July 17, 2017: Versantis, a pharmaceutical company reinventing the diagnosis, prevention, and treatment of patients with liver diseases, today announces that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to VS-01 for the treatment of patients with acute-on-chronic liver failure (ACLF). VS-01 is a proprietary liposomal fluid infused in the abdominal cavity where it enhances the elimination of ammonia and other toxic metabolites responsible of the poor prognosis in ACLF patients.
“ACLF is a recently recognized condition affecting patients with cirrhosis and rapidly progressing to encephalopathy, multi-organ failures, and fatalities. VS-01 is the first drug therapy to simultaneously support both liver and kidneys and promises to transform the lives of affected individuals and their families.” said Dr. Vincent Forster, CEO and co-founder of Versantis. “The granting of orphan drug designation in the U.S. is an important step forward in the development of VS-01 and highlights the high unmet medical need for new therapies in this indication. We are on track to file a clinical trial application in late 2018 and committed to bringing VS-01 to patients in a timely manner.” added Meriam Kabbaj, COO and co-founder of Versantis.