BioAegis Therapeutics Unveils Upcoming Clinical Study of Gelsolin, an Immune Regulator, as a Treatment for Patients with Acute Respiratory Distress Syndrome (ARDS)

Phase 2
Feb. 27, 2024 -- BioAegis Therapeutics, a pioneering biotech company at the forefront of innovative therapies for inflammatory diseases, is pleased to announce site recruitment for BTI-203, a Phase 2 study of recombinant human gelsolin (rhu-pGSN) for the treatment of Acute Respiratory Distress Syndrome (ARDS) (NCT05947955).
The study, A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Recombinant Human Plasma Gelsolin With Standard of Care for Moderate-to-Severe ARDS Due to Pneumonia or Other Infections is being conducted under a contract with BARDA’s Division of Research, Innovation, and Ventures (DRIVe), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services.
Approximately 80 sites in the US, Canada, UK and the EU, including Belgium, France, Italy, Germany, Netherlands, Spain and others will conduct the study. Enrollment is targeted for 600 subjects. The planned primary outcomes are all-cause mortality at Day 28 between treatment groups and incidence, causality, and severity of SAEs in rhu-pGSN vs placebo treatment.

Effectively Treating ARDS will Reduce Society’s Vulnerability to Global Pandemics

ARDS is a condition that can develop as a severe complication of sepsis, trauma, pneumonia or other infectious diseases, resulting in life-threatening lung injury with fluid leakage into the lungs. Breathing becomes difficult and patients require oxygen, mechanical ventilation and extensive critical care resources, placing a significant burden on the healthcare system.
Even with aggressive medical management, a substantial number of patients do not survive, and those who do may suffer from long-term complications, including impaired lung function and reduced quality of life. In the U.S. alone, ARDS affects over 700,000 patients per year or roughly 10% of all ICU admissions. The mortality rate for ARDS is approximately 40%. The lack of effective therapies to treat ARDS and its associated high mortality driven by excess inflammation underscores the urgent need for an innovative therapy in this field.

Plasma Gelsolin: A Multitasking Protein for a Complex Condition

Plasma gelsolin holds immense promise as a therapeutic intervention for ARDS due to its multifaceted mechanism of action. Gelsolin has demonstrated the ability to:
Modulate the activation of the NLRP3 inflammasome and generation of IL-1β-containing microparticles
Facilitate uptake and killing of microbial pathogens by innate immune cells
Bind to and remove harmful inflammatory mediators
Regulate macrophage phenotype to modulate inflammation
Gelsolin is a naturally occurring human protein found in the bloodstream, which is depleted by counteracting the inflammatory process. Supplementation with the recombinant gelsolin protein holds promise to address the overzealous inflammatory response associated with ARDS.
"ARDS is significant source of mortality as well as a drain on healthcare resources across the globe. We are committed to reaching our goal of saving lives by addressing the challenges of this complex disease," stated Susan Levinson, Ph.D., Chief Executive Officer of BioAegis.
This project has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50123C00067.

About BioAegis

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, plasma 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. Normal levels of pGSN are depleted by diverse inflammatory conditions. Restoring gelsolin levels with the human recombinant form, rhu-pGSN, helps immune cells fight infection and controls inflammation so it does not spread and cause organ damage. Rhu-pGSN is a non-antibiotic, host-directed, non-immunosuppressive treatment for inflammation due to both infectious and non-infectious causes.
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 inflammatory disease, infection, renal failure, and neurologic disease. BioAegis will also have US biologics exclusivity and has recently filed new IP in areas of unmet need.
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