRD and MDMA for the treatment of PTSD from schedule 9 to schedule 8 in July 2023, which allows authorised psychiatrists to prescribe both drugs under the Authorised Prescriber Scheme.

The Melbourne Clarion Clinic will be the first dedicated Psychedelic-assisted therapy clinic in Australia. Located on the Yarra Riverfront in Abbottsford, Melbourne, it has been designed and fitted out specifically to facilitate an optimal environment for psychedelic-assisted therapy. With seven treatments rooms and a group therapy room, the clinic is a commercial scale prototype and has the capacity to treat approximately 600 people per annum in normal working hours and substantially more in extended hour operations. Future clinics are intended to be significantly larger.

Clarion has received a substantial number of expressions of interest in treatment submissions from potential patients since opening its application process earlier this year. It’s estimated that 670,000 people suffer from either TRD, PTSD or both in Australia at any given time and many patients do not respond to traditional treatments for both indications, or experience diminishing efficacy. Psychedelic-assisted therapy has been proved through clinical trials to help a substantial proportion of people who do not respond to traditional treatments.

“This treatment is potentially life-changing for hundreds of thousands of people in Australia and tens of millions globally. Clarion is at the leading edge of mental healthcare, has the right protocols and an experienced team ready to help people through these challenging conditions,” Peter Widdows, IHL Director responsible for Clarion Clinics, said.

“Being the first entrants into this field in Australia will position Incannex, via Clarion, at the forefront of psychedelic-assisted therapies and will facilitate the smooth expansion into more clinics nation-wide as we roll out the treatment protocols and business model. We believe regulations regarding the use of psychedelic-assisted therapies will change in other countries too, following Australia’s lead. Clarion will be well placed to take advantage of this,” Joel Latham, CEO and President of IXHL, said.

This announcement has been approved for release to NASDAQ by the Incannex Board of Directors.

About Incannex Healthcare Inc.

Incannex is a clinical stage pharmaceutical development company that is developing unique medicinal cannabis 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 19 granted patents and 30 pending patent applications. Incannex is listed on the NASDAQ as IXHL

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:

Investor Relations Contact – United States
Alyssa Factor
Edison Group
+1 (860) 573 9637

FAQ

What is the significance of Incannex Healthcare Ltd (Nasdaq: IXHL) receiving HREC endorsement for administration of psychedelic-assisted therapies for TRD and PTSD?

The endorsement is a significant milestone for the company, allowing it to provide treatments for TRD and PTSD at its Melbourne clinic.

What is the location of the first dedicated Psychedelic-assisted therapy clinic in Australia?

The clinic is located on the Yarra Riverfront in Abbottsford, Melbourne, and is designed to facilitate an optimal environment for psychedelic-assisted therapy.

How many people can the Melbourne clinic treat annually?

The clinic has the capacity to treat approximately 600 people per annum in normal working hours and substantially more in extended hour operations.

How many people in Australia suffer from TRD, PTSD, or both?

It's estimated that 670,000 people suffer from either TRD, PTSD, or both in Australia at any given time.

Who is responsible for Clarion Clinics?

Peter Widdows, IHL Director, is responsible for Clarion Clinics.