COVID-19 is a disease caused by a virus called SARS-CoV-2. In severe cases, it can lead to severe inflammation and respiratory complications like acute respiratory distress syndrome (ARDS).
In ARDS, fluid from the bloodstream leaks into the lungs’ air sacs (alveoli), creating difficulties in breathing and reduced blood oxygen levels. It can also cause the body’s immune system to overreact in a cytokine storm that can further damage lung tissue through out-of-control inflammation.
Often these complications require artificial ventilation and there are currently no treatments for ARDS or the cytokine storm that follows. The mortality rate for ARDS is 50%.
The drug studied by the University of Illinois at Chicago (UIC) researchers is VT-109, an intravenous treatment. There have already been prior research on VT-109 due to awards from the National Institutes of Health, UIC, and the Harrington Discovery Institute, all of which have also recently selected VT-109 for further investment and support.
Yulia Komarova, UIC associate professor in the department of pharmacology and regenerative medicine at the College of Medicine, is the principal investigator. She had identified VT-109 after screening dozens of small molecule drugs for the potential to tighten the endothelial barrier between the bloodstream and lungs to prevent leakage of fluid into the lungs.
Komarova said, “We began developing VT-109 years ago, before the COVID-19 pandemic as a potential treatment for respiratory infections. When SARS-CoV-2 emerged and it became known that respiratory infections are major complications of COVID-19, we immediately began exploring how it could help these patients.”
Based on preclinical findings from earlier studies on animal models with ARDS, VT-109 has been shown to help restore function to damaged lungs and reduce cytokine levels. It is expected to treat pulmonary edema and restore respiratory function, improve oxygenation of the organs, and reduce lung and systematic inflammation.
VT-109 would be administered to COVID-19 patients who are in an acute phase of COVID-19 and who need different levels of oxygen support.
However, this drug is also being studied as a potential treatment for ARDS of different etiology like sepsis, burn trauma, aspiration pneumonia, and multiple transfusions, said Jaqueline Carey, Director of Health Sciences and Research Communications with UIC’s Office of Public Affairs.
“To date, we have already optimized the therapeutic candidate, developed a clinically relevant formulation suitable for COVID-19 patients with respiratory illness, and collected preliminary safety and ARDS efficacy data in mice and rats,” said Komarova.
The new funds will be used to test VT-109 on animal models of COVID-19 to determine efficacy, toxicity, and possible dosages before human trials are even considered. Following these animal studies, an Investigational New Drug, or IND, application with the US Food and Drug Administration (FDA) would be necessary to begin clinical trials in humans.
Komarova estimates that it may be three or four years before VT-109’s IND application.
“Our new pre-clinical efficacy, toxicology, and pharmacology studies of VT-109 should be sufficient to satisfy the FDA, and we are hopeful this research will culminate in acceptance of an IND application,” she said.