Partnership supports execution of a large phase 2 global study to evaluate efficacy and safety of recombinant human plasma gelsolin (rhu-pGSN) for moderate-to-severe ARDS.

NORTH BRUNSWICK, NJ, USA I October 16, 2023 I BioAegis Therapeutics, a pioneering biotech company at the forefront of innovative therapies for inflammatory diseases, is pleased to announce a second partnership with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. This partnership comes with the award of a $20 million contract from BARDA’s Division of Research, Innovation, and Ventures (DRIVe), to advance gelsolin, a master regulator of the innate immune system, for the treatment of Acute Respiratory Distress Syndrome (ARDS). This significant injection of funding accelerates BioAegis’ ARDS program and the execution of its strategy to transform the treatment of inflammatory diseases.

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

Acute Respiratory Distress Syndrome (ARDS) is a condition that can develop as a severe complication of pneumonia, sepsis, or trauma 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 US 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.

“We are delighted that BARDA DRIVe has chosen to continue our partnership with this shared goal of addressing the challenges of ARDS by bringing plasma gelsolin therapy to patients,” 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 (BARDA), 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.

SOURCE: BioAegis