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.