Gelsolin immunomodulator treatment associated with patient’s rapid recovery.
NORTH BRUNSWICK, N.J., Aug. 27, 2021 (GLOBE NEWSWIRE) — BioAegis Therapeutics Inc., a clinical stage, private company developing therapies for infectious, inflammatory, and degenerative diseases based on a portfolio built around gelsolin technology, announced that a case study, Recombinant Human Plasma Gelsolin (rhu-pGSN) in a Patient Hospitalized with Critical COVID-19 Pneumonia, was published in Clinical Infection in Practice.
This compassionate-use case paper is intended to introduce clinicians to BioAegis’ novel host-based therapeutic, rhu-pGSN, under development for critical COVID-19 pneumonia as well as for other serious infectious and noninfectious diseases.
Critical Hospitalized Intubated COVID-19 Patient Receives Gelsolin Treatment
The patient is a 73 year-old, non-obese, active woman in generally good health. On her fifth day of hospitalization for COVID, she was intubated and sedated for worsening respiratory distress. The patient became hypotensive, requiring pressors to keep her blood pressure up for 36 hours. Subsequently the patient was then given three doses of rhu-pGSN over 36 hours. No infusion reactions or adverse events were recognized. Her blood pressure remained stable without vasopressor support. She noticeably improved while receiving rhu-pGSN. Her recovery continued after completion of the course of rhu-pGSN. On day five after gelsolin treatment, she was extubated and antibiotics were discontinued.
Study co-author and BioAegis’ Chief Medical Officer, Dr. Mark DiNubile, remarked,
“While a single case study does not prove efficacy of our treatment, it was gratifying to observe a rapid and complete recovery of a patient with critical COVID pneumonia. The maximum benefit of immunotherapies, like gelsolin, appears to be in the sickest patients where there is an overexuberant inflammatory response.”
Gelsolin, “The Master Regulator of Inflammation”, Disrupts the Course of Infectious & Inflammatory Diseases
The inflammatory response is essential to the healing process and to fight infection. The damage inflicted by COVID-19 is primarily mediated through an overly exuberant host response to the virus, not directly by the virus itself. This overblown reaction consists of excessive and prolonged inflammation leading to a harmful cytokine storm.
Gelsolin regulates inflammation without suppressing immune function. Gelsolin’s unique role is to modulate this necessary inflammatory response so that what was intended to be a mechanism of healing does not become an instrument of long-term morbidity or death. In extreme circumstances like those present in COVID-19, gelsolin can become dangerously depleted, leaving the body exposed to the ravages of an unrestrained immune response.
BioAegis’ approach is simply to supplement this naturally occurring human protein which we have produced with a recombinant manufacturing process. This approach has been successful in over 20 animal models, indicating direct evidence of protection of the lungs. The Company recently completed a safety study in hospitalized pneumonia patients.
BioAegis is currently evaluating data from our Phase 2 clinical study of recombinant human plasma gelsolin (rhu-pGSN) added to standard of care for treatment of patients with severe COVID-19 pneumonia. Primary outcome measures will evaluate efficacy and safety. Specific details of the protocol can be reviewed at: https://clinicaltrials.gov/ct2/show/NCT04358406
This human protein enhances the body’s ability to manage excess inflammation without suppressing immune function, unlike currently approved anti-inflammatory treatments.
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’ platform is built upon the recombinant form of plasma gelsolin, a highly conserved abundant human protein in healthy individuals. Its role is to keep inflammation localized to the site of injury and to boost the body’s ability to clear pathogens, but normal levels are depleted by diverse inflammatory conditions. Restoring gelsolin levels with the human recombinant form helps immune cells fight infection and controls inflammation so it does not spread and cause damage.
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 will also have US biologics exclusivity and has recently filed new IP in areas of unmet need.
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.