BioAegis Therapeutics Announces FDA Clearance of IND for its Inflammation Regulator Protein for the Treatment of ARDS

BioAegis Therapeutics, Inc. recently announced the US FDA has approved its Investigational New Drug (IND) application for recombinant plasma gelsolin to proceed for the treatment of acute respiratory distress syndrome (ARDS).

ARDS is a serious inflammatory condition for which there are severe consequences with no current therapies other than supportive care. Its genesis can be from various etiologies, with severe infection being a frequent cause. It is estimated that in the US alone, ARDS affects over 700,000 patients per year or roughly 10% of all ICU admissions and these patients exhibit a mortality rate of ~40%. This mortality as well as damage to organs such as the lung is driven by excess inflammation.

BioAegis is collaborating with the BARDA DRIVe Solving Sepsis program, to further develop plasma gelsolin for ARDS. BARDA is a division of the US National Institutes of Health and ASPR (Administration for Strategic Preparedness and Response).

Plasma gelsolin (pGSN) is a naturally occurring human protein that is an important component of the innate immune system. As a master regulator of inflammation, its role is to keep inflammation localized to the site of injury and to boost the body’s ability to clear pathogens. Gelsolin can protect organ systems by quelling a potentially over-exuberant inflammatory response and subsequent immune dysregulation by preventing the systemic release of inflammatory mediators.

Plasma gelsolin is critically depleted in ARDS patients and has been shown to address both injurious and infectious inflammation in multiple studies. Treating patients with recombinant human plasma gelsolin (rhu-pGSN) holds much promise for addressing the over exuberant inflammatory response that can lead to ARDS and the subsequent high mortality levels associated with this condition without inducing global immunosuppression.

BioAegis is developing rhu-pGSN as an adjunct to standard-of-care measures, to prevent death and the progression of respiratory failure in subjects with serious infections who go on to develop acute lung injury/acute respiratory distress syndrome (ALI/ARDS). A Phase 2 clinical trial of rhu-pGSN is being planned for 2023.

Susan Levinson, PhD, Chief Executive Officer of BioAegis, said “Our innovative approach to addressing this high mortality condition addresses both the dysregulated inflammatory process and the need to enhance the immune response to infection.”

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, but normal levels 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 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.