Incannex is developing a novel small molecule therapeutic IHL-675A comprising hydroxychloroquine (‘HCQ’) and cannabidiol (‘CBD’) for the potential treatment of sepsis-associated Adult Respiratory Distress Syndrome (‘SAARDS’), a major unmet clinical need and a leading cause of mortality associated with COVID-19 and other infections.
Incannex lodged a provisional patent application over IHL-675A for SAARDS with the Australian Patent Office in April of 2020 and has engaged a specialist pharmaceutical research organisation Pharmacology Discovery Services, a Eurofins Discovery Partner Lab, (‘Eurofins’) to conduct animal pre-clinical testing.
Incannex received positive results from its pre-clinical animal study for the assessment of the key constituents of IHL-675A against SAARDS. IHL-675A is hypothesised to limit the progression of infections to sepsis hyperinflammation caused by the “cytokine storm” feedback loop.
The study was designed in this manner to:
- Demonstrate the ability of Cannabidiol (‘CBD’) and Hydroxychloroquine (‘HCQ’) to inhibit inflammatory cytokine production associated with Sepsis and Sepsis Associated ARDS; and,
- assess the dose responses of CBD and HCQ to the production of cytokine inflammatory markers in rodents after inducing sepsis to benefit the design of the fixed dose combination product.
Compared to baseline mice, CBD reduced 5 key inflammatory cytokine levels by 31-90%, relative to the vehicle. Compared to baseline mice, HCQ reduced 5 key inflammatory cytokine levels by 39-88%, relative to the vehicle. 80% of results were deemed statistically significant.
Incannex is currently undertaking an in vitro study to assess the formulated combinations of CBD and HCQ that provide an optimal inflammation dampening response ratio. Results are expected in approximately 2-4 weeks. The second animal study to test for the optimal fixed dose combination will immediately follow the in vitro study.
Subject to success in stage 2 of animal studies, it is the opinion of FDA consultants Camargo Pharmaceutical Services that IHL-675A will be a candidate for FDA Emergency Use Authorisation resulting from the COVID19 pandemic. Incannex will also endeavour to supply IHL-675A under the Australian Special Access Scheme whilst it progresses its FDA data package in the pursuit of eventual product registration.
SAARDS is caused by a hyper-inflammatory response and is the leading cause of mortality associated with severe infections, including the COVID-19 coronavirus infection. There is significant unmet need in the treatment of SAARDS and there are no registered pharmacotherapy (drug) treatments available for the condition.