BEVERLY, MA--(Marketwired - September 22, 2016) - BioVie Inc. (OTC PINK: BIVI) (the "Company"), a development-stage company focused on the discovery, development, and commercialization of innovative drug therapies, announced that its scientific team has completed an assessment of the link between nonalcoholic steatohepatitis (NASH), chronic liver cirrhosis, and ascites. The Company's new drug therapy BIV201 targets ascites, a common complication of liver cirrhosis.
The number of Americans afflicted with NASH due to fatty liver disease has skyrocketed to an estimated 16 to 30 million due to the obesity epidemic. With no FDA-approved therapy to halt progression of the disease, there is a significant unmet medical need for the estimated 1.3 million who will progress to advanced liver cirrhosis and its complications. According to a 2015 study by Wong et al., NASH is now the second-leading cause of liver disease among US adults awaiting liver transplantation, and is expected to become the leading cause within ten years. Additionally, patients with liver cirrhosis due to NASH, who are on the liver transplant waiting list, appear to have the lowest probability of survival compared to those having cirrhosis due to other causes.
Serious medical complications often occur in patients with advanced liver cirrhosis, the most common being the development of ascites, or fluid accumulation in the abdomen, a major contributor to patient mortality. BioVie is developing BIV201 as a new drug candidate for ascites due to liver cirrhosis as a result of NASH and other causes. Currently no drugs are available with a specific FDA approval for treating ascites.
BioVie CEO Jonathan Adams commented: "We are seeing impressive therapeutic advances in NASH, which is very gratifying. But it's important to keep in mind the many patients who progress to advanced liver cirrhosis and suffer miserably as a result. The progression of liver cirrhosis should be viewed as a continuum, and effective therapeutic interventions are needed at every stage."
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 may fail to respond to treatment as ascites worsens. This unfavorable prognosis represents a critical unmet medical need. US treatment costs for liver cirrhosis, including ascites and other complications, are estimated at more than $4 billion annually.
About BioVie (formerly NanoAntibiotics)
BioVie Inc. is a development-stage company pursuing the discovery, development, and commercialization of innovative drug therapies. The Company is currently focused on commercializing BIV201, a novel approach to the treatment of ascites due to liver cirrhosis. In early 2016 the Company held a pre-investigational new drug ("pre-IND") meeting with the FDA, which provided guidance for an IND submission. The Company's new drug candidate could potentially commence a mid-stage (Phase 1b) US clinical trial in 2017.
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