BioVie Reviews Key Accomplishments in 2017 and Updates on Phase 2a Clinical Trial Progress
BEVERLY, MA--(Marketwired - January 16, 2018) - BioVie Inc. (OTCQB: BIVI), a clinical-stage company focused on the development and commercialization of innovative drug therapies for liver disease, today reviewed key milestones achieved over the past year and provided a general update on the progress of its mid-stage (Phase 2a) clinical trial of BIV201 in refractory ascites patients.
"We made excellent progress in 2017," commented CEO Jonathan Adams. "We began the year without an investigational new drug (IND) clearance, which occurred in April. Next we obtained Institutional Review Board (IRB) approval to conduct a Phase 2a clinical trial at the McGuire Research Institute in Richmond, VA, and by November had treated our first two refractory ascites patient with Orphan drug candidate BIV201. In May, our core US patent covering the treatment ascites due to liver cirrhosis was issued by the US Patent & Trademark Office, and the Company subsequently filed for patent protection in Japan and China. In December we secured FDA Fast Track status."
To date, two refractory ascites patients have been treated in the Phase 2a open-label clinical trial of BIV201 of the 6 total patients to be enrolled. While no conclusions can be drawn from only two subjects, both patients indicated evidence of response on certain efficacy measures. Refractory ascites patients are extremely ill with a very poor quality of life. They have frequent hospitalizations due to disease complications and a mortality rate of approximately 50% at 6 to 12 months. Both patients in the BIV201 trial experienced medical complications, but the drug itself (continuous infusion terlipressin) was well tolerated. After reviewing the results, the Data and Safety Monitoring Board (DSMB) supported continuing the clinical study.
The results for all 6 refractory ascites patients planned for BioVie's Phase 2a clinical trial of BIV201 are expected by the second quarter of 2018. In addition to evaluating the safety of BIV201 therapy, the study will examine indicators of efficacy, including reduction in ascites fluid volume and the need for paracentesis procedures (the mechanical withdrawal of large amounts of ascites fluid by large bore needle). The study will also evaluate the steady-state pharmacokinetics (PK) of terlipressin and its active metabolite. Additional information on this clinical trial is available at www.clinicaltrials.gov (identifier: NCT03107091). The safety and efficacy of BIV201 (continuous infusion terlipressin) as a treatment have not been established with the FDA.
The Company's new drug candidate, BIV201, has Orphan-drug designation and US patent protection, and 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 the most common serious complication of advanced liver cirrhosis. The FDA has never approved a drug specifically indicated for the treatment of 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. BioVie has applied for additional Orphan-drug designations for other life-threatening conditions associated with advanced liver cirrhosis.
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 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.
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 guarantee the approval of patents or Orphan-drug applications, nor the completion or success of its Phase 2a clinical trial.