IHL-675A Rheumatoid Arthritis
IHL-675A is a novel cannabinoid combination product for treatment of inflammatory diseases including rheumatoid arthritis.
- Rheumatoid arthritis is a chronic inflammatory disease where the immune system attacks healthy joint tissues leading to pain, swelling and joint stiffness. Over time this can lead to joint deformity and erosion of bone around the joints.
- The disease can also affect other tissues including skin, eyes, lungs, heart and blood vessels.
- There are several pharmacotherapies available for rheumatoid arthritis. However, inadequate response in patients, side effects and costs of available treatments create a need and desire for new treatment options.
- IHL-675A combines cannabidiol (CBD) and hydroxychloroquine sulfate (HCQ) to target the inflammatory pathways involved in rheumatoid arthritis via two different mechanisms. By combining two different anti-inflammatory drugs into a single product, IHL-675A will have more potent and broader spectrum anti-inflammatory activity than single molecule drugs.
Rheumatoid arthritis drugs market is expected to reach USD $62.9 billion by 2027. (6)
- Incannex have demonstrated that cannabidiol (CBD) and hydroxychloroquine sulfate (HCQ) synergistically reduce levels of inflammatory cytokines in both in vitro and in vivo studies.
- The CBD HCQ combination that comprises IHL-675A also reduces disease severity across multiple assessments in an animal model of rheumatoid arthritis to a greater extent than either drug alone.
- Incannex are developing IHL-675A as a unique fixed dose combination product for co-delivery of CBD and HCQ.
- IHL-675A will be assessed for safety and efficacy in a series of clinical trials in rheumatoid arthritis.
- A phase 1 clinical trial protocol was submitted to the ethics committee for review in September 2021. The clinical trial, to be conducted in Australia, is expected to commence in late 2021.
- Phase 2 and 3 studies will follow and will all be performed under an FDA IND.
- Results from clinical trials will be used to seek approval via the FDA505(b)2 pathway.