BEVERLY, Mass., April 09, 2018 (GLOBE NEWSWIRE) -- BioVie Inc. (OTCQB:BIVI), a clinical-stage company focused on the development and commercialization of innovative drug therapies for liver disease, announced today that it has achieved 50% enrollment of the patients in its open-label Phase 2a clinical study of BIV201 (continuous infusion terlipressin) for treating refractory ascites due to advanced liver cirrhosis.
Penny Markham, PhD, BioVie Chief Scientist, stated, “The patients we are targeting for BIV201 therapy are desperately ill and experience a miserable quality of life. Absent liver transplantation, their outcomes are very poor. We are pleased to be working on developing a novel drug candidate that could potentially improve their future.”
BioVie is conducting a mid-stage (Phase 2a) clinical trial of its Orphan Drug candidate, BIV201 (continuous infusion terlipressin), which has FDA Fast Track status and US patent protection. This compound represents a potential new treatment for thousands of patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis caused by hepatitis, 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 a 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.
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 more than 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 the treatment of ascites, an estimated 40% of patients die within two years of initial 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 medical costs for liver cirrhosis, including ascites and other complications, are estimated at more than $4 billion annually.
About BioVie Inc.
BioVie Inc. is a clinical-stage company pursuing the development and commercialization of innovative drug therapies for liver disease. The Company is currently focused on developing and commercializing BIV201, a novel approach to the treatment of ascites due to chronic liver cirrhosis. For more information about BioVie, please visit our website: www.biovieinc.com. A company overview is available in Investors/Press Releases.
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