Final results from phase 1 IHL-675A trial pave way for Incannex Healthcare to plan further studies
Incannex Healthcare will now proceed to a phase 2 trial assessing IHL-675A in in patients with.
Clinical-stage psychedelic and medical cannabinoid pharmaceutical company Incannex Healthcare (ASX: IHL) has received final results from a phase 1 clinical trial undertaken to assess various characteristics of anti-inflammatory drug candidate IHL-675A, which pave the way for planning of phase 2 studies.
The trial measured the safety, tolerability and pharmacokinetic profiles of the drug compared to reference listed drugs Epidiolex (cannabidiol or CBD) and Plaquenil (hydroxychloroquine or HCQ).
IHL-675A comprises CBD and HCQ in a fixed dose combination.
Three cohorts of 12 participants received either IHL-675A, CBD or HCQ with clinical assessments being identical across each arm of the trial in order to compare the individual drugs to IHL-675A, which is the proprietary combination drug including both pharmaceutical ingredients.
Participants were monitored for adverse events and had blood samples collected for pharmacokinetic analysis over a four-week period.
Well-tolerated drug
IHL-675A was found to be well-tolerated, with no adverse events of concern and no serious adverse events reported.
The same number of treatment emergent adverse events (TEAEs) were reported for IHL-675A as for Epidiolex. Minor TEAEs included abdominal pain, dizziness, fatigue, frequent bowel movements, headache and somnolence.
Pharmacokinetics of CBD
A comparison of the average pharmacokinetics of CBD in participants administered with IHL-675A compared to those administered with Epidiolex revealed that the CBD was taken up from IHL-675A more quickly and reached a higher maximum concentration in the blood.
The average maximum concentration of CBD from IHL-675A was 1.57 times higher than for Epidiolex, while the time to reach the maximum concentration was reported to be 26% faster for IHL-675A.
CBD within the IHL-675A drug was also cleared more quickly than Epidiolex.
The half-life of CBD from IHL-675A was 13% faster than Epidiolex and total exposure was similar for CBD administered as IHL-675A and Epidiolex.
Next assessment
Incannex chief scientific officer Dr Mark Bleackley said the phase 1 safety and pharmacokinetic data increased the company’s confidence in proceeding with the next assessment of IHL-675A – a 120 patient phase 2 clinical trial in patients with rheumatoid arthritis. Planning is underway for additional phase 2 trials for other inflammatory diseases because IHL-675A is considered a “multi-use” drug candidate.
“The results from the phase 1 trial are a critical milestone in the development of IHL-675A,” he said.
“Data on the safety and pharmacokinetics of the drug combination are essential for supporting a phase 2 trial which will see the administration of IHL-675A to rheumatoid arthritis patients on a daily basis over an extended period.”
He said the company was “excited to better understand” the therapeutic potential of IHL-675A as the development pipeline continues to progress.
Positive pre-clinical results
Synergistic anti-inflammatory activity of CBD and HCQ has been observed in pre-clinical studies and was used as evidence to support Incannex’s international patent application over the drug.
In pre-clinical trials including in vivo models of rheumatoid arthritis, inflammatory bowel disease and lung inflammation, IHL-675A has been shown to outperform CBD and HCQ alone.
Incannex chief executive officer and managing director Joel Latham said a large sub-group of people with rheumatoid arthritis are using HCQ or CBD to help to alleviate 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 of IHL-675A, we intend to disrupt the markets for both CBD and HCQ in treating rheumatoid arthritis,” Mr Latham added.