BioVie Presents Positive Clinical Safety Data from Phase 2b Trial of BIV201 in Refractory Ascites at the American Association for the Study of Liver Disease (AASLD) - The Liver Meeting® 2023
CARSON CITY, Nev., Nov. 13, 2023 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”) a clinical-stage company developing innovative drug therapies for the treatment of advanced liver disease and neurological and neurodegenerative disorders, today 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 (SOC) 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 (BIV201) 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.
- The incidence of treatment emergent adverse events (TEAEs), including serious TEAEs, was similar in both treatment groups.
- Two patients who received BIV201 experienced hyponatremia that developed gradually, was asymptomatic, and was resolved upon discontinuation of the study drug.
- Primary endpoints were safety and tolerability, and incidence of certain complications (Grade ≥2) during the 180 days following randomization.
- BIV201, a continuous infusion of terlipressin, received Orphan Drug Designation for treatment of ascites from the U.S. Food and Drug Administration in 2017.