On Jul. 15, 2020, BioAegis Therapeutics announced that it received regulatory clearance from The Spanish Agency for Medicines and Health Products for its Phase 2 Proof of Concept study of its lead product, recombinant human plasma gelsolin (rhu-pGSN) in hospitalized patients with severe COVID-19 pneumonia. BioAegis expects to recruit its first patient and begin the study shortly at Hospital Universitari Sant Joan de Reus in Tarragona, Spain.

Clinical Protocol for Phase 2 Clinical Trial of rhu-pGSNThe protocol calls for a randomized, double-blind, placebo-controlled, proof-of-concept trial of recombinant human plasma gelsolin (rhu-pGSN) added to standard of care for treatment of subjects with severe COVID-19 pneumonia. Primary outcome measures will evaluate efficacy and safety.

Gelsolin is a Key Component of the Body’s Immune System Gelsolin is a human protein that is abundant in healthy individuals. It is a ‘master regulator of inflammation’. In the case of severe injury or infection, the body’s supply of gelsolin becomes depleted, which can lead to an overexuberant inflammatory response, organ damage and death, as seen in COVID-19. With the ability to replete gelsolin depleted by disease with rhu-pGSN, BioAegis is in a unique position to deliver therapeutics that have the potential to disrupt the course of the cytokine storm created by COVID-19.