On May 21, 2020, BioAegis Therapeutics announced that the National Institute of Health Clinical Center began 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 was a critical step in a large international collaborative to understand the immune response during COVID-19 infection and convalescence.

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.”

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.