Wednesday, February 06, 2019 10:00:24 PM
BioVie Completes Patient Enrollment for its Phase 2a Clinical Trial of BIV201 in Refractory Ascites?
February 06, 2019 08:00 ET | Source: BioVie Inc.
LOS ANGELES, Feb. 06, 2019 (GLOBE NEWSWIRE) -- 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.
About BIV201
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.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause BioVie's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. BioVie has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are BioVie's need for, and the availability of, substantial capital in the future to fund its operations and research and development; and the risks that BioVie's compounds may experience delays or difficulties in commencing or completing clinical studies, may not successfully complete pre-clinical or clinical testing, or may not be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in BioVie's filings with the Securities and Exchange Commission under its former name. In addition to the risks described above and in BioVie's filings with the SEC, other unknown or unpredictable factors also could affect BioVie's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on any forward-looking statements. BioVie undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation. BioVie cannot guarantee the approval of patents or Orphan-drug applications, nor the completion or success of its clinical trials.
CONTACT INFORMATION
BioVie Inc.
info@biovieinc.com
Copyright © 2019 BioVie Inc, All rights reserved.
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