COLORADO SPRINGS — The Phase 1 trial of the anti-inflammatory drug, Ampion, has concluded at Penrose-St. Francis Hospital. Doctors there say they believe the drug is safe to use on COVID-19 patients.
Ampion is an anti-inflammatory drug, created by Ampio Pharmaceuticals in Englewood. It was developed for the treatment of pain due to osteoarthritis of the knee, and has been tested thousands of times, according to the company.
But this trial marks the first time Ampion has been tested on COVID-19 patients.
Penrose-St. Francis is the first hospital to test the drug’s efficacy on coronavirus patients, with the goal of speeding up recovery and treating complications.
In the trial, five patients were given Ampion along with standard care; another five patients, in the control group, were treated with standard care – a regimen which includes drugs like Remdesivir or Dexametson and convalescent plasma.
“In that mix, it’s hard to say what was an effect of our drug versus everything else. But we think… after enrolling the first 10 patients, that we saw no adverse events for safety that could be directly related to the drug,” said Michael Roshon, MD, PhD, Chief of Staff at Penrose-St. Francis Hospital.
Doctors say the trial was designed and focused on safety.
Although the results of the trial will not be released until November, doctors say they believe the drug is safe to use in COVID-19 patients.
“Both scales showed that we improved in patients receiving Ampion and we also improved some oxygenation parameters that are taken into account when you do scale,” said Dr. David Bar-Or, MD, Ampio Pharmaceuticals.
Doctors said many patients were eager to participate in the trial.
“Everyone has been absolutely wonderful. No one turned us down to participate in this study,” said Diane Redmond, RSN., MSN. at Penrose-St. Francis.
But the work in this particular study, isn’t over quite yet.
“We’ll typically do a check 28 days after the trial is over and then another 60 days and 90 days so we won’t know until the end of November what the firm conclusions are, but right now the indications are that they are safe for use,” said Dr. Roshon.
Doctors say Phase 2 will include more patients, and – possibly – a different way to administer the drug.
“One of the advantages that we have with this drug Ampion, is that it can be nebulized and breathed in directly to the lungs. In COVID-19 disease – that’s where the early problem is – in the lungs. We think if we can deliver a drug that can turn down the immune response directly to the tissue that’s being most affected by that immune response, then we may have a better chance of improving the outcomes,” said Dr. Roshon.
Dr. Bar-Or says the nebulized trial will be 40 patients and the next IV trial will involve around 100 patients.
“We’re learning how to stop the virus. We’ve seen the mortality go down. We’re learning how to control the spread. We’ve seen the case numbers go down. We know what to do, we need people to do it, and we need a little bit of patience for the science to catch up. But in general, the news is good,” said Dr. Roshon.
To visit Ampio Pharmaceuticals click here.
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