BioVie Completes Patient Enrollment for its Phase 2a Clinical Trial of BIV201 in Refractory Ascites
- Category: Proteins and Peptides
- Published on Wednesday, 06 February 2019 17:07
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LOS ANGELES, CA, USA I February 06, 2019 I BioVie Inc. (OTCQB: BIVI) (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for liver disease, announced today that it has completed enrollment in a Phase 2a open-label clinical study of BIV201 (continuous infusion terlipressin) in patients with refractory ascites due to advanced liver cirrhosis. The Company’s novel drug candidate BIV201 has Orphan drug designations for both ascites and hepatorenal syndrome (HRS), FDA Fast Track status, and US patent protection.
“We are pleased to have achieved this important clinical milestone as we continue to develop BIV201 for patients with refractory ascites who are at high risk of deadly complications,” stated BioVie Chief Medical Officer Patrick Yeramian, MD. “What we have learned from this initial study is informing our next clinical trial design. The results will be presented to the FDA in the first half of 2019 and we expect to receive guidance on the BIV201 clinical development plan.”
This mid-stage (Phase 2a) study was designed to assess the safety and tolerability of continuous infusion of terlipressin for 28 days in cirrhotic patients with refractory ascites, and to determine the pharmacokinetics of terlipressin and its active metabolites when administered by continuous low-dose infusion in these patients. Additionally, the trial assessed reduction in ascites fluid accumulation and improvement in renal function as potential indicators of efficacy with BIV201 treatment.
BIV201 (continuous infusion terlipressin) represents a potential new treatment option for patients suffering from ascites, 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. There are no approved drugs in the US 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. In addition to Orphan Drug designations for ascites and HRS, BIV201 has FDA Fast Track status and US patent protection. For more information about BioVie, please visit our website: www.biovieinc.com.