May, 2020: Study of BioAegis’ Lead Product, Gelsolin, is Key Component of NIAID Strategic Plan for COVID-19 Research

MORRISTOWN, N.J., May 21, 2020 (GLOBE NEWSWIRE) — BioAegis Therapeutics Inc. announces that the National Institute of Health (NIH) Clinical Center is measuring patient gelsolin levels as part of the NIAID Strategic Plan for COVID-19 Research. BioAegis’ lead product, recombinant human plasma gelsolin (rhu-pGSN), is based on this highly abundant circulating human protein. This study is a critical step in a large international collaborative to understand the immune response during COVID-19 infection and convalescence.

National Institute of Health Clinical Center to Study Gelsolin Levels
The National Institute of Allergy and Infectious Diseases (NIAID) research project, 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). According to the project overview, “Plasma gelsolin is thought be an important anti-inflammatory protein…Low levels correlating with mortality could be an important biomarker for disease and may suggest a potential therapeutic role for exogenously administered gelsolin.”

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.  According to Susan Levinson, PhD, Chief Executive Officer of BioAegis Therapeutics, “We know that blood levels of gelsolin are depleted by many infections and injury and that it predicts the likelihood of poor outcomes in patients. It is logical to assess levels in COVID-19 patients along with their immune response and we are pleased that the NIAID has recognized gelsolin’s potential as a biomarker and therapeutic as part of their strategic plan.  This data will be valuable in our upcoming COVID-19 clinical trials.”

Gelsolin Supplementation is a Viable Treatment for COVID-19
BioAegis’ lead product, rhu-pGSN, has enormous potential to prevent debilitating and potentially lethal ravages of inflammation in patients with severe COVID-19. This strategy, rather than being a narrowly targeted pharmaceutical intervention, involves replenishing an already existing component of the immune system, without compromising its essential function to fight infection and promote repair.

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.

Gelsolin’s efficacy has been demonstrated in over 20 animal studies for multiple indications, including a recent study conducted in collaboration with investigators at the Harvard T.H. Chan School of Public Health in severe influenza pneumonia. In addition to significantly increasing survival, this study showed gelsolin-treatment led to less active (downregulated) inflammatory genes and increased activity (upregulated) in genes that promote tissue repair. Gelsolin has also been shown to protect the lung from infection and injury.

Access influenza publication here: Rhu-pGSN in Severe Influenza Pneumonia

A recent Phase 1b/2a study in hospitalized community-acquired pneumonia patients has been completed with no adverse safety signals. This data together with the sizable body of previously published research gives substantial credence to the potential for gelsolin supplementation with rhu-pGSN to prevent the morbidity and mortality seen in the ongoing COVID-19 pandemic.

BioAegis Is Developing Gelsolin to Disrupt the Course of Inflammatory Diseases
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. With the ability to replete gelsolin depleted by disease, BioAegis is in a unique position to deliver therapeutics that have the potential to disrupt the way many diseases are treated today.

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.

The white paper, Plasma Gelsolin to Protect Tissue/Organs in Severe Coronavirus Infection without Compromising Pathogen Response, outlining how rhu-pGSN supplementation would work in COVID-19, can be accessed by clicking here.

Investor Inquiries:
Steven Cordovano

Media Inquiries:
Christine Lagana

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.