Author: incannex@admin

Incannex has been given the green light to start its Phase 2 clinical trial to assess the safety and efficacy of IHL-675A, a combination drug that combines a specific proprietary formulation of CBD and another long standing prescription drug for rheumatoid arthritis.

Biotech Incannex Healthcare (ASX:IHL)  has received approval from Bellberry Human Research Ethics Committee (HREC) for the lead site Emeritus Research in Melbourne for its Phase 2 clinical trial.

The Phase 2 trial follows the successful Phase 1 clinical trial whereby both active  pharmaceutical  ingredients,  cannabidiol  (CBD)  and  hydroxychloroquine sulphate (HCQ) were absorbed from IHL’s fixed dose combination product IHL-675A.The drug product was also observed to be well tolerated, with no adverse events of concern.

Before starting  clinical  trials, IHL  observed  positive  results  from  an  animal model  of  rheumatoid arthritis.

IHL-675A was observed to be more effective at reducing rheumatoid arthritis across multiple disease assessments including clinical score,  paw  volume,  pannus  score,  total  histology  score  and  serum  cytokine  levels  than  the  rodent equivalent of the standard dose of HCQ or equivalent doses of CBD.

The reduction in disease assessments achieved by IHL-675A was 1.06-3.52 times that observed for HCQ alone at the standard dose.

The promising observations led IHL to prioritise rapid clinical assessment, particularly given that HCQ, marketed as “Plaquenil” and generic equivalents, is a common long-standing treatment prescribed for rheumatoid arthritis with a considerable market profile.

Primary endpoint of Phase 2 trial is pain and function

The  Phase  2  trial will  assess  the  efficacy,  safety  and  tolerability  of  IHL-675A  compared  to  the respective  component  active  pharmaceutical  ingredients  (APIs),  CBD  and  HCQ,  and  placebo.

The treatments  will  be  double  blinded,  meaning  neither  the  investigators  nor  patients  will  know  which treatment an individual is receiving.

The  study will be managed by Avance Clinical, an Australian and US contract research organisation (CRO).

Recruitment  of additional  sites  with  experience  in  rheumatology  clinical  trials  is  ongoing,  with  the  goal  of  8-10  sites  across Australia and New Zealand being included in the study.

The trial will have 128 participants who meet the eligibility criteria and is designed to include patients who have ongoing pain and reduced function while on stable treatment for rheumatoid arthritis.

Participants will be  randomised  to  one  of  four  arms including 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.

Participants  will  also  record  their  pain  and  function  outcomes  daily,  by completing questionnaires on pain, fatigue, joint stiffness, and quality of life.

The  participants  will  attend  monthly  visits  at  the  clinical  trial  site,  where  blood  tests,  and  physical examinations will monitor additional safety and efficacy outcomes including inflammatory biomarkers.

Results critical for regulatory applications

The results of the trial will be a critical component of future regulatory applications, including contributing to the combination rule assessment in the US FDA’s new drug application dossier.

“HREC approval for the Phase 2 clinical trial is a key step in the development of IHL-675A for treatment of pain and reduced function associated with rheumatoid arthritis,” IHL chief scientific officer Dr Mark Bleackley said.

“We look forward to working with Emeritus and Avance to assess the effect of IHL-
675A in this patient population.”

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 has recruited two highly experienced lead principal investigators (PIs) for the IND opening Phase-2/3 clinical trial investigating IHL-42X cannabinoid treatment of obstructive sleep apnoea (OSA).

The company has appointed Dr John D Hudson of FutureSearch Trials of Neurology, Austin, Texas and Dr Russell Rosenberg of Neurotrials Research Inc, Atlanta, Georgia.

It’s a critical step for the study as Dr Hudson and Dr Rosenberg (and their associated facilities) will serve as the first clinical trial sites for submission to the FDA and for ethics approval from Institutional Review Boards.

“Our Company is delighted to have the endorsement of two leading esteemed research scientists with the relevant experience to advance our IHL-42X drug candidate,” Incannex (ASX:IHL) CEO and MD Joel Latham said.

“Their support is testament to the efficacy of IHL-42X demonstrated in Phase-2 proof of concept studies.

“The multi-site clinical trial being arranged is a pivotal trial, meaning that it can be used for the registration of IHL-42X for regulatory registration and commercial launch, which is an exciting development for Incannex after much hard work and dedication from our broad team of contributors.” 

Potentially life-changing oral medication option

Dr Hudson has supervised over 300 clinical trials over the past 20 years mostly related to neurological issues, and founded the Austin Neurological Clinic and Sleep Medicine Consultants.

He said that obstructive Sleep Apnea affects millions of people, and remains under-treated, due in part to patients not being diagnosed, and in part due to poor patient compliance with current therapeutic modalities.

“While unheard of a few years ago, oral medications to help reduce the cause of OSA, are now undergoing further investigation,” Dr Hudson said.

“This is more than exciting, it could prove to be life-changing for many patients.”

A positive addition to the treatment landscape

Dr. Rosenberg is currently Chief Science Officer and CEO of NeuroTrials Research in Atlanta, Georgia and has more than 35 years’ experience in clinical sleep medicine and research, acting as an investigator in over 300 clinical trials including 14 in OSA and 211 in other sleep related disorders.

“Many sleep apnea patients cannot adhere to positive airway pressure therapy, use it for an inadequate period at night or just refuse it,” he said.

“Having a safe, effective pharmacological option for obstructive sleep apnea will be a positive addition to the treatment landscape as it will offer those that struggle to adhere to positive airway pressure therapy an alternative therapy.”

This article was developed in collaboration with Incannex Healthcare Limited, 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 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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