Incannex Healthcare Takes Aim At Rheumatoid Arthritis
The blinded, placebo-controlled study will determine the safety and effect on pain and function of IHL-675A, aproprietary fixed-dose combination drug comprising cannabidiol (CBD) and hydroxychloroquine (HCQ).
- Incannex’s trial will be conducted across 8-10 clinical trial sites in Australia and New Zealand, and will recruit 120 patients.
- The study will assess the effect of IHL-675A on pain and function over a 24-week period using patient-reported outcomes, disease scores and inflammatory biomarker analysis.
- Results of the study will establish the safety and efficacy of IHL-675A in rheumatoid arthritis.
- Incannex will pursue a 505(b)(2) regulatory pathway for IHL-675A.
Incannex has previously demonstrated that CBD and HCQ act synergistically and believes that IHL-675A has the potential to be a multi-use drug candidate for the prevention and treatment of inflammation with applications in rheumatoid arthritis, inflammatory lung conditions and inflammatory bowel disease.
In February 2023, Incannex announced it had achieved its interim milestone of 29 patients completing primary endpoint assessments in a Phase 2 trial evaluating psilocybin-assisted psychotherapy for anxiety.
Incannex is positioned to be one of the first companies in the world to develop a proprietary psychedelic therapy.