IHL-675A Inflammatory lung disease
About
IHL-675A is a novel cannabinoid combination product for treatment of inflammatory diseases including inflammatory lung diseases such as COPD, asthma and ARDS.
Program overview
IHL-675A is a cannabinoid-enhanced combination drug comprising hydroxychloroquine (‘HCQ’) and cannabidiol (‘CBD’). Incannex has demonstrated that IHL-675A components, HCQ and CBD act synergistically to inhibit production of inflammatory cytokines, both in vitro and in vivo, and reduce disease severity in three established inflammatory disease animal models.
The disease models that exhibited the greatest signals of efficacy relate to rheumatoid arthritis, inflammatory lung conditions and inflammatory bowel disease. The treatment of these indications has a combined global annual market size exceeding US$125B per annum.
Incannex has completed a phase 1 clinical trial to measure the safety, tolerability, and pharmacokinetic profiles of IHL-675A compared to the FDA reference listed drugs, Plaquenil (HCQ) and Epidiolex (CBD).
Incannex has completed a phase 1 clinical trial to measure the safety, tolerability, and pharmacokinetic profiles of IHL-675A compared to the FDA reference listed drugs, Plaquenil (HCQ) and Epidiolex (CBD).
Three cohorts of 12 participants (n=36) received either IHL-675A, CBD or HCQ and the clinical assessments were identical across the three arms of the trial. At the conclusion of the trial, Incannex observed IHL-675A to be well tolerated, with no adverse events of concern or serious adverse events.
IHL-675A has displayed superior anti-inflammatory activity compared to CBD and HCQ in a mouse model of pulmonary inflammation. In this model, groups of mice were each pre-treated with either CBD, HCQ, or IHL-675A prior to inflammatory stimulus using bacterial lipopolysaccharide. The lungs were flushed with a saline solution 24 hours after LPS administration and this fluid (bronchoalveolar lavage fluid (‘BALF’)) was analysed for inflammatory cytokine levels using a Luminex based assay.
IHL-675A reduced levels of all assessed inflammatory cytokines IL-1β, IL-6, TNF-α, CXCL1 and MCP-1 to a greater extent than either CBD or HCQ alone. White blood cell (WBC) counts, representative of inflammatory activity, also reduced more than CBD or HCQ alone.
The Global COPD and asthma drugs market is expected to reach US$50.4B by 2022, growing at a CAGR of 3.7% from 2016 to 2022.
The Global COPD and asthma drugs market is expected to reach US$50.4B by 2022, growing at a CAGR of 3.7% from 2016 to 2022.
Addressable Market
- 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)
9 www.ihealthcareanalyst.com/global-acute-respiratory-distress-syndrome-devices-market/
Development
Incannex is planning a phase 2, blinded, placebo-controlled clinical trial to determine the safety and efficacy of IHL-675A cGMP soft gel capsules in patients with conditions related to lung inflammation, including: acute respiratory distress syndrome, COPD, asthma, and bronchitis.
IHL-675A comprises a combination of HCQ, an expired patent registered pharmaceutical drug, and CBD. HCQ is a disease modifying anti-rheumatic drug that regulates the activity of the immune system, which may be overactive in some conditions. HCQ can modify the underlying disease process, rather than simply treating the symptoms.
Incannex has demonstrated that IHL-675A components, CBD and HCQ act synergistically to inhibit production of key inflammatory cytokines in an in vitro study of human cells and in four distinct successful in vivo experiments using established models of inflammation.
In a pre-IND meeting, the US FDA has agreed that marketing applications for IHL-675A should be 505(b)(2) applications. A 505(b)(2) New Drug Application (‘NDA’) contains full safety and effectiveness reports but allows some of the information required for NDA approval, such as safety and efficacy information on the active ingredients, to originate from historical studies not conducted by Incannex.
This will result in an accelerated and less-costly route to approval, compared with a traditional development path [505(b)(1)], whilst creating new and differentiated commercial products, subject to clinical success.