Month: March 2023

IHL is undergoing a pivotal point in its journey as a company moving from pure research to service delivery as Australia becomes the first country to recognise psychedelics as medicine.

Incannex Healthcare (ASX: IHL) has announced that it has developed plans for the commercialisation and launch of multiple psychedelic-assisted psychotherapy clinics, the first of which will open in Melbourne in 2023.

Incannex is at an advanced stage of negotiation on riverfront premises for its first clinic in Melbourne and hopes to roll out many more as the market potential is what it has referred to as a “multi-billion dollar opportunity”.

IHL said it has been developing commercialisation plans for psychedelic clinics for some time, well before the Therapeutic Goods Administration (TGA) decision to down-schedule psilocybin for treatment-resistant depression (TRD) and MDMA for Post-Traumatic Stress Disorder (PTSD) was announced.

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

“When the TGA announced the down-scheduling of MDMA and psilocybin for two indications, we were in a perfect position to expand our plans to cover this wider set of related therapies for certain indications,” Widdows said.

“This is both an amazing opportunity to do some good for humankind by delivering high-quality, effective treatments for  debilitating conditions that often don’t respond to available treatments, and a great business opportunity, with a market that is predicted to mature into a multi-billion-dollar industry segment.”

Partnerships with clinical professionals

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

Co-founder, director, chief strategy, and chief scientific officer Paul Liknaitzky has played a central role in establishing the clinical psychedelic field in Australia and leads the largest group of psychedelic researchers and clinicians in the country.

He is the chief principal investigator on a program of psychedelic trials and collaborates on numerous others nationally.

He has led the development of psychedelic trial protocols, treatment design, trial coordination, therapist selection and training, and has established active collaborations with an extensive network of international experts and organisations in the field.

His work is focused on developing innovative therapies, evaluating benefits, exploring potential drawbacks, predicting treatment response, mitigating risks, understanding therapeutic mechanisms, and translating research into practice.

“The safe, useful, and ethical translation of clinical psychedelic research into practice has been at the forefront of my mind for some years, as we conduct trials and learn first-hand about the potential and the complexity of providing  psychedelic therapies,” Liknaitzky said.

“Very few people in Australia have the unique expertise and experience in delivering psychedelic therapies, and it is incumbent on those who do, to set the highest standards in patient safety, quality of care, ethical conduct, and accessibility.”

Leading transition to psychedelic-assisted psychotherapy

Co-founder, director chief medical officer and head of psychiatry Professor Suresh Sundram has led more than 50 clinical trials and studies in psychiatric disorders and has extensive experience with the use of psychedelics within psychotherapy.

“The down-scheduling of certain psychedelic treatments for certain conditions is an important  transition point to establish the  utility and role of psychedelic-assisted psychotherapy in mental illness,” Sundram said.

“Providing a custom-tailored environment to deliver the best possible therapeutic experience is critical.

“To enable this, and to evaluate and deliver outcomes, is a rare opportunity.”

Co-founder, director and head of psychotherapy Sean O’Carroll is an integrative psychotherapist and academic specialising  in  experiential, relational, and transpersonal psychotherapy.

Since 2019, he has developed and delivered psychedelic-assisted psychotherapy training for several clinical psychedelic research  teams.

O’Carroll began lecturing in transpersonal psychology in 2011 and has more than 10 years’ experience working with what he calls “psychedelic casualties”.

Through the Wild Mind Institute, he offers training for mental health practitioners in psychedelic-assisted psychotherapy, “bad trip” integration, and eco-psychotherapy.

“Many of us in the research community were surprised by the recent TGA announcement, understanding this research is still in its early stages here in Australia, and that a good deal of necessary infrastructure is not yet in place,” O’Carroll  said.

“With this decision, those of us who have the experience and  expertise in this field feel a responsibility to contribute to the best  possible care and provide a benchmark for safe and ethical practice. “

“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.”

Pivotal point in IHL’s journey

IHL is at an advanced stage of negotiations over locations in Melbourne with the first model clinic expected to open before the end of 2023.

Once the operation of the model clinic is running smoothly, IHL plans to begin rapid expansion within Australia and overseas, where legislation allows.

“This opportunity is something the IHL team have been working towards for some time now and presents a pivotal point in the journey of the company, turning from pure research into service delivery,” IHL managing director and CEO Joel Latham said.

“The opportunity is to deliver the highest-quality care and make a real difference in people’s lives, alongside substantial and imminent revenue potential.”

He said implementation of Psychedelic Clinics won’t impact development of its core clinical assets and will be run as an IHL-owned subsidiary in parallel.

IHL is currently undergoing a Phase 2 clinical trial for its proprietary psilocybin-assisted psychotherapy program for Generalised Anxiety Disorder (GAD), in a clinical trial program also known as “PsiGAD”.

“Implementation of this strategy will in part provide the platform to allow an accelerated path to commercialisation for our drug assets post clinical success,” 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.

The post Incannex to open psychedelic psychotherapy clinic’s business with leading Australian psychedelics experts appeared first on Stockhead.

Even though specific data from the PsiGAD trial cannot yet be released until the trial is completed, positive interim results of the Phase-2 clinical trial has given Incannex the encouragement to commence drafting an FDA IND application

Incannex Healthcare (ASX:IHL) says that an interim review of its clinical trial data has indicated no safety concerns, and even projected a statistically significant benefit for the psilocybin treatment arm versus the placebo treatment arm in those patients who have completed the treatment.

The pharmaceutical cannabinoid and psychedelics company is currently undergoing a  Phase-2 clinical trial for its proprietary psilocybin-assisted psychotherapy program for Generalised Anxiety Disorder (GAD), in a clinical trial program also known as “PsiGAD”.

From the interim data so far, IHL found there is a high probability (greater than 85% with 95% confidence level) that the  study, when completed, will show a statistically significant benefit for the psilocybin treatment arm over the placebo treatment arm.

This projection is made by assuming the effect size observed in the current 29 participants will be representative of the effect size through the remaining 43 participants of the 72 person trial.

First announced in December 2020,  this Phase-2 study is a world-first clinical trial conducted through a partnership between Incannex and Monash University, and is led by Dr Paul Liknaitzky, a Research Fellow at the University.

“The results from the interim analysis of our Phase-2 clinical trial provide us with encouragement that our PsiGAD psilocybin-assisted psychotherapy treatment protocol has the potential to transform the lives of people suffering from anxiety,” said Incannex CEO, Joel Latham.

“Even though the results must remain blinded until the conclusion of the trial, the confidential review has given us the confidence to commence manufacture of our own psilocybin drug product with the appointment of Catalent, progress planning of our pivotal trials and commence drafting our FDA IND application for the PsiGAD treatment program.

“The Clinical Psychedelic Lab at Monash University has overseen training of 14 psychotherapists to work on the phase 2 trial, demonstrating that this transformational treatment is scalable to many therapists and patients throughout the world.”

A huge market opportunity to treat GAD

GAD affects millions of people across the globe each year, and is characterised by excessive anxiety and worry that occurs more days than not for at least 6 months.

The disease is not restricted to any particular environmental circumstances, and symptoms include feelings of persistent and excessive worry, nervousness, restlessness, difficulty concentrating, and a range of somatic manifestations.

People with GAD find it difficult to control their worry, which may cause significant distress and impairment in social, occupational, or other areas of functioning.

And as with other mood disorders, current treatments of GAD remain inadequate, with less than half of patients achieving remission following evidence-based treatment, alongside high relapse rates, and substantial treatment side-effects or cost.

Incannex’ psilocybin-assisted psychotherapy aims to address this market gap by using psilocybin to improve the effectiveness of psychotherapy for GAD sufferers.

The treatment in the Phase-2 trial involves two administrations of psilocybin in conjunction with psychotherapy, in a controlled clinical setting as part of a 10-week course of specialised treatment.

Commencement of FDA application

The trial employs a team of experienced and qualified clinicians and researchers who undergo specialist training before they deliver and assess the treatment.

To date, over 45 participants have been enrolled in the study, with 29 participants having now completed the treatment protocol and main outcome assessment following treatment.

Treatment of all 72 trial participants is anticipated to be completed in the fourth quarter of 2023.

The end point used in the study was a reduction in Hamilton Anxiety Rating Scale (HAM-A) score at 11 weeks relative to baseline, which is the primary endpoint in the trial.

The HAM-A was one of the first rating scales developed to measure the severity of anxiety symptoms, and is still widely used today in both clinical and research settings.

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.

The post Incannex’s interim data predicts a statistically significant benefit for psilocybin therapy over placebo when treating anxiety, FDA IND application now in sight appeared first on Stockhead.

Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL) CEO Joel Latham tells Proactive the company has begun a Phase 2 clinical trial, testing the safety and efficacy of its IHL-657A drug candidate in patients with rheumatoid arthritis. Research firm Avance Clinical will manage the trial across up to 10 sites in Australia and New Zealand, overseeing responses from 120 participants as they evaluate how IHL-657A treats patient pain and function over 24 weeks.

Reference article: YouTube

Feb 28, 2023

Catalent will formulate and manufacture Incannex’s psilocybin drug for use in clinical trials and potential commercialisation.

Incannex Healthcare (ASX: IHL) has reached another milestone in progressing its psilocybin drug product by engaging Catalent to formulate and manufacture the drug for use in clinical trials.

Incannex also staged the supply will also be used for potential wider commercialisation following recent down-scheduling of psilocybin by the Australian regulator, Therapeutic Goods Administration (TGA) for prescription by authorised psychiatrists starting from 1 July this year.

Under the agreement, Catalent will develop and manufacture a pharmaceutical grade psilocybin drug in accordance with current good manufacturing practice (cGMP) regulations.

As part of the process, Catalent will develop the formula, and generate the required quality and stability data for regulatory filings.

Catalent will design the manufacturing process so that it can be scalable to commercial-scale levels when required.

Once manufactured, Incannex will initially use the drug in its ongoing proprietary psilocybin-assisted psychotherapy drug development program.

Incannex managing director and chief executive officer Joel Latham said the agreement with Catalent will provide the company with its own source of pharmaceutical-grade psilocybin for its clinical trials and “a number of commercial opportunities.”

Mr Latham added the commercial opportunities are at an “advanced stage of investigation” and will be announced “in the coming weeks” following board evaluation and approval.

Psilocybin-assisted psychotherapy clinical trials

Incannex has initiated an ongoing psilocybin-assisted psychotherapy clinical trial program for treating generalised anxiety disorder (PsiGAD).

A review of interim data from the phase two PsiGAD trial has given Incannex the confidence to proceed with engaging Catalent to formulate and manufacture the drug.

This review began in January this year after the trial achieved its interim milestone of 29 patients completing primary endpoint assessments.

The PsiGAD trial was developed in collaboration with Monash University’s head of the Clinical Psychedelic Lab Dr Paul Liknaitzky.

Dr Liknaitzky is also a member of Incannex’s scientific advisory board.

The PsiGAD study comprises a 10-week treatment program at Monash University’s BrainPark. The treatment program includes two dosing sessions with either psilocybin or active placebo.

By the end of January, 45 participants had been enrolled in the trial, which continues to progress well and on time with no safety concerns.

Safety, efficacy, quality of life and other aspects of mental and physical health are being assessed as part of the study.

Incannex’s chief scientific officer Dr Mark Bleackley said the company’s therapy could potentially help millions of people whose lives are seriously impacted by severe anxiety and where current options are ineffective.

Reference article: Small Caps

March 3, 2023

As Australia becomes the first country to recognise psychedelics as medicine, Incannex Healthcare is going to start manufacturing its own psilocybin drug product, boosting both trial and commercial opportunities.

Clinical stage pharmaceutical cannabinoid and psychedelics company Incannex Healthcare (ASX:IHL) has engaged Catalent to develop and manufacture cGMP-grade psilocybin drug product.

IHL said the product will be used in its proprietary psilocybin-assisted psychotherapy drug development program along with potential wider commercial use.

Development and manufacture of a psilocybin drug product follows an internal analysis of the interim data from its PsiGAD Phase 2 clinical trial, giving IHL confidence to proceed with formulation development and pharmaceutical-grade manufacture of its own psilocybin.

Incannex’s PsiGAD Phase 2 clinical trial is assessing its psilocybin-assisted psychotherapy for treatment of generalised anxiety disorder (GAD), often known as a severe form of anxiety.

PsiGAD is the most advanced clinical trial in Australia with 72 patients undertaking the psychedelic-assisted psychotherapy trial at Monash University. IHL has already sought FDA guidance on the trial through a pre-IND meeting completed in 2021.

Interim results from the PsiGAD trial have been received by IHL but remain internally confidential to maintain blinding and integrity of the trial, however, a report from the independent data safety monitoring board (DSMB) on the interim results is expected to be released soon.

Trials and commercial opportunities boost

Australia has become the first country in the world to recognise psychedelics as medicine, after the Therapeutic Goods Administration (TGA) approved psychedelic substances used in magic mushrooms and MDMA.

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 certain mental health conditions.

The move is a welcome move by IHL. CEO and managing director Joel Latham said having its own source of pharmaceutical grade psilocybin enables the company to freely undertake clinical trials.

“It also creates and assists with several commercial opportunities which are at an advanced stage of investigation by the company, and will be announced in the coming weeks, following board appraisal and approval,” he said.

Catalent has been engaged to develop the formulation, generate required quality and stability data for regulatory filings, and establish cGMP manufacture of a drug product to be used in future clinical trials.

The proposed manufacturing process will be designed so that it will be scalable to commercial supply levels when appropriate.

“Engaging Catalent for development and cGMP manufacture of Incannex’s psilocybin drug project is an important milestone for the PsiGAD program,” IHL chief scientific officer Dr Mark Bleackley said.

Incannex also has a licensing arrangement with Monash University over a VR environment that it intends to use as a VR therapy tool in combination with psychedelic drugs to develop a new treatment for other severe forms of anxiety disorders.

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.

The post Incannex commences manufacture of psilocybin for trials and commercial applications appeared first on Stockhead.

A total of 120 patients will be recruited for the trial of IHL-675A in rheumatoid arthritis.

Medicinal cannabinoid and psychedelic therapies developer Incannex Healthcare (ASX: IHL) has commenced a phase 2 clinical trial to assess the safety and efficacy of its proprietary anti-inflammatory combination drug IHL-675A in patients with rheumatoid arthritis.

The trial is being managed by Avance Clinical and will engage up to 10 sites across Australia and New Zealand, recruiting 120 patients in total, making it one of the largest clinical trials conducted in the sector.

The trial will assess the effect of IHL-675A on pain and function by utilising patient-reported outcomes, disease scores and inflammatory biomarker analysis over a 24-week period.

Patients who meet the criteria for joint damage may also be included in a magnetic resonance imaging (MRI) assessment sub-study.

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

HCQ is approved for treatment of rheumatoid arthritis and is used by a significant cohort of patients with the disease. Many are also reportedly using non-cGMP grade CBD to ameliorate their symptoms.

The intention of Incannex is to undertake clinical trials for its proprietary fixed dose combination of HCQ and CBD to achieve the US Food and Drug Administration (FDA) marketing approval for a pharmaceutical grade IHL-675A product that can be prescribed with confidence by a patient’s doctor.

Prior to conducting this phase 2 trial, IHL-675A was reported to be well tolerated in a phase 1 trial. In animal studies, IHL-675A was observed to reduce arthritis disease scores to a greater extent than HCQ.

Animal model

The animal model of rheumatoid arthritis showed IHL-675A to be more effective than a rodent equivalent, standard dose of HCQ at reducing inflammation across multiple assessments including: clinical score, paw volume, pannus score, total histology score and serum cytokine levels.

The reduction in disease assessments achieved were up to 3.52 times that observed for HCQ alone at the standard dose.

These observations led Incannex to prioritise the rapid clinical assessment of IHL-675A, particularly given that HCQ is a common long-standing treatment prescribed for rheumatoid arthritis.

Safety and efficacy

Incannex chief scientific officer Dr Mark Bleackley said the phase 2 trial would seek to establish the safety and efficacy of IHL-675A and contribute to a new drug application dossier for the FDA.

“This trial is a key milestone in our IHL-675A development program [and] we are excited to determine whether the remarkable preclinical efficacy observed in an animal disease model for arthritis is also seen to a similar extent in humans,” he said.

“Arthritis is a disease which negatively impacts the well-being of millions of people worldwide and this trial is a big step toward [us] potentially improving the quality of life for these patients.”

Multi-use drug

IHL-675A is being developed as a multi-use drug suitable for the prevention and treatment of inflammation, with an initial focus on rheumatoid arthritis, inflammatory lung conditions (including acute respiratory distress syndrome; chronic obstructive pulmonary disease; asthma; and bronchitis); and inflammatory bowel disease.

The treatment of these indications is believed to have a combined global market size of more than US$125 billion per year.

Incannex has completed a pre-investigational new drug (IND) meeting with the FDA to discuss the regulatory pathway for the development of IHL-675A in the US and plans to open INDs for each of the three indications.

HCQ is already approved for the treatment of rheumatoid arthritis and is used by a significant cohort of trial patients with the disease.

Subject to clinical results, if IHL-675A proves to be more efficacious than HCQ alone, then IHL may have landed on a better alternative medicine for patients with rheumatoid arthritis.

Reference article: Small Caps

February 28, 2023