BioVie Inc. provided a general update on the progress of its mid-stage (Phase 2a) clinical trial of BIV201 in refractory ascites patients. To date, two refractory ascites patients have been treated in the Phase 2a open-label clinical trial of BIV201 of the 6 total patients to be enrolled. While no conclusions can be drawn from only two subjects, both patients indicated evidence of response on certain efficacy measures. Refractory ascites patients are extremely ill with a very poor quality of life. They have frequent hospitalizations due to disease complications and a mortality rate of approximately 50% at 6 to 12 months. Both patients in the BIV201 trial experienced medical complications, but the drug itself (continuous infusion terlipressin) was well tolerated. After reviewing the results, the Data and Safety Monitoring Board (DSMB) supported continuing the clinical study. The results for all 6 refractory ascites patients planned for BioVie's Phase 2a clinical trial of BIV201 are expected by the second quarter of 2018. In addition to evaluating the safety of BIV201 therapy, the study will examine indicators of efficacy, including reduction in ascites fluid volume and the need for paracentesis procedures (the mechanical withdrawal of large amounts of ascites fluid by large bore needle). The study will also evaluate the steady-state pharmacokinetics (PK) of terlipressin and its active metabolite. The company's new drug candidate, BIV201, has Orphan-drug designation and US patent protection, and represents a potential new treatment for thousands of patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis caused by hepatitis, NASH, and alcoholism. The initial disease target for BIV201 therapy is ascites, which is the most common serious complication of advanced liver cirrhosis. The FDA has never approved a drug specifically indicated for the treatment of ascites. The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis, but is not available in the US or Japan. BioVie has applied for additional Orphan-drug designations for other life-threatening conditions associated with advanced liver cirrhosis.