Impression Healthcare has commenced an animal study for the treatment of sepsis associated acute respiratory distress syndrome (SAARDS).
SAARDS is the leading cause of death associated with COVID-19, due to a runaway immune response which causes organ and tissue damage. The new study will test Impression’s novel treatment, IHL-675A, in suppressing this runaway response known as a cytokine storm.
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.
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 Healthcare stated in the announcement.
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 Healthcare, SAARDS is considered a leading cause of mortality associated with lung, urinary tract, stomach and skin infections.
Impression has described its latest trial as “two-pronged”. The first stage will test the individual drug components in a dose escalation study to assess the impacts of CBD and HCQ in rodents with induced sepsis. The increasing doses will be assessed for both drug efficacy and toxicity.
Following successful completion, the trial will incorporate the data from stage one to assess specific combinations of the two ingredients. The second phase of testing will attempt to pin down the best formulation of the combination drug to yield an optimal inflammation dampening response.
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 Healthcare said in a May market update.
There is currently no approved pharmacuetical treatment for SAARDS, any new standard of care for SAARDS – particularly in relation to the treatment in COVID-19 patients – will prove extremely positive for the medical profession.
While hydroxychloroquine already appears to be somewhat of a failure as a standalone treatment for COVID-19, Impression Healthcare will be hoping the IHL-675A combination study yields more positive results.
If early clinical success is achieved, Impression said it will undertake pharmaceutical development of the drug, while complying with regulatory requirements across the seven major markets of the globe, including the US FDA and the European Medicines Agency.
Source | Impression Healthcare