Manassas, VA - On June 17, 2020, Serpin Pharma was notified by the U.S. Food and Drug Administration (FDA) that it may proceed with its proposed clinical investigation for the use of SP16 to treat COVID-19 hospitalized patients. The Principal Investigator is Serpin Pharma’s collaborator,
Dr. Michael Yun Shim, John L. Guerrant Assoc. Professor of Medicine and Medical Imaging, Div. of Pulmonary & Critical Care of the University of Virginia. Dr. Larry Altstiel, acting Chief Medical Officer for Serpin Pharma, said, "SP16 is a potent new antiinflammatory drug rather than a non-specific, toxic immunosuppressive drug. SP16 reduces the production of inflammatory cytokines (e.g., IL-1β, TNF-α, IL-6) while sparing normal and protective immune function. It is effective in several animal models of acute inflammation, in particular, following a severe lung infection. Therefore, SP16, by its ability to inhibit excess cytokine production, may attenuate the development of inflammation-induced lung injury in individuals with COVID-19 infection."