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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
Data Show that BIV201 in Combination with Standard of Care (SOC) is Well Tolerated with No Major Difference in Treatment-Emergent Adverse Events (TEAEs)
About this update from Biovie Inc.
[{"type":"text","content":"Data Show that BIV201 in Combination with Standard of Care (SOC) is Well Tolerated with No Major Difference in Treatment-Emergent Adverse Events (TEAEs) Compared to SOC Alone With a ~50% Mortality Rate for Refractory Patients1, Efficacy and Safety Findings from the Phase 2b Trial Support Acceleration of BIV201 into Confirmatory Trials Company Reaffirms Commitment to Commencing Phase 3 Trial in Q2 2024 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. “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 (TIPS) 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.” Results showed that BIV201 in combination with SOC was well tolerated and had a favorable safety profile. 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 gra...