Ampio Pharmaceuticals announced positive results in early trial for intravenous (IV) Ampion treatment for COVID-19 patients. We believe Ampion may be effective in interrupting the inflammatory cascade associated with COVID-19 and improving the clinical course and outcome in patients treated with Ampion.

The Phase I trial was led by Michael Roshon, MD, PhD, Chief of Staff at Penrose-St. Francis Hospital in Colorado Springs, Colorado. The trial was a randomized, controlled study of adults hospitalized, confirmed SARS-COV-2 (COVID-19) positive by PCR test and receiving supplemental oxygen. Patients were randomized 1:1 to receive IV Ampion treatment or standard of care, including anti-viral therapies, such as Remdesivir or convalescent plasma, both approved by the FDA under emergency use authorization (EUA) as standard of care.  The majority of the patients in the control group were prescribed Remdesivir anti-viral treatment while no patients in the IV Ampion group received that anti-viral therapy.

The study met its primary endpoint for the safety and tolerability of IV Ampion treatment, with no remarkable difference in the incidence, frequency, and severity of adverse events between IV Ampion and standard of care.

All patients treated with IV Ampion improved after treatment. At hospital discharge, 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 scale1 and the National Early Warning Score (NEWS2), which is recommended by the National Institute for Health and Care Excellence (NICE) in its guidelines for the management of COVID-19 patients in critical care.

Treatment options for COVID-19 are limited and the country continues to observe rising numbers of infection. These Phase I study results provide encouraging results that IV Ampion may be a safe and effective treatment for COVID-19 infected patients admitted to the hospital and needing supplemental oxygen.

Patients will be followed over the upcoming months to complete the safety endpoint assessments for the Phase 1 clinical trial. Safety and efficacy results will be submitted to a peer-reviewed scientific journal and provide the basis for performing a Phase II/III trial with IV Ampion.