SOURCE: BioVie

April 25, 2017 08:00 ET

BioVie Signs Cooperative Research and Development Agreement (CRADA) to Conduct a Phase 2a Clinical Trial of BIV201 in Refractory Ascites Patients

BEVERLY, MA--(Marketwired - April 25, 2017) - BioVie Inc. (OTCQB: BIVI), a clinical-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, today announced the signing of a Cooperative Research and Development Agreement (CRADA) to conduct a Phase 2a clinical trial of BIV201 in patients with refractory or intractable ascites due to advanced liver cirrhosis. The study is 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."

BIV201 is a continuous infusion of the peptide terlipressin, initially being developed for the treatment of refractory ascites. Terlipressin, dosed differently, is approved in about 40 countries for other complications of liver cirrhosis arising from a similar disease pathway. Terlipressin is not available in the US and currently there are no FDA-approved drugs specifically for treating ascites. The Orphan drug candidate BIV201 represents a potential new treatment option for Americans suffering from refractory ascites, a life-threatening condition.

The study site Principal Investigator (PI) for the Phase 2a clinical trial is Jasmohan Bajaj, MD. Dr. Bajaj commented: "We are excited to participate in this initial clinical study of continuous low-dose infusion terlipressin in refractory ascites without major renal impairment. The results from our 6-patient trial will help to inform the remainder of the BIV201 clinical development program. It's an important study for patients with advanced ascites who could benefit from this drug therapy if it is eventually approved."

BioVie's medical advisor, Guadalupe Garcia-Tsao, MD, one of the world's leading experts in this field, will work closely with the clinical trial team as a consultant for the BIV201 clinical development program. Dr. Garcia-Tsao said: "Many US liver disease specialists are aware of terlipressin, which has a long track record of use in Europe and Asia for the treatment of two severe complications of cirrhosis, bleeding esophageal varices (BEV) and hepatorenal syndrome (HRS). This trial represents a key step on the path to potentially making this agent available to US clinicians for a challenging new indication, the management of patients with ascites that fails to respond to diuretics."

The Phase 2a trial is an open-label prospective study in a cohort of 6 patients with liver cirrhosis and ascites refractory to, or intolerant of, diuretic therapy requiring large-volume paracentesis. 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.

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. In March 2017, BioVie received notification from the FDA that it could initiate a Phase 2a US clinical trial. 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 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. For more information about BioVie and BIV201, please visit our website: www.biovieinc.com.

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 40,000 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.

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