TORONTO–(BUSINESS WIRE)–#ARDS–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).
โVascular 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,โ said Harold Kim, Ph.D., Vice-President of Research at Vasomune.
โIn severely burned patients, vascular leak allows large volumes of fluid, proteins, and inflammatory mediators to shift from the bloodstream into injured and uninjured tissues,โ said Dr. John C Kubasiak, Chief of Burn Surgery at Loyola University Medical Center in Chicago. โAs a burn surgeon, I witness the impact of vascular leak driving profound edema, shock, impaired oxygen delivery, and multi-organ dysfunction.โ
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 blood vessels, prevent vascular leakage and reduce vascular inflammation. Published preclinical data using Pegevongitide supports that this mechanism can reduce vascular leak and improve hemodynamic function.
Dr. Ei Yamada, President & CEO of AnGes, said that โWe are encouraged by the FDA decision to allow the expansion of our AV-001 development program. Our commitment to developing AV-001 will allow us to take a step forward in the treatment of serious pathologies driven by vascular leak.โ
About Vasomune Therapeutics, Inc.
Vasomune Therapeutics, Inc. is a private clinical-stage biopharmaceutical company developing the next generation of medicines to boost the bodyโs ability to defend against vascular leak. Founded in 2014, Vasomune has focused on vascular normalization strategies, and has progressed the lead candidate Pegevongitide (AV-001) from bench to bedside. Vascular dysfunction and vascular leak are associated with the pathology of several disease states, including bacterial and viral pneumonia and acute respiratory distress syndrome, sepsis, hemorrhagic shock, acute kidney injury, stroke, and vascular dementia. Vasomuneโs corporate headquarters and laboratories are in Toronto, Canada with US offices in Raleigh, NC. For more information about the company please visit http://www.vasomune.com.
About AnGes, Inc.
AnGes, Inc., a biopharmaceutical company founded in December 1999, focuses on the development of gene-based medicines. The company’s flagship development product and genetic drug, HGF gene therapy products, received Breakthrough Therapy designation from the FDA in 2024. AnGes is currently working on the development of a Tie2 tyrosine kinase receptor agonist (AV-001) for viral and bacterial-associated pneumonia and an NF-ฮบB decoy oligonucleotide for chronic discogenic lumbar back pain. Furthermore, AnGes acquired EmendoBio in December 2020 to expand its capabilities in genome-editing technologies. For more information, visit https://www.anges.co.jp/en/.
Contacts
Shahid Ahmad, Vice-President Operations and Planning
Vasomune Media Relations
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