Monday June 22, 2020 0 comments
The U.S. Food and Drug Administration completed its review of the company's Investigative New Drug application for intravenous Ampion treatment for COVID-19-affected patients and has cleared the company to proceed with human trials.
The company said it 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, Ampio said Ampion may be effective in interrupting the inflammatory cascade associated with COVID-19 and improving the clinical course and outcome of patients.
Years of extensive in-vitro studies on cell cultures have confirmed that the mechanism of action of Ampion may be suitable for the treatment of inflammatory conditions, such as acute respiratory distress syndrome and the cytokine storm, associated with COVID-19.
Many of these research related findings have been published in peer reviewed, scientific journals, which can be found on Ampio’s website.