BioVie (OTCQB: BIVI), reviewed key milestones achieved over the past year and provided a general update on the progress of its mid-stage (Phase 2a) clinical trial of BIV201 in refractory ascites patients. As quoted from the press release: To date, two refractory ascites patients have been treated in the Phase 2a open-label clinical trial of …

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.

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