Clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products Incannex Healthcare Limited (ASX: IHL) has completed dosing of trial participants in the phase 1 clinical trial undertaken to assess pharmacokinetics and safety of the 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 the company’s international patent application over the drug.
The trial was conducted by CMAX Clinical Research in Adelaide, South Australia and managed by Avance Clinical.
IHL-675A has been well tolerated, with no adverse events of concern reported to date. No serious adverse events have been reported. 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 pharmaceutical ingredient.
It is an exciting milestone for us to complete dosing in our Phase 1 study on IHL-675A because it has so many potential therapeutic uses,” Incannex Chief Scientific Officer, Dr Mark Bleackley said.
“At this stage, there have been no unexpected adverse events and the drug appears to be well tolerated. This gives our team the confidence to take the next steps necessary to commence Phase 2 clinical trials, initially in patients with arthritis, then in patients with lung inflammation and inflammatory bowel disease.”
Next Steps
Initial reports of drug tolerability afford Incannex the opportunity to proceed with the next stage of development for IHL-675A. As HCQ is already approved for treatment of rheumatoid arthritis, arthritis is the first indication for which IHL-675A will be assessed in a Phase 2 clinical trial of more than 100 trial participants.
Incannex is arranging a clinical trial to assess IHL-675A in arthritis patients in Australia and will update the ASX and Nasdaq once this study has formally commenced. Planning of Phase 2 studies in patients with inflammatory bowel disease and lung inflammation is underway. The treatment of these three indications has a combined global annual market size exceeding US$125B per annum.
Additionally, Incannex is preparing for a pre-IND meeting with FDA on the development of IHL-675A specifically for the treatment of patients with arthritis. Following the pre-IND meeting, the xompany 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.
In March of 2021, Incannex announced results from an in vivo model of rheumatoid arthritis whereby IHL- 675A was observed to benefit the treatment of rheumatoid arthritis in mice greater than that of CBD or HCQ alone. In fact, low dose IHL-675A was 1.06x to 3.52x 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 widely used for treatment of rheumatoid arthritis in the form of hydroxychloroquine sulphate; marketed as Plaquenil. An improvement to patient wellbeing achieved by IHL-675A would potentially open a major economic opportunity for Incannex in the treatment of arthritis.
“Many people throughout the world are using unapproved CBD or cannabinoids for inflammation-based disorders,” Incannex CEO and Managing Director, Joel Latham, said.
“By undertaking pivotal clinical studies over IHL-675A, and subject to ongoing clinical success, we intend to both disrupt the market for CBD and to open our product to the purview of medical professionals who are eminently more comfortable prescribing FDA approved, pharmaceutical grade products to their patients.”