BioVie Inc. announced that the first patient has been enrolled in the Company’s Phase 2b trial of BIV201 (continuous infusion terlipressin) for the treatment of refractory ascites. The trial—A Study for Evaluation of BIV201 to Reduce Ascites and Complications in Patients with Cirrhosis and Refractory Ascites—is being conducted at nine prestigious research centers in the U.S. (NCT04112199). Two additional patients have consented to the pre-randomization observation period, and 7 more potential participants have been identified through pre-screening. Ascites is a common complication of advanced liver cirrhosis involving the accumulation of large volumes of fluid in the abdomen, often exceeding 5 liters, due to liver and kidney dysfunction. An estimated 20,000 Americans suffer from refractory ascites, which means that their ascites no longer responds to off-label diuretic therapy or they cannot tolerate these drugs. The FDA has never approved a drug for treating ascites, and once patients reach the refractory stage the estimated one-year survival rate is only approximately 50% (Bureau et al. 2017). BIV201 is a continuous infusion of terlipressin, a drug used in over 40 countries to treat related complications of liver cirrhosis that is not available in the US or Japan. The Phase 2b trial is evaluating the efficacy of BIV201, which has an Orphan drug designation, in addition to SOC compared to SOC alone for the treatment of refractory ascites in the home care setting. BIV201 is being 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 in two 28-day treatment cycles. 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). If the results are positive, the Company plans to conduct a pivotal Phase 3 trial commencing in 2022. BioVie previously conducted a Phase 2a trial of BIV201 in a similar patient population at a Veterans Administration hospital. The pharmacokinetics (PK) of terlipressin following continuous infusion generated in this study determined for the first time that administration of terlipressin as a low dose continuous infusion avoids high, potentially harmful, peak blood concentrations associated with intermittent IV bolus dosing. The study also found that the drug was overall well tolerated and that it was feasible to administer terlipressin by continuous infusion in an outpatient setting. BioVie recently announced FDA guidance for the design of an additional pivotal Phase 3 study of BIV201 in the treatment of hepatorenal syndrome-acute kidney injury (HRS-AKI), which the Company plans to begin next year. BIV201 has an Orphan drug designation covering this condition which is a severe complication of ascites with a mortality rate of approximately 50% over 2-4 weeks if left untreated.