BioVie Achieves Primary Objectives in Phase 2a Clinical Trial of BIV201 in Refractory Ascites
- Category: Proteins and Peptides
- Published on Tuesday, 30 April 2019 17:00
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LOS ANGELES, CA, USA I April 30, 2019 I 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.”
BIV201 (continuous infusion terlipressin) is being investigated as a potential new therapy for patients suffering from ascites, hepatorenal syndrome (HRS), and other life-threatening complications of advanced liver cirrhosis caused by hepatitis, nonalcoholic steatohepatitis (NASH), and alcoholism. The initial disease target for BIV201 therapy is ascites, which is a serious complication of advanced liver cirrhosis. The FDA has never approved any drug specifically for treating 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. BIV201 has received Orphan Drug designations for the treatment of ascites and for HRS, has FDA Fast Track status, and US patent protection. For more information about BioVie, please visit our website: www.biovieinc.com.
About Liver Cirrhosis, Ascites, and Hepatorenal Syndrome
Chronic liver cirrhosis and its complications are the eighth leading cause of death in the US (Runyon 2013). Patients with cirrhosis and ascites account for an estimated 116,000 US hospital discharges annually with frequent early readmissions. Those requiring paracentesis (physical removal of ascites fluid) experience an average hospital stay lasting 8 days and generate approximately $5 billion in medical costs (HCUP Nationwide Readmissions Database 2016). Cirrhosis results primarily from hepatitis, alcoholism, and nonalcoholic steatohepatitis (NASH) linked to fatty liver disease and obesity. Ascites is the most common serious complication of advanced liver cirrhosis. Certain drugs approved for other uses may provide initial relief, but patients often fail to respond to them as the ascites worsens. At this stage, known as refractory ascites, patients often progress to hepatorenal syndrome (HRS) which is the onset of kidney failure and requires emergency hospitalization. No medications have been approved by the FDA specifically for the treatment of ascites, and an estimated 40% of patients die within two years of diagnosis. Nor have any drug therapies been approved specifically for treating HRS, and about one-half of these patients will succumb within only 2 – 4 weeks.