BioVie’s Liver Disease Treatment Meets Safety and Tolerability Endpoints
BioVie Inc. (NASDAQ: BIVI) has announced 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 company presented the data at The American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting 2023 this week.
Cuong Do, BioVie’s President and Chief Executive Officer, said, “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. Currently, the only options for these patients are transjugular intrahepatic portosystemic shunt (TIPS) surgery or liver transplantation, which are invasive and come with numerous potential life-altering complications.”
BioVie expects to accelerate BIV201 into Phase 3 trials in Q2 2024.
Highlights
Results of BioVie’s Phase 2 study showed that BIV201 in combination with SOC was well tolerated and had a favorable safety profile.
BIV201 is administered using the Company’s patent-pending liquid formulation of terlipressin in a prefilled syringe format as a continuous low dose infusion with a portable pump.
BIV201, a continuous infusion of terlipressin, received Orphan Drug Designation for treatment of ascites from the U.S. Food and Drug Administration in 2017.
Terlipressin is currently used in over 40 countries to treat related complications of liver cirrhosis, though is not available in the U.S. or Japan.
Ascites is a common complication of advanced liver cirrhosis in which large volumes of fluid accumulate in the abdomen due to liver and kidney dysfunction. Patients that progress to refractory ascites face a one-year survival rate of approximately 50%.
About BioVie
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease. For more information, visit http://www.bioviepharma.com/.
