Month: August 2023

Clinical-stage pharmaceutical company Incannex Healthcare (ASX: IHL) has received approval from the US Food and Drug Administration (FDA) to conduct an investigational new drug (IND) opening trial for lead candidate IHL-42X in the US.

The pivotal Phase 2/3 trial will assess the effect of IHL-42X in obstructive sleep apnoea (OSA) patients who are non-compliant, intolerant or naïve to positive airway pressure treatment, such as that administered by CPAP (continuous positive airway pressure) devices.

It has been deemed safe to proceed following the FDA’s assessment of the trial protocol, lead trial investigators and a risk benefit analysis of the trial and prospective product.

Incannex is continuing preparations for the trial’s start-up process which includes finalisation of institutional review board (IRB) applications and submissions for lead clinical trial sites.

Site selection, approvals and IRB submission for additional study sites will be conducted at the same time.

Synergistic combination

IHL-42X is a synergistic composition of dronabinol (a synthetic form of tetrahydrocannabinol (THC) and acetazolamide (a carbonic anhydrase inhibitor).

Participants in the Phase 2/3 trial will receive one dose of IHL-42X, dronabinol, acetazolamide or placebo for the entirety of the trial.

They will complete daily surveys on their sleep quality; and attend monthly clinic visits to assess functional outcomes of sleep, cognitive function and other measures of safety and efficacy.

Every three months, overnight polysomnography will be conducted to determine the effect of treatment on the patients’ apnoea hypopnea index (AHI) along with a range of other sleep parameters.

All drug treatments will be compared to placebo.

Concept trial

Results from a Phase 2 proof of concept clinical trial by Incannex were released last year and found that the drug reduced patient AHI by an average of 50.7% versus baseline assessments, with 25% of participants experiencing a reduction of more than 80%.

No serious adverse events were reported during the trial.

Most common disorder

OSA is the most common of all sleep-related breathing disorders.

It involves the narrowing of the upper airway during sleep, interfering with a person’s breathing, decreasing oxygen uptake and resulting in poor-quality sleep.

Untreated OSA can lead to serious long-term adverse health outcomes including hypertension, cardiovascular disease, heart attack, cognitive impairments, anxiety and depression, irritability and daytime fatigue increasing the risk of accidents.

There are no pharmacotherapy (drug) treatments available to those afflicted.

Incannex said it expected “greatly improved treatment compliance” and outcomes for OSA patients from a pharmaceutical product such as IHL-42X.

Article credit: SmallCaps | By Imelda Cotton – August 24, 2023

Incannex Healthcare (ASX: IHL) subsidiary Psychennex Pty Ltd has started preparing an investigational new drug (IND) application to the US Food and Drug Administration (FDA) for a psilocybin-assisted psychotherapy development program (Psi-GAD).

The submission will include five detailed modules on the safety and efficacy of psilocybin-assisted psychotherapy across a range of mental health indications.

The FDA’s review process involves the evaluation of the modules to ensure that the drug product and proposed clinical trial meet regulatory requirements.

Psychennex will also include comprehensive data on the development, quality and stability of Incannex’s psilocybin drug product and the design of a proposed IND opening study.

Interim analysis

In March, Incannex announced an interim analysis for a Phase 2 Psi-GAD clinical trial being conducted at the Brain Park clinical psychedelic lab within Melbourne’s Monash University.

Interim data predicted a greater than 85% chance of the trial showing statistically significant benefit for the psilocybin treatment arm versus the placebo arm at the conclusion of the trial period.

An independent data safety monitoring board was appointed to review data from the first 37 out of a total 72 participants in the trial and recommended no adjustments to the original study design or sample size.

The trial and monitoring board teams identified no safety concerns at the time and allowed the trial to continue as designed.

Final results from the Psi-GAD clinical trial are expected by early next year.

Key regulatory approval

Incannex managing director Joel Latham welcomed the IND process for Psi-GAD as a key regulatory approval needed to undertake clinical trials in the US.

“Commencing IND preparations demonstrates our confidence in the utility of the Psi-GAD therapy,” he said.

“The interim analysis and the progress made by Dr Liknaitzky and his team at Monash University has empowered us to fast-track various strategic business decisions to hasten the development of the therapy.”

Mr Latham said Incannex was “consistently fortifying” its position as a frontrunner within the psychedelic research sector.

Article credit: SmallCaps | By Imelda Cotton – August 24, 2023

Incannex Healthcare’s (ASX: IHL) subsidiary, Clarion Clinics Group, has begun accepting registrations of interest from potential patients for two new psychedelic-assisted therapy (PAT) treatments at its website clarionclinics.com.

The PAT treatments are intended to assist patients with treatment resistant depression (TRD) and post-traumatic stress disorder (PTSD) using psilocybin and MDMA in an Australian first clinic comprising experienced psychiatrists and psychologists, who in many cases have strong academic backgrounds.

Initial steps and expectations

“This is the first step in the process towards receiving treatment and we anticipate that there will be a high level of interest in our leading-edge treatments,” said Incannex’s director responsible for Clarion, Peter Widdows.

Treatments will be conducted in Clarion’s purpose-designed clinic, which is currently in the final fit-out stage at its location close to Melbourne’s city centre.

The clinic features seven treatment rooms and other facilities conducive to psychedelic-assisted therapy.

“A lot of thought went into the design of the clinic, as both practical and aesthetic considerations are very important for this type of treatment. It’s imperative that clients feel welcome, comfortable and safe. We wanted the design of the space to support a sense of calm and a positive mindset, as we know these things contribute to better treatment outcomes,” Mr Widdows said.

Treatment program and team

As well as taking advantage of this specially designed facility, the company’s clinical leadership of Dr Paul Liknaitzky, Professor Suresh Sundram and Sean O’Carroll have developed a bespoke nine-month long treatment program.

“Our evidence-informed treatment protocols, professional team, and experience within research trials will soon be in service of our clients and the best possible treatment we can provide,” Dr Liknaitzky said.

Due to the nature of the psychedelic compounds to be used in Clarion’s PAT protocol, the team’s psychiatrists must be approved under the TGA’s Authorised Prescriber Scheme.

“The recent guidance from the Royal Australian and New Zealand College of Psychiatrists in regards to PAT are part of the process towards the safe and effective provision of clinical psychedelic care to the many people who are without adequate treatment options for serious mental health conditions,” said professor Suresh Sundram, Clarion director and head of psychiatry.

Understanding PTSD and other mental health issues

According to Australian health authorities, an estimated 12% of Australians will suffer from PTSD at some point in their lifetime, and 1.5% of the population (390,000 people) have a PTSD diagnosis at any given time.

Studies have identified that certain groups such as people who serve in the defence force, military veterans, first responders, and certain minority groups make up a disproportionate share of people who experience this debilitating mental health disorder.

A new approach to treatment-resistant cases

Dr Liknaitzky said that along with many PTSD sufferers, it is estimated that 26.5% of Australians who suffer from depression do not adequately respond to standard treatments.

“The term ‘treatment-resistant’ has misleading connotations, implying that all avenues have been exhausted and that front-line treatments work well for everyone else.”

“In reality, neither are typically true. For people who have suffered with certain conditions that have not responded to available treatments, psychedelic-assisted therapies may provide substantial improvements to negative symptoms and quality of life,” Dr Liknaitzky added.

Clarion Clinics

The first ‘model clinic’ in Abbotsford, Melbourne, is nearing fit out completion.

Clarion Clinics has planned to open many more clinics in major cities across Australia.

Clarion’s bespoke protocol involves a thorough pre-treatment assessment process, including psychiatric evaluation and diagnosis, medical assessment, and psychological assessment.

If accepted for treatment, the client will be treated over a period of 9 months of psychotherapy, including certain psychotherapy sessions that include dosing with psychedelics.

Written by: Colin Hay. Credit: Small Caps.

Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL) chief scientific officer Dr Mark Bleackley tells Proactive the company has completed a constructive pre-Investigational New Drug (IND) application meeting with the US Food and Drug Administration (FDA) for its IHL-675A proprietary drug targeted at the treatment of rheumatoid arthritis (RA). IHL-675A is a combination of cannabidiol (CBD) and hydroxychloroquine sulphate designed to address inflammatory disorders including RA. A successful IND application is a requirement to conduct trials in the US and ensures trials are designed to meet data requirements for future FDA approvals.

Written by: Andrew Scott. Credit: Proactive.