Research & Development
BioVie reports positive efficacy data from Phase 2b ascites study
13 March 2023 -

Clinical-stage biotechnology company BioVie Inc (NASDAQ:BIVI) announced on Monday that it has paused patient enrolment in its Phase 2b ascites clinical trial after seeing "encouraging" data from the first 15 patients.

The trial is evaluating BIV201 (continuous infusion terlipressin) for the treatment of refractory ascites.

In the study so far, treatment with BIV201 plus standard of care (SOC) resulted in a 34% reduction in ascites fluid during the 28 days after treatment initiation compared to the 28 days prior to treatment. By comparison, those treated with SOC only experienced a mean increase in ascites fluid of 3.1%. Patients who completed the treatment with BIV201 experienced a 53% reduction in ascites fluid and this improvement was sustained during the three months after treatment initiation.

Ascites is a common complication of advanced liver cirrhosis involving the accumulation of large volumes of fluid in the abdomen, due to liver and kidney dysfunction. There are currently no drugs approved by the US Food and Drug Administration (FDA) to treat ascites, and once patients reach the refractory stage the estimated one-year survival rate is only approximately 50%.

Cuong Do, BioVie's president and CEO, said: "Given the high unmet need for this condition, we believe the most prudent course is to initiate conversations with the FDA on proceeding to the pivotal Phase 3 trial so that we can bring this innovation to patients as quickly as possible."