BioVie shared top-line results for its Phase 2a clinical trial of BIV201 in patients with refractory ascites due to advanced liver cirrhosis.
BioVie (OTCQB:BIVI) shared top-line results for its Phase 2a clinical trial of BIV201 in patients with refractory ascites due to advanced liver cirrhosis.
As quoted in the press release:
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.
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.”