Independent Studies Confirm Low Levels of Immune System Protein, Gelsolin, Associated With COVID-19 Severity

BioAegis Therapeutics Inc. recently announced that recent publications of independent studies have reported that low levels of gelsolin are associated with severe illness and organ failure in COVID-19 patients. BioAegis is currently conducting a clinical trial of recombinant human plasma gelsolin (rhu-pGSN) in severe COVID-19 patients to supplement gelsolin levels with the objective of preventing severe outcomes, such as organ failure and mortality. Gelsolin has been demonstrated to regulate the overexuberant inflammatory response without suppressing the body’s immune response in multiple experimental models.

According to Susan Levinson, PhD, CEO of BioAegis, “Previous studies in a wide range of inflammatory and injurious human conditions report plasma gelsolin depletion to be predictive of poor outcomes and associated with organ damage. These independent studies that confirm similar findings in COVID-19 support the hypothesis that rhu-pGSN supplementation in these patients could reduce morbidity and mortality. We are enrolling patients now in our Phase 2 trial to save lives in this devastating disease.”

In a study of 128 respiratory patients, Large-scale Multi-omic Analysis of COVID-19 Severity, which monitored thousands of diverse biomolecules from patients with and without COVID-19, gelsolin depletion was associated with poor outcomes. ICU patients had decreased gelsolin levels which correlated with the Sequential Organ Failure Assessment (SOFA) scores (p-value = 0.000045), a measure of the number and severity of organ dysfunction in six organ systems (respiratory, coagulation, liver, cardiovascular, renal, and neurologic). The authors commented “These data also indicate thatpGSN supplementation has excellent potential as a COVID-19 therapeutic. Indeed, pGSN is known to decrease in acute lung injury, and in animal models of lung injury repletion of pGSN has favorable effects.”

A second publication, Ultra-High-Throughput Clinical Proteomics Reveals Classifiers of COVID-19 Infection, evaluated 27 potential protein biomarkers in samples collected from a cohort of 31 hospitalized cases. The authors reportedassociation of gelsolin levels with severity of COVID-19 using the World Health Organization (WHO) scale of clinical status (p= 0.0017) and referenced gelsolin’s ability to modulate inflammation and protect lung tissue. They suggest, “The development of therapies to stabilize the gelsolin levels could hence be of direct therapeutic value for treating COVID-19.”

Gelsolin, a naturally occurring human protein that is abundant in healthy individuals, is a key component of the body’s innate immune system. 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. Supplementing depleted systemic levels of gelsolin with rhu-pGSN, has enormous potential to prevent debilitating and potentially lethal ravages of inflammation, without compromising its essential function to fight infection and promote repair. Rhu-pGSN is currently being evaluated as an adjunctive treatment, added to standard of care, for severe COVID-19 pneumonia patients, as part of BioAegis’ Phase 2 clinical trial of rhu-pGSN.  Details of the study can be found at: https://clinicaltrials.gov/ct2/show/NCT04358406

BioAegis Therapeutics Inc. is a NJ-based clinical stage, private company whose mission is to capitalize on a key component of the body’s innate immune system, gelsolin, to prevent adverse outcomes in diseases driven by inflammation and infection. BioAegis has the exclusive license to broad, worldwide intellectual property of gelsolin 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.