BEVERLY, MA, USA I November 29, 2016 I 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.
SOURCE: BioVie
Post Views: 183
BEVERLY, MA, USA I November 29, 2016 I 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.
SOURCE: BioVie
Post Views: 183
