IHL-675A Inflammatory lung disease
IHL-675A is a novel cannabinoid combination product for treatment of inflammatory diseases including inflammatory lung diseases such as COPD, asthma and ARDS.
- Inflammation of pulmonary tissues hinders the oxygen and carbon dioxide transfer to and from the blood via the alveoli, which are the tiny sacs in the lungs.
- Pulmonary inflammation can be caused by a range of irritants including microbes, particulate matter and chemicals.
- Inflammatory lung diseases such as asthma and COPD are the result of chronic inflammation in the lungs and are characterised by decreased lung function. Some microbial infections can also lead to severe pulmonary inflammation and acute lung injury and/or acute respiratory distress syndrome (ARDS) which result in respiratory failure.
- A range of pharmacotherapies are available for asthma and COPD. However, non-adherence is associated with poor treatment outcomes. There are no therapies available for ARDS.
- IHL-675A combines cannabidiol (CBD) and hydroxychloroquine sulfate (HCQ) to target the inflammatory pathways involved in inflammatory lung 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.
- The market for drugs targeting inflammatory lung diseases asthma and COPD is expected to reach $86.4 billion by 2025 (8)
- Global ARDS market is expected to reach $16.9 billion by 2027 (9)
- 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 pulmonary inflammation 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 lung 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.
Relevant ASX announcements
- 27 July 2021- IHL commences IHL-675A trial and patent application
- 16 July 2021- Incannex engages Procaps for production of IHL-675A
- 22 April 2021- Positive FDA pre-IND meeting guides IHL-675A development
- 4 February 2021- IHL-675A in vivo results for COPD and asthma
- 23 November 2020- Positive IHL-675A in vivo results and FDA pathway
- 5 November 2020 – Strong anti-inflammatory action from IHL-675A