Inflammatory Bowel Disease

IHL-675A Inflammatory Bowel Disease

About

IHL-675A is a novel cannabinoid combination product for treatment of inflammatory diseases including inflammatory bowel disease.

Program Overview

  • Inflammatory bowel diseases involve chronic inflammation of the digestive tract with symptoms that include diarrhea, rectal bleeding, abdominal pain and cramping, and fatigue.
  • The two principal forms of inflammatory bowel disease are Ulcerative Colitis and Crohn’s Disease.
  • There are a range of drugs available to treat both the symptoms and underlying cause of inflammatory bowel disease. 
  • If the drug treatments are not effective, surgery may be required, and disease often recurs even after surgery.
  • There remain unmet needs for new therapies for inflammatory bowel disease due to price, efficacy and side-effects of available treatments.
  • IHL-675A combines cannabidiol (CBD) and hydroxychloroquine sulfate (HCQ) to target the inflammatory pathways involved in inflammatory bowel disease 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.

Addressable Market

  • Inflammatory bowel disease treatment market is expected to reach USD $22.4 billion by 2026 (7)

 

7 http://www.grandviewresearch.com/press-release/global-inflammatory-bowel-disease-ibd-treatment-market

Development

  • 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 in an animal model of inflammatory bowel disease 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 inflammatory bowel disease.
    • 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 be performed under an FDA IND.
  • Results from clinical trials will be used to seek approval via the FDA505(b)2 pathway.