BioAegis Therapeutics Receives Approval to Proceed with Phase 2 Trial of its Gelsolin COVID-19 Treatment
MORRISTOWN, N.J., July 15, 2020 (GLOBE NEWSWIRE) -- BioAegis Therapeutics Inc., announces that it received regulatory clearance from The Spanish Agency for Medicines and Health Products (AEMPS) for its Phase 2 Proof of Concept study of its lead product, recombinant human plasma gelsolin (rhu-pGSN) in hospitalized patients with severe COVID-19 pneumonia. BioAegis expects to recruit its first patient and begin the study shortly at Hospital Universitari Sant Joan de Reus in Tarragona, Spain.
Clinical Protocol for Phase 2 Clinical Trial of rhu-pGSN
According to Susan Levinson, PhD, CEO of BioAegis, “Supplementing gelsolin levels has been successful in over 20 animal models. Our recently published study in viral pneumonia revealed direct genetic evidence that this promoted lung tissue repair and down-regulated the release of injurious cytokines. After recently completing a highly successful safety study in hospitalized pneumonia patients we are looking forward to improving outcomes in severely ill COVID-19 patients.”
Gelsolin is a Key Component of the Body’s Immune System
Dr. Mark DiNubile, Chief Medical Officer commented, “Harnessing the body’s immune system offers an innovative approach that may lead to more effective therapies for COVID-19 and other serious infectious and non-infectious inflammatory diseases.”
National Institutes of Health is Studying Gelsolin in COVID-19 Patients
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 has US biologics exclusivity and has recently filed new IP.
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.