Incannex Healthcare to begin phase 1 clinical trial for IHL-675A following ethics approval

Incannex Healthcare (ASX: IHL) has collared ethics approval, which was the final regulatory hurdle before starting a phase 1 clinical trial of its multi-use anti-inflammatory drug IHL-675A.

IHL-675A comprises a fixed dose combination of cannabidiol (CBD) and hydroxychloroquine (HCQ).

In previous in vitro and in vivo research, Incannex has demonstrated that CBD and HCQ act synergistically to inhibit production of key inflammatory cytokines. Pre-clinical studies demonstrated that IHL-675A had greater anti-inflammatory properties than CBD alone.

After evaluating its pre-clinical research data, Incannex says IHL-675A is a multi-use drug suitable to treat inflammatory lung conditions (acute respiratory distress syndrome, COPD, asthma, and bronchitis), inflammatory bowel disease and rheumatoid arthritis.

The other main component if IHL-675A, HCQ, is a “disease modifying anti-rheumatic drug” that regulates immune system activity.

It can modify the underlying disease process, including overactive immune systems, rather than just only treating the symptoms.

Rheumatoid arthritis

HCQ is marketed as Plaquenil and is already an approved treatment for rheumatoid arthritis. HCQ alone can decrease the pain and swelling in rheumatoid arthritis, while potentially preventing joint damage and reducing the risk of long-term disability.

Pre-clinical research showed IHL-675A facilitates up to a 10-times reduction in the HCQ dose without sacrificing the efficacy of treatment in an animal model of rheumatoid arthritis.

Incannex noted there is significant value in reducing the dose of HCQ in patients with arthritis because long term use is associated with cardiovascular and ocular side effects.

Phase 1 clinical study at CMAX Clinical Research

With approval from the human research ethics committee, Incannex will commence the phase 1 trial at South Australia’s CMAX Clinical Research.

Avance Clinical is managing the study, which will assess IHL-675A’s pharmacokinetics, safety and tolerability.

In readiness for the trial, Incannex has completed manufacturing of IHL-675A soft gel capsules with long-term stability studies to establish the product’s “shelf life” ongoing.

Incannex chief executive officer and managing director Joel Latham said securing ethics approval for the phase 1 trial was a “significant milestone” in advancing IHL-675A for treating people with inflammation disorders.

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

“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.”

Patient recruitment for the trial is scheduled to begin next month with three cohorts of 12 participants to receive either IHL-675A, CBD or HCQ.

Trial aim

Incannex chief scientific officer Dr Mark Bleackley said the aim of the trial is to demonstrate that there are no, or minimal, side effects of IHL-675A compared to CBD or HCQ alone.

Results from the study will form part of three US Food and Drug Administration investigational new drug (IND) applications for IHL-675A in treating rheumatoid arthritis, inflammatory bowel disease and lung inflammation.

These three indications represent a global annual market size exceeding US$125 billion.

Incannex has already completed a pre-IND meeting with the FDA to discuss the regulatory pathway for developing IHL-675A in the US.