Intercept Pharmaceuticals (ICPT)

[Trend-Setter]

BioVie Achieves Primary Objectives in Phase 2a Clinical Trial of BIV201 in Refractory Ascites

LOS ANGELES, April 30, 2019 (GLOBE NEWSWIRE) — BioVie Inc. (OTCQB: BIVI) (“BioVie” or “Company”), a clinical-stage company developing innovative drug therapies for liver disease, today announced top-line results for its Phase 2a clinical trial of BIV201 (continuous infusion terlipressin) in six patients with refractory ascites due to advanced liver cirrhosis. The primary objectives of this initial open-label study were to assess the safety, tolerability, and steady state pharmacokinetics (PK) of terlipressin administered as a continuous infusion for 28 days to cirrhotic patients with refractory ascites.

Exploratory objectives were to assess the reduction in requirement of frequency and volume of paracentesis with continuous infusion of terlipressin.

The following results were observed:

Continuous infusion of terlipressin via portable infusion pump was maintained for 28 days in three patients with refractory ascites, and all patients remained hemodynamically stable during treatment.
The steady state plasma concentration data characterized terlipressin pharmacokinetics (PK) within the predicted PK model concentrations.
Four of the six patients treated with BIV201 experienced an increase in the number of days between paracenteses ranging from 71% to 414% compared to prior to initiating therapy.
BioVie is planning to share detailed study results with the FDA in a meeting scheduled for the first half of 2019. At that time, the Company expects to receive guidance for planning the next steps in the BIV201 clinical development plan.

“The primary study objectives were met,” stated Patrick Yeramian MD, BioVie Chief Medical Officer. “These initial findings will need to be confirmed in a larger clinical trial that is randomized and controlled.”

https://www.otcmarkets.com/stock/BIVI/news/BioVie-Achieves-Primary-Objectives-in-Phase-2a-Clinical-Trial-of-BIV201-in-Refractory-Ascites?id=226394