SOURCE: BioVie Inc.

BioVie Inc (Ticker Symbol: BIVI)

September 14, 2017 08:00 ET

First Patent Enrolled in BioVie Phase 2a Clinical Trial of BIV201 for Ascites

BEVERLY, MA--(Marketwired - September 14, 2017) - BioVie Inc. (OTCQB: BIVI), a clinical-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, today confirmed enrollment of the first patient in the Company's mid-stage (Phase 2a) clinical trial of BIV201 for the treatment of patients with refractory ascites due to liver cirrhosis. The initial trial is being led by Jasmohan Bajaj, MD, MS, study site principal investigator (PI) at the McGuire Research Institute in Richmond, VA.

The study titled Safety and pharmacodynamic activity of low-dose terlipressin delivered by continuous intravenous infusion in patients with cirrhosis and refractory ascites requiring recurrent large volume paracentesis is an open-label prospective study in a cohort of 6 patients who are refractory to, or intolerant of, diuretic therapy. In addition to examining the safety of BIV201 therapy, the trial will evaluate the steady-state pharmacokinetics (PK) of terlipressin's active metabolites and explore reduction in paracentesis procedures and ascites fluid generation as secondary outcome measures. More information about the trial may be found at clinicaltrials.gov, identifier: NCT03107091.

"Enrolling our first patient represents a major step in the BIV201 clinical development program," commented Jonathan Adams, BioVie CEO. "We are grateful for the hard work by Dr. Bajaj, our expert medical advisors, and our clinical team to enable this accomplishment."

About BioVie Inc.

BioVie Inc. is a clinical-stage company pursuing the discovery, development, and commercialization of innovative drug therapies. The Company is currently focused on developing and commercializing BIV201, a novel approach to the treatment of ascites due to chronic liver cirrhosis. 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. For more information about BioVie, please visit our website: www.biovieinc.com.

About BIV201

The Company's lead drug candidate BIV201 has the potential to improve the health of thousands of patients suffering from life-threatening complications of liver cirrhosis due to hepatitis, NASH, and alcoholism. It has Orphan-drug designation and US patent protection for the most common of these complications, ascites, which represents a significant unmet medical need. The FDA has never approved any drug specifically for treating ascites. BioVie has applied for additional Orphan-drug designations for related diseases.

About Liver Cirrhosis and Ascites

More than 600,000 Americans and millions worldwide suffer from liver cirrhosis. Cirrhosis is the 12th-leading cause of death due to disease in the US, killing an estimated 30,000 people each year. The condition results primarily from hepatitis, alcoholism, and nonalcoholic steatohepatitis (NASH) linked to fatty liver disease and obesity. Ascites is a common complication of advanced liver cirrhosis. With no medications approved by the FDA specifically for treating ascites, an estimated 40% of patients die within two years of diagnosis. Certain drugs approved for other uses may provide initial relief, but patients often fail to respond to them as ascites worsens. In addition to patient suffering, US treatment costs for liver cirrhosis, including ascites and other complications, are estimated at more than $4 billion annually.

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 issuance of patents on its applications in foreign counties nor the completion or success of its planned Phase 2a clinical trial.

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