Incannex Healthcare moves to phase 2 studies for IHL-675A following positive preliminary data
Upcoming phase 2 studies will evaluate IHL-675A in treating rheumatoid arthritis, lung inflammation and inflammatory bowel disease.
Incannex Healthcare (ASX: IHL) has completed the dosing of healthy volunteer participants in a phase 1 clinical trial to assess the safety of its multi-use anti-inflammatory drug IHL-675A.
The trial is measuring the safety and tolerability profile of IHL-675A compared to its component drugs Epidiolex (CBD) and Plaquenil (hydroxychloroquine or HCQ).
Initial testing in healthy volunteers is often sensibly required to achieve ethics approval to proceed to assessments in patients who are disease afflicted in phase 2 studies.
Three groups of 12 participants have received either IHL-675A, CBD or HCQ and all groups will be subject to identical clinical assessments.
IHL-675A was observed to be well tolerated, with no serious adverse events reported to date.
Participants will continue to be monitored until the end of October, after which blood samples collected during the study will be assessed for levels of CBD, HCQ and major metabolites to characterise the pharmacokinetics of each active ingredient.
Phase 2 studies
While the phase 1 full clinical study results will not be available until early next year, Incannex said the absence of adverse events have allowed it to commence planning and arrangement of three different phase 2 studies involving more than 100 participants.
The first study, being arranged now, will focus on patients with rheumatoid arthritis. Incannex will subsequently undertake phase 2 studies for IHL-675A in patients with lung inflammation and inflammatory bowel disease.
Incannex estimates the treatment of these three indications has a combined global annual market size exceeding US$125 billion (A$199 billion).
Rheumatoid arthritis – results from last year
In March last year, Incannex announced results from an in vivo model of rheumatoid arthritis where IHL-675A was observed to produce a more positive response in mice than that of CBD or HCQ alone.
Low dose IHL-675A was found to be up to 3.52 times more effective at reducing arthritis across multiple disease assessments, including clinical score, paw volume, pannus score, total histology score and serum cytokine levels as the standard dose of HCQ.
HCQ is already widely used to treat rheumatoid arthritis in the form of hydroxychloroquine sulphate, marketed as Plaquenil.
Incannex said an improvement in patient wellbeing achieved by IHL-675A could present a major economic opportunity for the company in the treatment of arthritis.
Market disruption
Managing director Joel Latham said the prospect of disrupting the CBD market was an exciting one for the company.
“Many people throughout the world are using unapproved CBD or cannabinoids for inflammation-based disorders,” he said.
“By undertaking pivotal clinical studies over IHL-675A, we intend to disrupt the market for CBD and open our product to the purview of medical professionals who are eminently more comfortable prescribing -approved, pharmaceutical-grade products to their patients.”