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Vasomune Therapeutics, Inc., and AnGes, Inc., Announce US FDA Clearance of Investigational New Drug (IND) Application For Pegevongitide (AV-001) Treatment in Resuscitation of Severely Burned Patients
TORONTO, March 04, 2026--FDA clears IND for Pegevongitide (AV-001), a Tie2 agonist targeting vascular leak, to evaluate acute resuscitation in severe burns.
About this update from Anges. Inc.
[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":400,"url":"https://media.zenfs.com/en/business-wire.com/39de536c15d079ff0eba820c892d3770"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/K2XYX04ZuQWJ7fwjYNpaOw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTcwNTtjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/39de536c15d079ff0eba820c892d3770","width":400,"height":400}},"lazy":false},{"type":"text","content":"TORONTO, March 04, 2026--(BUSINESS WIRE)--Vasomune Therapeutics, Inc., ("Vasomune"), a clinical-stage biopharmaceutical company, today announced U.S. Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application to develop Pegevongitide (AV-001) for use in the acute resuscitation of severely burned patients. Pegevongitide, an injectable Tie2 agonist that blocks vascular leak, is currently being researched for the prevention and treatment of acute respiratory distress syndrome (ARDS) (NCT05123755).","length":545,"tagName":"p"},{"type":"text","content":""Vascular leak reflects a loss of endothelial barrier integrity, thereby allowing fluid and proteins to escape the intravascular space into surrounding tissues. This disrupts oxygen delivery, organ perfusion, and destabilizes hemodynamics. By activating the pivotal target Tie2, Pegevongitide targets a root mechanism of endothelial instability and leakage," said Harold Kim, Ph.D., Vice-President of Research at Vasomune.","length":432,"tagName":"p"},{"type":"text","content":""In severely burned patients, vascular leak allows large volumes of fluid, proteins, and inflammatory mediators to shift from the bloodstream into injured and uninjured tissues," said Dr. John C Kubasiak, Chief of Burn Surgery at Loyola University Medical Center in Chicago. "As a burn surgeon, I witness the impact of vascular leak driving profound edema, shock, impaired oxygen delivery, and multi-organ dysfunction."","length":439,"tagName":"p"},{"type":"text","content":"This new IND clearance allows Vasomune to initiate a clinical program evaluating Pegevongitide safety and efficacy in the resuscitation of severely burned patients. Pegevongitide offers a promising new approach by targeting the Tie2/Angiopoietin-1 signaling pathway to stabilize b...