Incannex has achieved approval to start a milestone clinical trial into its multi-use, anti-inflammatory drug to treat a range of disorders including rheumatoid arthritis.

ASX biotech Incannex Healthcare (ASX:IHL) has received approval from Bellberry Human Research Ethics Committee (HREC) for a Phase 1 clinical trial investigating its proprietary multi-use, 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 IHL’s international patent application over the drug.

The trial will be performed at CMAX Clinical Research, a dedicated and experienced clinical trial centre in Adelaide, and managed by Avance Clinical. Patient recruitment is anticipated to commence in August 2022.

Trial crucial to US FDA application

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

Three cohorts of 12 participants (total 36) will receive either IHL-675A, CBD or HCQ. The assessments will be identical across the three arms of the trial.

IHL chief scientific officer Dr Mark Bleackley said the trial will examine the drug interactions of CBD and HCQ.

“The aims of the trial are to demonstrate that there are no, or minimal, additional side effects associated with the combination of CBD and HCQ compared to each drug alone and that the uptake and metabolism, otherwise known as pharmacokinetics, of the two drugs do not materially interfere with one another,” he said.

Subject to clinical success, the results of the Phase 1 clinical trial will form part of US Food and Drug Administration (FDA) investigational new drug (IND) applications for each of the initial three indications IHL is pursuing for IHL-675A.

The indications are rheumatoid arthritis, inflammatory bowel disease and lung inflammation, representing major markets for IHL to pursue with IHL-675A.

Once the IND applications are evaluated and approved, the company intends to conduct clinical trials partly or wholly in the US.

Treatment for rheumatoid arthritis

HCQ is a disease modifying anti-rheumatic drug (DMARD) that regulates the activity of the immune system, which may be overactive in some conditions.

It can decrease the pain and swelling of arthritis, prevent joint damage and reduce the risk of long-term disability.

HCQ is approved for treatment of rheumatoid arthritis in the form of hydroxychloroquine sulphate and marketed as Plaquenil, which is one component of IHL-675A.

IHL has previously reported that the combination of CBD and HCQ in IHL-675A has the potential to permit up to a 10x reduction in HCQ dose, when combined with CBD, without sacrificing efficacy in treatment of arthritis. This was observed in an animal model of arthritis.

There is significant value in reducing the dose of HCQ in arthritis patients because, despite the drug being imperative to the patient,  long term use of HCQ in rheumatoid arthritis patients is associated with increased cardiovascular and ocular side effects. 

IHL-675A formulation and manufacturing of clinical trial supply complete

Formulation development of IHL-675A has been completed and the first batch of product manufactured.

The formulation development process included multiple experiments conducted to determine the ideal excipients to use in formulation of IHL-675A.

Other assessments included the characterisation of the dissolution of both active pharmaceutical ingredients (CBD and HCQ) from the IHL-675A gel capsule to ensure that the dissolution profile was consistent with reference listed drugs.

Data from the characterisation of the IHL-675A gel capsules, the quality assessment and early timepoints in the stability analysis were a critical component of the HREC submission package.

The results, along with data from ongoing stability studies are essential to support future regulatory submissions, including IND and new drug applications with FDA and corresponding applications with other regulatory agencies.

Stability studies to establish the shelf life of the IHL-675A gel capsule product are also underway.

Production of IHL-675A soft gel capsules can quickly ramp up to commercial quantities when required.

Milestone trial for IHL, clinicians and patients

IHL has demonstrated that IHL-675A components, CBD and HCQ, act synergistically to inhibit production of key inflammatory cytokines in an in vitro study of human cells and in four distinct successful in vivo experiments using established models of inflammation.

IHL believes IHL-675A to be a multi-use drug candidate suitable for prevention and treatment of inflammation.

The company’s initial focus is on inflammatory lung conditions, including acute respiratory distress syndrome, COPD, asthma,  bronchitis, rheumatoid arthritis, and inflammatory bowel disease.

CEO and managing director Joel Latham is optimistic. He said approval to begin its Australian Phase 1 trial is a significant milestone for IHL and clinicians treating patients with disorders for which inflammation is the underlying cause.

“There’s a growing trend whereby patients are using CBD to treat, or supplement their existing treatments, for inflammation disorders,” he said.

“We have observed in established models of inflammation that IHL-675A is a stronger anti-inflammatory cannabinoid-based drug than CBD administered alone, hence we are delighted and excited to take IHL-675A to the clinic for the first time.”

In February IHL commenced trading on the Nasdaq under the ticker code IXHL in the hopes of attracting more medicinal cannabis, and indeed biotech, investors as it pursues growth in North America.

This article was developed in collaboration with Incannex, 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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