BioAegis Therapeutics announced it received regulatory clearance from The Spanish Agency for Medicines and Health Products (AEMPS) 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.

The 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.

“Supplementing gelsolin levels has been successful in over 20 animal models. Our recently published study in viral pneumonia revealed direct genetic evidence that this promoted lung tissue repair and down-regulated the release of injurious cytokines. After recently completing a highly successful safety study in hospitalized pneumonia patients we are looking forward to improving outcomes in severely ill COVID-19 patients,” Susan Levinson, PhD, CEO of BioAegis said.

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.

The National Institutes of Health (NIH) Clinical Center is now measuring patient gelsolin levels as part of the National Institute of Allergy and Infectious Diseases (NIAID) Strategic Plan for COVID-19 Research in an effort to better understand the immune response during the infection and convalescence phases. The NIAID research project titled, Measurement of gelsolin levels: Does plasma gelsolin correlate to clinical outcomes of COVID-19? is being led by Dr. John Gallin, Chief of Clinical Pathophysiology Section of the Laboratory of Clinical Immunology and Microbiology (LCIM). BioAegis has been engaged in a collaboration with Dr. Gallin at the NIH Clinical Center for several years and has provided materials and technology to his lab for gelsolin measurement in clinical samples.