ENGLEWOOD, Colo. (KDVR) — An anti-inflammation drug created in Englewood has shown promise in a Phase 1 study on COVID-19 patients.
Ten patients critically ill with COVID-19 and receiving supplemental oxygen were part of the safety study conducted at Penrose/St. Francis Health Services in Colorado Springs.
Five patients were given a drug called Ampion; the other five patients in the control group were given the regular standard of care, which includes drugs like Remdesivir or Dexametson and convalescent plasma.
“When you did that calculation for the Ampion patients versus the patients who were on the standard of care, you saw that the Ampion patients did better,” said Dr. David Bar-Or, the founder and director of Ampio Pharmaceuticals.
The five patients who were given Ampion all recovered and went home. Among the five patients in the control group, one died and another remains hospitalized.
“Ampion did better than them (the control group) without Remdesivir. If anything, we are comparable to Remdesivir,” said Bar-Or.
Dr. Michael Roshon, the chief of medical staff at Penrose/St. Francis, told FOX31 that while the study size was tiny, the results were still impressive.
“We had no reason to expect that it would turn out that well. The fact that it did is really, really encouraging,” said Roshon.
Roshon said Penrose/St. Francis is now eager to begin a Phase 2 study that administers the drug not just through an IV but directly into the lungs with an inhaler known as a nebulizer that turns liquid medicine into a fine mist.
“Get the patients to breathe it in and get the drug right to the tissue that’s being harmed the most, that just makes sense,” said Roshon.
The emergency room physician called COVID-19 an assassin of the lungs, so having a way to treat lung inflammation while the world waits for a vaccine he said is critical.
“There’s a lot of bacterial problems that we have. We don’t have a vaccine for the bacterial problems but we have really effective antibiotics that stop the infection. If we could come up with something like that for COVID-19, it would be almost as good as a vaccine,” Roshon said.
The Phase 1 study in Colorado Springs was intended to first establish if Ampion is safe and well-tolerated for patients, compared to those who received the established standard of care.
According to a press release from Ampio Pharmaceuticals, “The IV Ampion treatment group had a stronger clinical improvement than the COVID standard of care control group, as determined by both the World Health Organization (WHO) clinical improvement scale and the National Early Warning Score, (NEWS2), which is recommended by the National Institute for Health and Care Excellence in its guidelines for the management of COVID-19 patients in critical care.”
Ampion was originally created to address arthritis in knee joints but Bar-Or suspected the drug could also address inflammation in the lungs and believes more studies will prove him right.
“The moment we get approval, we can scale it up significantly — very rapidly available to the public,” he said.
The CEO of Ampio Pharmaceuticals, Mike Macaluso, told FOX31 he hopes to get FDA approval later this month to begin new studies involving many more patients across the country.