Final results are in for a Phase 1 clinical trial to assess pharmacokinetics and the safety of Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL)’s anti-inflammatory drug candidate IHL-675A.
IHL-675A is a combination cannabinoid drug comprising cannabidiol (CBD) and hydroxychloroquine (HCQ) in a fixed dose combination.
The drug has been observed to outperform either CBD or HCQ in various pre-clinical models of inflammation, including in vivo models of rheumatoid arthritis, inflammatory bowel disease and lung inflammation.
Incannex CEO and managing director Joel Latham said: “A large sub-group of people with rheumatoid arthritis are using hydroxychloroquine or cannabidiol to help to alleviate their symptoms.
“We are delighted with the safety data and with the unique pharmacokinetic characteristics of IHL-675A that may be beneficial for patients with rheumatoid arthritis.
“By undertaking pivotal clinical studies over IHL-675A, we intend to disrupt the markets for both CBD and hydroxychloroquine as they currently pertain to the treatment of rheumatoid arthritis.”
Anti-inflammatory activity
Synergistic anti-inflammatory activity of CBD and HCQ was observed in these distinct preclinical studies, providing the evidence the company needed to pursue an international patent.
The Phase 1 trial measured 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 each received either IHL-675A, CBD or HCQ and the clinical assessments were identical across the three arms of the trial.
Participants were monitored for adverse events and had blood samples collected for pharmacokinetic analysis over a four-week period.
The trial was conducted by CMAX Clinical Research in Adelaide, South Australia and managed by Avance Clinical.
Well-tolerated drug
The trial concluded that IHL-675A was well tolerated, with no adverse events of concern and no serious adverse events reported.
The safety and pharmacokinetic data from this Phase 1 clinical trial in healthy volunteers adds to the company’s confidence in proceeding with assessment of IHL-675A in patients with inflammatory diseases.
“The results from the Phase 1 trial are a critical milestone in the development of IHL-675A,” Incannex chief scientific officer Dr Mark Bleackley said.
“We would like to acknowledge the contributions of Avance and CMAX on conducting this trial and thank the volunteers who participated in the study.
“Data on the safety and pharmacokinetics of the drug combination are essential for supporting to administration of the drug to rheumatoid arthritis patients on a daily basis over an extended period in the Phase 2 trial.
“We are excited to better understand the therapeutic potential of IHL-675A as the development pipeline continues to progress.”
Next steps
Next up is a Phase 2 trial for IHL-675A in patients with rheumatoid arthritis. As HCQ is already approved for treatment of rheumatoid arthritis, it is the first indication for which IHL-675A will be assessed during the study.
The trial will include 120 participants, randomised to one of four arms: IHL-675A, CBD alone, HCQ alone or placebo. The primary endpoint for the study is pain and function relative to baseline determined via a RAPID3 assessment at 24 weeks.
The trial will be conducted in Australia pending human research ethics committee (HREC) approval – the company will report to the ASX and the Nasdaq once it gets this green light.
Phase 2 trials are also being designed to examine the drug’s impact in patients with inflammatory bowel disease and lung inflammation.
The treatment of these three indications has a combined global annual market size of exceeding US$125 billion per annum.
Meeting with the FDA
Incannex has also filed a request for pre-investigational new drug (IND) meeting on the development of IHL-675A for treatment of arthritis with the US Food and Drug Administration (FDA).
Following the pre-IND meeting, the company intends to open an IND in parallel with the Australian Phase 2 study, allowing for the conduct of trials in the US if the Australian study continues to support the therapeutic potential of IHL-675A in patients with arthritis.
An improvement to patient wellbeing achieved by IHL-675A would potentially open a major economic opportunity for Incannex in the lucrative arthritis market.