BioVie Submits Investigational New Drug Application for BIV201 for Treating Refractory Ascites due to Liver Cirrhosis
Anticipates Initiation of US Clinical Trial in 2017
BEVERLY, MA--(Marketwired - November 29, 2016) - BioVie Inc. (OTC PINK: BIVI), a development-stage company focused on the discovery, development and commercialization of innovative drug therapies in liver disease, today announced the submission of an Investigational New Drug (IND) application for new drug candidate BIV201 to the US Food and Drug Administration (FDA). BIV201 has the potential to become the first drug approved by the FDA to treat ascites due to chronic liver cirrhosis, a life-threatening medical condition.
"Filing the IND represents a major milestone for BioVie," commented CEO Jonathan Adams, "and is the culmination of many months of effort by our clinical development team. We are pleased to have completed this goal on schedule, and look forward to working with the FDA to advance BIV201 therapy." The IND also involved a substantial investment of resources in formulation testing and to develop a proprietary bioanalytical methodology. The active agent in BIV201 has been investigated in humans with complications of liver cirrhosis in more than 40 studies outside the US.
BIV201 is designed to target ascites at its mechanistic source and improve effective blood volume, thereby interrupting the process of ascites fluid generation. This novel therapeutic approach was granted Orphan Drug designation by the FDA in September. Ascites affects approximately 100,000 Americans. US treatment costs for liver cirrhosis, including ascites and other complications, are estimated at more than $4 billion annually.
Once notified by the FDA that the trial may proceed, BioVie plans to commence a mid-stage (Phase 1b) clinical trial in US ascites patients in 2017. For more information about BioVie and BIV201, please visit our website www.biovieinc.com.
About Liver Cirrhosis and Ascites
About one million 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 27,000 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.
About BioVie, Inc.
BioVie Inc. is a development-stage company pursuing the discovery, development and commercialization of innovative drug therapies focused in liver disease. The Company is currently focused on commercializing BIV201, a novel approach to the treatment of ascites due to liver cirrhosis. In late 2016 the Company submitted an investigational new drug (IND) application. After acceptance of the IND filing by the FDA, the Company's new drug candidate could potentially begin a mid-stage (Phase 1b) clinical trial in US patients in early 2017.
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 assure that the FDA will accept the BIV201 IND filing.