Month: May 2023

Incannex Healthcare has announced that three of the world’s top psychedelic therapy and science experts with significant media profiles have joined the advisory board of its subsidiary Clarion Clinics Group.

Medicinal cannabis and psychedelic therapies company Incannex Healthcare (ASX:IHL) has announced three global leaders will join the advisory board of Clarion Clinics Group.

Clarion Clinics is a collaborative venture between IHL and three leading Australian psychedelics experts, Dr Paul Liknaitzky, psychiatrist Professor Suresh Sundram and Sean O’Carroll, who are co-founders, key executives, and directors of the company.

Clarion’s first clinic will open its doors to patients in Q3 CY23 and the company intends to expand rapidly following the successful operation of the first clinic.

Leading researcher and clinician to join board

Joining the board is Dr Bill Richards, who is the Director of Therapy at Sunstone Therapies and a psychologist in the Center for Psychedelic and Consciousness Research at the Johns Hopkins School of Medicine.

Richards is also a consultant/trainer within numerous psychedelic research sites internationally, a teacher in the Program of Psychedelic Therapy and Research at the California Institute of Integral Studies, and a clinician in private practice in Baltimore.

His involvement with psilocybin research started in 1963, and from 1967 to 1977 he pursued psychotherapy research with LSD, DPT, MDA and psilocybin at the Maryland Psychiatric Research Center.

Richards’ research included protocols designed to investigate the promise of psychedelic substances in the treatment of alcoholism, depression, addictions, and the psychological distress associated with terminal cancer, alongside their use in the training of religious and mental-health professionals.

In 1999 at Johns Hopkins, Richards and Roland Griffiths launched the rebirth of psilocybin research after a 22-year period of dormancy in the US.

Media savvy John Hopkins psychiatry professor on board

Professor Matthew Johnson is Professor of Psychiatry and Behavioural Sciences at Johns Hopkins.

He is one of the world’s most published scientists on the human effects of psychedelics and has conducted seminal research in the behavioural economics of drug use, addiction, and risk behaviour.

Working with psychedelics since 2004, he published psychedelic safety guidelines in 2008, helping to resurrect psychedelic research.

As principal investigator, he developed and published the first research on psychedelic treatment of tobacco addiction in 2014.

He is Principal Investigator on funded studies investigating psilocybin in the treatment of opioid dependence and PTSD.

Beyond psilocybin, in 2011 Dr. Johnson published the first-ever blinded human research showing psychoactive effects of salvinorin A, and in 2017 published the first data indicating that MDMA pill testing services may reduce harm.

He has published studies on drugs across nearly all psychoactive classes, including studies    of cocaine, methamphetamine, tobacco/nicotine, alcohol, opioids, cannabis,  benzodiazepines,  psilocybin, dextromethorphan, salvinorin A, GHB, caffeine, and cathinone analogs compounds.

He has received continuous NIH funding as Principal Investigator since 2009, has provided invited presentations in 13 nations, and has been interviewed widely by media about psychedelics and other drugs.

OVID Clinics medical director to join board as well

Medical director of the OVID Clinics in Berlin, along with a co-founder and advisory board member of the MIND Foundation Dr Andrea Jungaberle will also join the Clarion board.

Jungaberle is a clinical specialist in anaesthesia and emergency medicine, a psychedelic therapist, and currently completing a certification in cognitive behavioural psychotherapy.

She is a published author, workshop leader, yoga teacher, and has participated in several   accredited training sessions in psychedelic therapy.

She is part of the EPIsoDE study team, using psilocybin-assisted psychotherapy to treat 144 depressive patients, and is a site principal investigator in Beckley Psytech’s Phase IIa study on 5MeO-DMT in treatment resistant depression.

At OVID Clinics,  Jungaberle has conducted and/or supervised more than 1400 Ketamine applications within a psychedelic-assisted psychotherapy paradigm in over 270 patients.

World watching Clarion Clinics

IHL Director Peter Widdows said he’s delighted and honoured that such esteemed professionals have decided to join the Clarion team.

“It’s a testament to the vision that Paul, Sureshand Sean are bringing together to provide this vital service to many people in great need,” he said.

“As Australia is the first country to legalise the use of psychedelic drugs in the treatment of mental illness, the eyes of the world are upon us, and having people of this calibre and experience onboard will help us ensure we provide world-leading effective treatments in an ethical and safe way.”

Clarion Clinics Group co-founder, director, chief strategy officer, and chief scientific officer Dr Paul Liknaitzky said the new board members are wonderful colleagues and inspiring people.

“Each brings deep experience and hard-won wisdom that will help guide our efforts within the Clarion venture towards supporting our clients to live their best lives,” he said.

“I’m grateful for their trust and support.”

IHL managing director and CEO Joel Latham said the calibre of the new board members shows the importance of the Clarion venture.

“When people with the global reputations of Bill, Matthew and Andrea wish to help shape your venture, you know you’ve hit on something special, something which could help improve the lives of millions of people around the world,” he said.

Clarion Clinics Group recently entered a lease for riverfront premises in Melbourne’s inner north suburb of Abbottsford.

The premises will be used to provide psychedelic-assisted psychotherapy and is expected to be ready before September 2023 to facilitate first patient treatments shortly after this time.

This article was developed in collaboration with Incannex Healthcare, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

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Incannex’s psychedelics focused subsidiary, Psychennex, believes that it has the best team of experts to capture the emerging opportunities in psychedelic-assisted psychotherapy.

Medicinal cannabis and psychedelic therapies company, Incannex Healthcare (ASX:IHL), has provided the market with an update on its subsidiary, Psychennex.

Psychennex is a psychedelic-assisted psychotherapy company that’s  pioneering the Australian psychedelics sector via its clinical research programs and service delivery through its Clarion Clinics Group.

The company holds all of Incannex’s psychedelic assets in one place – which include PsiGAD Clinical Trials, MOVER License, as well as all future psychedelic clinical trials.

Psychennex is expected to open its first Clarion Clinic in Melbourneʼs inner-northern suburb of Abbotsford in Q3 this year.

The model clinic will serve as a prototype for the companyʼs planned rapid roll-out of further clinics. While being a prototype, the clinic will be run at a commercial scale and is a significant business in its own right.

The opening is part of Incannex’s strategy to become one of the first movers to take advantage of a landmark decision by the Therapeutic Goods Administration (TGA).

Earlier in February, TGA said that from July 1st this year, medicines containing the psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) can be prescribed by authorised psychiatrists in Australia for treating depression and PTSD.

That decision has made Australia the first country in the world to recognise psychedelics as medicines.

More psychedelic clinics planned

Looking ahead, Clarion Clinics  plans to open multiple psychedelic-assisted  psychotherapy clinics in Australia and overseas.

The plan is to serve the Australian market, which is anticipated to be more than $2 billion per annum, with the global market being closer to $60 billion.

The company is ramping up to open up to 10 owned clinics as quickly as possible, due to expected “pent up” demand for such a service amongst patients resistant to existing treatments such as anti-depressants.

The ultimate target is to open 80+ clinics, using a combination of franchised and licensed business models.

At each step, the company will decide whether owning or licensing/franchising the clinics is the better option, based on speed to market, financial returns and management capability.

Incannex also seeks to open in geographies around the world where population is large and  legislation allows.

The decision to open at a particular location will be dictated by the regulatory and competitive environment of target geographies.

A strong team of experts

Psychennex has an exclusive, perpetual, global license over ground-breaking virtual reality technology developed at the BrainPark in Monash University.

This technology will be used in conjunction with psychedelic-assisted psychotherapy by providing triggering stimuli in a controlled manner.

Psychennex is also putting together a strong team of experts, and says that there is no other team with the same academic and hands-on experience in the psychedelics field in Australia.

“There are very few experienced psychedelic-assisted psychotherapists in Australia, and the team we are assembling includes many of the most experienced practitioners in the country,” said Sean O’Carroll, Lead Psychotherapist and Trainer at Monash.

“We take this responsibility seriously, and are uniquely placed to support the emergence of psychedelic-assisted psychotherapy as a safe and efficacious new treatment modality.”

A number of providers, motivated by the TGA ruling, have said they will enter the market for psychedelic- assisted psychotherapy.

While Incannex believes that competition will be good for the industry, the company is confident that its world class team have the edge and experience in this field.

This article was developed in collaboration with Incannex Healthcare, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

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Incannex Healthcare’s subsidiary Clarion Clinics will be the first dedicated psychedelic-assisted psychotherapy business in Australia and is expected to open its doors to patients later this year.

Medicinal cannabis and psychedelic therapies company, Incannex Healthcare (ASX:IHL) has progressed its plans for its psychedelic-assisted psychotherapy business Psychedelic Clinics.

IHL has announced that its subsidiary company, Clarion Clinics Group, has entered a lease for riverfront premises in Melbourne’s inner north suburb of Abbottsford.

The premises will be used to provide psychedelic-assisted psychotherapy and is expected to be ready before September 2023 to facilitate first patient treatments shortly after this time.

Partnerships with clinical professionals

From July 1 this year, medicines containing the psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) can be prescribed by authorised psychiatrists in Australia for treating depression and PTSD.

IHL has been developing commercialisation plans for psychedelic clinics well before a landmark decision by the Therapeutic Goods Administration (TGA) making Australia the first country in the world to recognise psychedelics as medicines.

Psychedelic Clinics have been developed under the leadership of Peter Widdows, a long-standing IHL director.

IHL has also entered partnerships with Australia’s leading clinical psychedelic professionals, who all have extensive experience within clinical psychedelic research, treatment, and training.

Commercial scale prototype

The clinic is designed as a commercial scale prototype, which can be scaled up and replicated to other locations.

It will have capacity to treat more than 600 patients annually during normal working hours and substantially more in extended hour operations.

IHL has ordered an initial supply of psilocybin and MDMA, through an arrangement with PharmalaBiotech, to facilitate the commencement of clinical operations.

Pioneering venture

 Clarion Clinics Group plans to open multiple psychedelic-assisted  psychotherapy clinics in Australia and overseas.

“The initial clinic is a pioneering venture that will implement best practice in psychedelic treatment and aims to positively impact the lives of many people suffering with intractable mental health conditions,” Widdows said.

“It alone is a substantial business opportunity and has the potential to expand into a very sizable venture with the subsequent planned roll-out of numerous clinics.”

Widdows said the estimated Australian market for psychedelic-assisted psychotherapy is anticipated to be more than $2 billion per annum and the global market closer to $60 billion.

“Clarion Clinics Group is uniquely placed to be a significant player in this market by entering early, having the treatment model, business model and the best qualified people in place.” Key people include highly-respected psychiatrist Professor Suresh Sundram, and Dr Paul Liknaitzky, a neuroscientist and psychedelics clinical trial researcher.

IHL CEO and managing director Joel Latham said Clarion Clinics will be the first dedicated psychedelic-assisted psychotherapy business in Australia.

“We’re delighted to be at the forefront of an industry that has the potential to change the lives of thousands of people who have been living with conditions for which there have been no adequate treatment options,” he said.

This article was developed in collaboration with Incannex Healthcare, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

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Results from a Phase-1 clinical of Incannex’s anti-inflammatory drug IHL-675A in healthy volunteers adds to the company’s confidence in proceeding with assessment in patients with inflammatory diseases.

Medicinal cannabis and psychedelic therapies company, Incannex Healthcare (ASX: IHL) has announced promising final results from the Phase-1 clinical trial undertaken to assess pharmacokinetics and safety of the anti-inflammatory drug IHL-675A.

IHL-675A is a combination cannabinoid drug comprising cannabidiol (CBD) and hydroxychloroquine (HCQ) in a fixed dose combination.

IHL-675A was observed to outperform either CBD and HCQ in various pre-clinical models of inflammation, including in vivo models of rheumatoid arthritis, inflammatory bowel disease and lung inflammation.

Synergistic anti-inflammatory activity of CBD and HCQ was observed in these distinct pre-clinical studies and was evidence to support the company’s international patent application over the drug.

The Phase-1 trial measured the safety, tolerability, and pharmacokinetic profiles of IHL-675A compared to reference listed drugs, Epidiolex (CBD) and Plaquenil (HCQ).

Three cohorts of 12 participants – 36 in total – received either IHL-675A, CBD or HCQ and the clinical assessments were identical across the three arms of the trial.

Participants were monitored for adverse events and had blood samples collected for
pharmacokinetic (PK) analysis over a four-week period.

PK analysis determines the absorption, distribution, metabolism, and excretion (also known as ADME) of drugs in the body.

The trial was conducted by CMAX Clinical Research in Adelaide and managed by Avance Clinical.

Safety and tolerability results

IHL-675A was well tolerated, with no adverse events of concern and no serious adverse events reported.

The same number of treatment-related Treatment Emergent Adverse Events (TEAEs) were reported for IHL-675A as for Epidiolex.

TEAEs included abdominal pain, dizziness, fatigue, frequent bowel movements, headache, and somnolence.

All TEAEs were minor except one incidence of moderate severity abdominal cramps which resolved soon after onset.

Both active pharmaceutical ingredients, CBD and HCQ, are absorbed from IHL-675A.

Trends in PK profiles indicate that the uptake of CBD may be more rapid for IHL-675A than Epidiolex and uptake of HCQ may be slower for IHL-675A than Plaquenil.

This could be advantageous for IHL-675A. CBD provides immediate relief for inflammation and pain whereas HCQ is a slower acting molecule and provides extended relief.

Crucial step to move forward

The safety and pharmacokinetic data from the Phase-1 clinical trial in healthy volunteers adds to the company’s confidence in proceeding with assessment of IHL-675A in patients with inflammatory diseases.

IHL chief scientific officer Dr Mark Bleackley said results from the Phase-1 trial are a critical milestone in the development of IHL-675A.

“Data on the safety and pharmacokinetics of the drug combination are essential for supporting to administration of the drug to rheumatoid arthritis patients on a daily basis over an extended period in the Phase-2 trial,” he said.

“We are excited to better understand the therapeutic potential of IHL-675A as the development pipeline continues to progress.”

Next Steps – Phase-2 Trial in rheumatoid arthritis patients

IHL said as HCQ is already approved for treatment of rheumatoid arthritis, it is the first indication for which IHL-675A will be assessed in a Phase-2 clinical trial.

The trial will include 120 participants who meet the eligibility criteria, and participants will be randomised to one of four arms – either IHL-675A, CBD alone, HCQ alone or placebo.

The primary endpoint for the study is pain and function relative to baseline
determined via the score on the RAPID3 assessment at 24 weeks. 

Plans for Phase-2 trial in other inflammatory diseases

Trial designs for Phase-2 studies in patients with inflammatory bowel disease and lung inflammation are also being developed.

The treatment of these three indications has a combined global annual market
size of exceeding US$125 billion annually.

IHL has filed a request for pre-IND meeting on the development of IHL-675A for treatment of arthritis with the US Food and Drug Administration (FDA).

Following the pre-IND meeting, IHL intends to open an IND in parallel with the Australian Phase-2 study.

This will enable trials in the US if the Australian study continues to support the therapeutic potential of IHL-675A in patients with arthritis.

Positive in-vivo results

In March of 2021, IHL announced results from an in vivo model of rheumatoid arthritis where IHL-675A was observed to benefit the treatment of rheumatoid arthritis in mice greater than that of CBD or HCQ alone.

HCQ, is widely used for treatment of rheumatoid arthritis in the form of hydroxychloroquine sulphate, marketed as Plaquenil.

An improvement to patient wellbeing achieved by IHL-675A would potentially open a major economic opportunity for IHL arthritis.

IHL CEO and managing director Joel Latham said a large sub-group of people with rheumatoid arthritis are using hydroxychloroquine or cannabidiol to help to alleviate their symptoms.

“We are delighted with the safety data and with the unique pharmacokinetic characteristics of IHL-675A that may be beneficial for patients with rheumatoid arthritis,” he said.

“By undertaking pivotal clinical studies over IHL-675A, we intend to disrupt the markets for both CBD and hydroxychloroquine as they currently pertain to the treatment of rheumatoid arthritis.”

This article was developed in collaboration with Incannex Healthcare, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

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