Ampio Pharmaceuticals Inc. (NYSEAMERICAN:AMPE) has announced positive results in the initial intravenous Ampion™ treatment trial in COVID-19 patients.
Ampio’s lead drug shows potential in the treatment of hospitalized COVID-19 patients
The study showed positive results in Ampion likely to be effective in interfering with the inflammatory cascade related to COVID-19 and also improving the clinical course and patient outcome in those who received Ampion.
Michael Robinson, the Chief of staff at Penrose-St. Francis Hospital in Colorado led the Phase 1 randomized, controlled study. The trial was conducted in hospitalized COVID-19 patients who were under supplemental oxygen. The study randomized patients 1:1 to get intravenous Ampion treatment relative to standard care, including anti-viral therapies like convalescent plasma or Remdesivir, which have been approved by the FDA under EUA. Most of the control group patients received Remdesivir anti-viral treatment, and those on IV Ampion didn’t receive anti-viral therapy.
The study met the primary safety and tolerability endpoints
The trial met the primary safety and tolerability endpoints of IV Ampion treatment. There was no significant difference in the incidence, severity, and frequency of adverse effects between standard care and IV Ampion. Patients that received IV Ampion showed improvement after treatment, and the group that received Ampion had greater clinical improvement at hospital discharged compared to the COVID-19 standard care control group as determined by WHO clinical improvement scales and the National Early Warning Score.
Currently, there are few COVID-19 treatment options as the country continues to witness a resurgence of infections. The Phase 1 trial data offer the encouraging potential of IV Ampion being an effective and safe COVID-19 treatment for infected hospitalized patients in need of supplemental oxygen.
The company plans to follow up on patients in the next few months to complete the safety endpoints’ assessment for the first phase clinical trial. Ampio will submit the safety and efficacy data in a peer-review journal and offer a basis for conducting Phase 2/3 study with IV Ampion. An exclusive patent portfolio supports Ampion, the lead drug candidate of Ampion, with IP protection up to 2032.