July 2020: BioAegis Therapeutics Receives Approval to Proceed with Phase 2 Trial of its Gelsolin COVID-19 Treatment

MORRISTOWN, N.J., July 15, 2020 (GLOBE NEWSWIRE) — BioAegis Therapeutics Inc., announces that 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.

Clinical Protocol for Phase 2 Clinical Trial of rhu-pGSN
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. Specific details of the protocol can be reviewed at: https://clinicaltrials.gov/ct2/show/NCT04358406

According to Susan Levinson, PhD, CEO of BioAegis, “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.”

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.

Dr. Mark DiNubile, Chief Medical Officer commented, “Harnessing the body’s immune system offers an innovative approach that may lead to more effective therapies for COVID-19 and other serious infectious and non-infectious inflammatory diseases.”

National Institutes of Health is Studying Gelsolin in COVID-19 Patients
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.

About BioAegis
BioAegis Therapeutics Inc. is a NJ-based, clinical stage, private company focused on developing therapies for infectious, inflammatory and degenerative diseases through a portfolio built around gelsolin technology.

BioAegis has the exclusive license to broad, worldwide intellectual property through Harvard-Brigham and Women’s Hospital. It holds over 40 patents issued for coverage of infection, inflammatory disease, renal failure, multiple sclerosis and other neurologic diseases. BioAegis has US biologics exclusivity and has recently filed new IP.

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This press release contains express or implied forward-looking statements, which are based on current expectations of management.  These statements relate to, among other things, our expectations regarding management’s plans, objectives, and strategies.  These statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements.  BioAegis assumes no obligation to update any forward-looking statements appearing in this press release in the event of changing circumstances or otherwise, and such statements are current only as of the date they are made.