Ampio Pharmaceuticals is developing therapies for patients infected with the SARS-CoV-2 virus (COVID-19).
The U.S. Food and Drug Administration (FDA) completed its review of the Company's Investigative New Drug (IND) application for intravenous (IV) Ampion™ treatment for COVID-19 affected patients and has cleared the company to proceed with human trials.
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The Company will begin a Phase 1 clinical trial to evaluate IV Ampion as a treatment for COVID-19 patients on supplemental oxygen. The need for supplemental oxygen in COVID-19 patients is indicative of an inflammatory process in the lungs. As an immunomodulatory anti-inflammatory agent, Ampion may be effective in interrupting the inflammatory cascade associated with COVID-19 and improving the clinical course and outcome of patients.
Years of in-vitro studies on cell cultures have confirmed that the mechanism of action (MOA) of Ampion may be suitable for the treatment of inflammatory conditions, such as acute respiratory distress syndrome (ARDS) and the cytokine storm, associated with COVID-19.