Medicinal cannabinoid and psychedelic medicine company Incannex Healthcare (ASX:IHL) has commenced a Phase 2 clinical trial to assess the safety and efficacy of its anti-inflammatory combination drug IHL-675A in patients with rheumatoid arthritis (RA).
IHL-675A is a fixed-dose combination drug comprising cannabidiol (CBD) and hydroxychloroquine (HCQ).
The new trial follows a Phase 1 trial in which IHL-675A was observed to be well tolerated.
Incannex says it has observed positive results from an animal model of RA.
"IHL-675A was observed to be more effective than a standard dose of HCQ at reducing arthritis across multiple assessments including; clinical score, paw volume, pannus score, total histology score and serum cytokine levels than the rodent equivalent of a standard dose of HCQ, or equivalent dose of CBD," it said.
"The reduction in disease assessments achieved by IHL-675A were 1.06-3.52 times that observed for HCQ alone at the standard dose," added the company.
The Phase 2 trial is assessing the efficacy, safety and tolerability of IHL-675A compared to the component active pharmaceutical ingredients, CBD and HCQ, and placebo. It will include 120 participants who meet the eligibility criteria.
Incannex chief scientific officer Dr Mark Bleackley said, "This trial is a key milestone in the IHL-675A development program. We are excited to continue the development of this drug product to determine whether the remarkable preclinical efficacy we observed for IHL-675A in an animal disease model for arthritis is also seen to a similar extent in humans.
"Arthritis is a disease that negatively impacts the well-being of millions of people worldwide and this trial is a big step toward Incannex potentially improving quality of life for these patients. We look forward to continuing to build our research relationship with Avance Clinical, who did an outstanding job managing the Phase 1 clinical trial assessing the tolerability and pharmacokinetics of IHL-675A in healthy volunteers."
