ENGLEWOOD, Colo. (KDVR) — A pharmaceutical company in Englewood is seeking emergency approval from the FDA to test an anti-inflammation drug on COVID-19 patients.
Ampio Pharmaceuticals has been testing its drug Ampion on knee patients. Now company founder David Bar-Or, M.D., wants to switch gears and immediately start testing ventilator patients affected by coronavirus.
“Can we decrease the number of days the patient is on the ventilator and also, of course, looking at mortality to see if we can improve mortality,” Dr. Bar-Or said.
He says the anti-inflammation drug he’s been working on for 30 years should be just as effective on lungs as it is on knees.
“When I developed this drug, it was not intended for the knee. It was intended as a general anti-inflammatory,“ Bar-Or said.
If the FDA grants approval, Bar-Or said he’s ready to begin a clinical trial with 10 patients at Penrose Hospital in Colorado Springs. Five patients would get the drug Ampion and five would be treated with standard care, meaning nothing more than a ventilator.
After five days, patients’ oxygen levels would be compared to show if Ampion made a difference. If the drug showed promise, the clinical trial would quickly expand to 40 patients.
“We will see some effect within the first day,” Bar-Or predicted.
He said the drug does two things: it decreases inflammation in the lungs, and it reduces the viral load of the virus, making it less potent.
Bar-Or said the drug could be a game changer because up to 50% of all patients put on a ventilator still end up dying.
“What kills patients is not the virus itself. It’s the cytokine storm hyper-active immune response to the virus infection,” he said.
If the drug can reduce inflammation, then excess fluid won’t build up in the lungs, which often leads to death, Bar-Or said.
If the FDA grants approval, clinical trials could begin in a few weeks.