Impression Healthcare (ASX: IHL) has begun the first clinical trial to assess the effectiveness of its cannabidiol (CBD) based drug IHL-675A against sepsis associated acute respiratory distress syndrome (SAARDS), the leading cause of death related to COVID-19 infections.
This first trial is an animal study that involves using the drug to treat rodents with induced sepsis, also known as septic shock or septicaemia.
IHL-675A is a combination drug comprised of CBD and hydroxychloroquine, a historical treatment for malaria. The medical cannabis developer first unveiled the drug to the market in April, announcing it had filed a provisional patent over IHL-675A for SAARDS with the Australian Patent Office.
A leading cause of mortality
Sepsis occurs when the immune system overreacts to an infection, producing excessive levels of cytokines, which are signalling molecules that attract immune cells.
“Elevated levels of those cells secrete more cytokines, and this “cytokine storm” recruits even more immune cells, fuelling a cascading cycle that eventually damages the host tissues and organs,” Impression stated.
When the lungs are damaged by this hyperinflammatory response, SAARDS occurs. The condition is characterised by widespread inflammation of the lungs, also known as pneumonia or wet lung, which inhibits the patient’s ability to oxygenate blood.
According to Impression, SAARDS is regarded as the leading cause of death associated with the COVID-19 coronavirus infection.
SAARDS is also considered a leading cause of mortality associated with other lung, urinary tract, stomach and skin infections.
IHL-675A is hypothesised to limit the progression of infections to sepsis hyperinflammation caused by the “cytokine storm” feedback loop.
Impression described its latest trial as “two-pronged”, starting with an initial 17-arm dose escalation study to assess the dose response of the individual components of IHL-675A in animal models with induced sepsis.
The second stage of the trial will use the learnings of stage one to investigate the “optimal inflammation dampening response” of the drug by studying specific combinations of CBD and hydroxychloroquine.
In particular, the study will investigate IHL-675A on the mechanisms of inflammation in septic shock by assaying cytokine levels from blood collected across the cohorts of rodents over the two stages of the study.
Impression said results from stage one of the study are anticipated in about four to six weeks.
If a successful proof of concept in animal studies can be established, the company has been advised that IHL-675A could be a good candidate for the US Food and Drug Administration’s Emergency Use Authorisation (EUA) approval channel resulting from the COVID-19 pandemic.
“Thereafter, the company intends to conduct in-human testing concurrent with active patient prescription under EUA and Special Access Schemes globally,” Impression said in a May market update.
Current treatment for SAARDS
Impression said there has been a significant unmet need in the treatment for SAARDS for “many decades”.
The current best treatment is the use of oxygen ventilators to treat symptoms of acute respiratory distress syndrome, but this does not treat the underlying cause (sepsis).
“There is currently no registered pharmacotherapy (drug) treatment for SAARDS; however, the global medical community continues to investigate numerous drug treatments in its search for a new standard of care in response to COVID-19 coronavirus,” the company stated.