Colorado company wins FDA approval for COVID-19 clinical study

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ENGLEWOOD, Colo. (KDVR) — An anti-inflammatory drug will soon be tested on COVID-19 patients at Penrose Hospital in Colorado Springs. Englewood-based Ampio Pharmaceuticals has won FDA approval to do a clinical study using its drug Ampion.

“I am ecstatic,” said Dr. David Bar-Or, the CEO of Ampio Pharmaceuticals. 

The clinical trial will begin small, with just 10 patients, in July. Five patients will receive Ampion and five will not.

“Hopefully it prevents a patient who needs oxygen from having to be put on a ventilator,” said Bar-Or, who said Ampion works by reducing inflammation in the lungs so patients can breathe better.

Bar-Or said patients who end up on a ventilator still die 40-50% of the time, so Ampion will be given both to patients on a ventilator and to patients before they need a ventilator.

Patients will be given two doses a day for five days.

“What I expect to see is something very rapidly — something happen very rapidly. Improvement in oxygenation parameters and perhaps the well-being of the patient,” said Bar-Or before adding, “When we do in-vitro studies in cell cultures, we see the results within 24 hours.” 

If patients’ results show promise, the study will be expanded to four other hospitals.

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