BioVie Inc. 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 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.

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 gradually, was asymptomatic, and was resolved upon discontinuation of the study drug.

Cumulative safety data from the Phase 2a study (6 patients; 131 total days of BIV201 infusion) and Phase 2b study (10 patients; 379 total days of BIV201 infusion) further support the safety and tolerability in this population with only 1 serious adverse event related to terlipressin. Investigators concluded that the findings encourage further development and investigation of BIV201 in confirmatory trials for the treatment of diuretic-resistant ascites in patients with decompensated liver cirrhosis. The Phase 2b trial was a dose-titration, controlled study in which adult patients with cirrhosis and refractory ascites were randomized 2:1 to receive either BIV201 in addition to SOC, or SOC alone, during the intervention period, consisting of two 28-day treatment periods separated by a wash-out interval followed by a long-term follow-up period of 180 days.

Primary endpoints were safety and tolerability, and incidence of certain complications (Grade =2) during the 180 days following randomization. Ascites is a common complication of advanced liver cirrhosis in which large volumes of fluid accumulate in the abdomen (often exceeding 5 liters) due to liver and kidney dysfunction. Patients that progress to refractory ascites face a one-year survival rate of approximately 50%1. To date, there is no approved medical therapy specifically for refractory ascites.

Management of these patients is based upon procedures such as large-volume paracentesis and TIPS, which only provide temporary relief, lack disease-modifying effects, and lead to frequent life-threatening complications. 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.

BioVie plans to conduct a pivotal Phase 3 trial commencing in Second Quarter 2024. The poster will be presented, November 13 from 1:00 PM ? 2:00 PM.

In addition to the Phase 2 BIV201 data presented at The Liver Meeting® 2023, the company expects unblinded Phase 3 Alzheimer?s Disease (AD) data for its novel molecule, NE3107, in the late November/early December time frame. NE3107 selectively inhibits the inflammatory ERK signaling pathway that reduces neuroinflammation by inhibiting inflammation-driven insulin resistance and major pathological inflammatory cascades. Data pointing to the confluence of inflammation and insulin resistance in dementia is fueling an interest in developing therapies that target metabolic dysregulation in AD.

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. The primary endpoints are the incidence of serious disease-related complications and the change in cumulative ascites fluid volume in the BIV201 treated group (20 patients) versus the control group (10 patients).