February 2021: NIH and Other Independent Studies Confirm Low Levels of BioAegis’ ‘Inflammation Regulator Protein,’ Gelsolin, Associated with COVID-19 Severity

MORRISTOWN, N.J., Feb. 02, 2021 (GLOBE NEWSWIRE) — BioAegis Therapeutics Inc., a clinical stage, private company developing therapies for infectious, inflammatory and degenerative diseases through a portfolio built around gelsolin technology, announced today that studies from three independent groups of investigators, including the NIH, have reported that low levels of gelsolin are associated with severity and organ failure in COVID-19 patients, with the lowest pGSN levels seen in patients who subsequently died. BioAegis is currently conducting a Phase 2 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.

The role of Inflammation in COVID-19 Long Haulers
In addition, BioAegis is exploring the potential role gelsolin may have in COVID-19 long-haulers — patients suffering from lingering symptoms after recovering from the virus. Gelsolin has been demonstrated to regulate the overexuberant inflammatory response without suppressing the body’s immune response in multiple experimental models.

NIH Identifies Gelsolin as a Biomarker to Predict COVID Severity
The study, An Immune-Based Biomarker Signature is Associated with Mortality in COVID-19 Patients, published in JCI Insight, analyzed 66 immune-based biomarkers and the association between each and the risk of mortality. Gelsolin was identified as associated with COVID-19 severity and death.

Notably, pGSN, a biomarker thought to curtail inflammation and platelet aggregation–associated coagulation whose low levels have been seen in patients with sepsis and have been associated with impaired lung function and death, was significantly decreased with increasing disease severity, with the lowest pGSN levels seen in patients who subsequently died.”

The publication is a result of a major initiative by The National Institute of Health (NIH) Clinical Center NIAID Strategic Plan for COVID-19 Research to understand the immune response during COVID-19 infection and convalescence.

Organ Failure Scores Associated with Low Gelsolin Levels
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 that pGSN 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.”

Protein Biomarkers Can Aid in Clinical Classification and Potential COVID-19 Therapeutics
A third independent 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 reported association 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 Supplementation is a Host-Based Approach to Regulate Inflammation
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/

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.

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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.