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BioAegis Therapeutics Announces FDA Clearance of IND for its 'Inflammation Regulator Protein,' Gelsolin, for the Treatment of ARDSNORTH BRUNSWICK, N.J., Jan. 26, 2023 (GLOBE NEWSWIRE) -- BioAegis Therapeutics, Inc., a clinical-stage company developing therapies for inflammatory diseases through a portfolio built around plasma gelsolin, a highly conserved and abundant endogenous human immune regulatory protein, announces that the U.S. Food and Drug Administration (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 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 Therapy Plasma gelsolin is critically depleted in ARDS patients and has been shown to address both injurious and infectious inflammation in multiple studies. 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, Ph.D., Chief Executive Officer of BioAegis stated, “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.” About BioAegis 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. Investor Inquiries: Media Inquiries: 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. |