BioVie announces ‘positive’ clinical safety data from study of BIV201

BioVie announced “positive” clinical safety data from the company’s Phase 2b open-label study evaluating the efficacy and safety of BIV201, terlipressin administered as a continuous infusion, with standard of care in patients with refractory ascites due to cirrhosis. The data will be highlighted today in a late-breaking poster presentation titled “Safety and Tolerability of Continuous Infusion Terlipressin In Patients with Decompensated Cirrhosis and Refractory Ascites: A Phase 2, Randomized, Controlled, Open-Label Study” at The American Association for the Study of Liver Diseases – AASLD – The Liver Meeting 2023 in Boston, MA. “Our Phase 2b results mark a significant step toward providing a treatment for cirrhosis patients with refractory ascites, of whom face a survival rate as low as 50% within a year of diagnosis.1 Currently, the only options for these patients are transjugular intrahepatic portosystemic shunt surgery or liver transplantation, which are invasive and come with numerous potential life-altering complications,” said Cuong Do, BioVie’s President and Chief Executive Officer. “These data being presented, coupled with statistically significant efficacy, allowed BioVie to halt the trial prior to completion and further strengthen our confidence in accelerating BIV201’s development into Phase 3 trials, which we expect to initiate in Q2 2024.”