Small NJ Biotech Firm, BioAegis Therapeutics, Accelerating Multiple Clinical Trial Submissions for Severe COVID-19 Pneumonia Patients

MORRISTOWN, N.J., April 02, 2020 (GLOBE NEWSWIRE) -- BioAegis Therapeutics Inc. is a clinical stage, private company focused on developing therapies for infectious, inflammatory, and degenerative diseases. Building upon intellectual property licensed from Harvard Medical School, BioAegis believes that its lead product, recombinant human plasma gelsolin therapy (rhu-pGSN), should be considered as a viable therapeutic option for patients suffering from severe lung injury due to COVID-19 and is submitting requests to the FDA and other international regulatory authorities to accelerate their clinical trial.

Capitalizing on Evolutionary Wisdom with A Naturally Occurring Human Protein

Plasma gelsolin (pGSN) is an ancient, highly conserved human protein that is abundant in healthy individuals. It is a master regulator of the immune system. Plasma gelsolin addresses the inflammatory component of infection without suppressing the immune system. In the case of a 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.

According to Mark DiNubile, MD, Chief Medical Officer, “What we've found is that if one just follows patients when they get to the emergency room after a major trauma, they have very low gelsolin levels and develop complications hours to days later, including ARDS and many of the complications we see in COVID-19. There is a period of hours to a few days from when the gelsolin is depleted to when the lung damage tends to occur. Hence, there is a window of therapeutic opportunity. Giving gelsolin back can replete a naturally occurring protein and possibly stem the tide.”

Plasma Gelsolin Reduces Severe Lung Injury, as Seen in COVID-19 Patients

BioAegis’ product, recombinant human plasma gelsolin (rhu-pGSN), disrupts the course of inflammatory and infectious diseases which very often can lead to long term morbidity or death. Supplementation with rhu-pGSN as an adjunct to standard-of-care measures has the potential to prevent or limit organ injury (and death) in patients with severe coronavirus infections. This strategy, rather than being a narrowly targeted pharmaceutical intervention, involves replenishing an already existing component of the immune system.

Plasma gelsolin has been tested in over 20 animal studies, as well as a recent phase 1b/2a study in hospitalized community-acquired pneumonia patients with no adverse safety signals. Recent scientific data on the influenza virus indicates that plasma gelsolin supplementation can prevent or reduce injury to the lung after severe lung infection. BioAegis is preparing to evaluate plasma gelsolin replacement in severe infection, specifically severe community-acquired pneumonia (sCAP), including COVID-19, and have engaged leading infectious disease experts to advise the proof of concept clinical trial strategy.

It is reasonable to believe that plasma gelsolin could have broad application to COVID-19 and other lethal respiratory illnesses. Plasma gelsolin is pathogen-indifferent—having been shown to be effective against gram positive and gram negative bacteria as well as influenza infection. BioAegis expects the mechanism of action would extend to other causes of pneumonia such as COVID-19. This is a key advantage, as an immediate solution for fighting future emerging infectious pathogens, for which vaccines, antibiotics and antivirals have not yet been developed.

Gelsolin Therapy is an Attractive Option for Critical Care Pneumonia Patients

Supplementing depleted systemic levels of plasma gelsolin has enormous potential to prevent debilitating and potentially lethal ravages of inflammation, without compromising its essential function to fight infection and promote repair. Its unique qualities are:

• Host-based, not pathogen specific. Recent findings demonstrate plasma gelsolin’s ability to treat both viral and bacterial infections, even those resistant to antibiotics.
• Naturally occurring human protein. Plasma gelsolin is part of our innate immune system and our body’s first line of defense against pathogens.
• Controls excess inflammation without suppressing the immune response to threats.
• Benign safety profile in studies to date. 
• High yield manufacturing. Highly productive and efficient processes have been developed for this recombinant protein.

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

For further information:
Steven Cordovano, 203-952-6373
Email:  [email protected]
www.bioaegistx.com

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.