BioVie announces partnership with the American Liver Foundation
Campaign to improve education on ascites due to cirrhosis of the liver and raise awareness of BioVie’s phase 2b study of BIV201 for refractory ascites
RENO, Nevada, December 09, 2021 (GLOBE NEWSWIRE) – BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”), a clinical-stage company that develops innovative drug therapies for the treatment of heart disease. liver and neurological and neurodegenerative disorders, today announced that the Company is partnering with the American Liver Foundation (ALF) as part of an educational campaign on chronic hepatic cirrhosis and its complications and to educate potential patients and healthcare providers about the Company’s phase 2b study of BIV201 (terlipressin continuous infusion ). The trial – A study for the evaluation of BIV201 to reduce ascites and complications in patients with cirrhosis and refractory ascites – is being conducted at ten prestigious research centers in the United States (NCT04112199).
“We are grateful to work with the ALF on this awareness campaign,” said Cuong V. Do, CEO of BioVie. “Due to the rapid rise in non-alcoholic steatohepatitis (NASH) and other persistent causes of liver cirrhosis, the severe complication of ascites is placing an increasing burden on the US health system. Our goal for this program is to help improve understanding among potential patients and the medical community of disease-related conditions such as ascites and hepatorenal syndrome and to assess more applicants for enrollment in our program. clinical development.
“Our mission is to provide education, advocacy and other supportive services to all people whose lives are affected by liver disease,” said Lorraine Stiehl, CEO of the American Liver Foundation. “We are grateful for the support of our industry partners and excited to work with BioVie to strengthen their efforts to make a difference in the lives of cirrhotic patients with refractory ascites. “
Ascites is a common complication of advanced hepatic cirrhosis involving the accumulation of large volumes of fluid in the abdomen, often exceeding 5 liters, due to liver and kidney dysfunction. It is estimated that 20,000 Americans suffer from refractory ascites, which means that their ascites no longer responds to off-label diuretic therapy, or that they cannot tolerate these drugs. The FDA has never approved a drug for the treatment of ascites, and once patients reach the refractory stage, the estimated one-year survival rate is only around 50% (Bureau et al. 2017). BIV201 is a continuous infusion of terlipressin, a medicine used in over 40 countries to treat complications from cirrhosis of the liver that is not available in the United States or Japan.
BioVie’s ongoing Phase 2b clinical trial is evaluating the efficacy of BIV201, which has an orphan drug designation, in addition to the standard of care (SOC) versus SOC alone for the treatment of refractory ascites in the disease. home care setting. Ascites patients or their caregivers who wish to learn more about this study should visit: www.bioviepharma.com/ascites-clinical-trials-biv201/ or the clinical trials section of the ALF website: https://liverfoundation.org /.
The patent pending liquid formulation of terlipressin in a pre-filled syringe format (BIV201) is used in this trial to provide a continuous low dose infusion with a portable pump over two 28 day treatment cycles. The main endpoints are the incidence of serious disease-related complications and the change in the cumulative volume of ascitic fluid in the BIV201 treated group (20 patients) compared to the control group (10 patients). If the results are positive, the Company plans to conduct a potentially pivotal Phase 3 trial starting in 2022. BioVie previously conducted a Phase 2a trial of BIV201 in a similar patient population at a Veterans Administration hospital. . The pharmacokinetics (PK) of terlipressin after continuous infusion generated in this study determined for the first time that administration of terlipressin as a continuous low-dose infusion avoids the potentially harmful high peak blood levels associated with the intermittent IV bolus administration. The study also found that the drug was generally well tolerated and that it was possible to administer terlipressin by continuous infusion on an outpatient basis.
About the American Liver Foundation
The American Liver Foundation (ALF) is the largest patient advocacy organization dedicated to liver disease. The mission of the ALF is to promote education, advocacy, support services and research for the prevention, treatment and cure of liver disease. The American Liver Foundation receives contributions and funding from sponsors of clinical trials and studies. The American Liver Foundation does not evaluate or endorse any clinical trial or study, and is not affiliated with any of the sponsors.
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative therapies to overcome unmet medical needs in chronic debilitating diseases. In liver disease, the Company’s orphan drug candidate BIV201 (terlipressin continuous infusion), with FDA Fast Track status, is being evaluated in a phase 2 study in the United States for the treatment of refractory ascites due to cirrhosis of the liver with prominent results expected at half time. 2022. The Company is also planning a potentially pivotal Phase 3 study of BIV201 in the treatment of hepatorenal-acute renal failure syndrome (HRS-AKI) in 2022, subject to FDA review and clearance. BIV201 is administered as a patent pending liquid formulation. The active agent is approved in about 40 countries for complications related to advanced hepatic cirrhosis, but is not available in the United States or Japan. In neurodegenerative diseases, BioVie has acquired the assets of NeurMedix Inc. including NE3107 which inhibits the inflammatory activation of ERK and NFB (e.g. TNF transcription) which leads to neuroinflammation and insulin resistance , but not their homeostatic functions (eg, insulin signaling and neural growth and survival). Both are the engines of Alzheimer’s and Parkinson’s disease. The Company is conducting a multicenter, phase 3, randomized, double-blind, placebo-controlled, parallel-group, potentially pivotal study to assess NE3107 in subjects with mild to moderate Alzheimer’s disease (NCT04669028) . It is estimated that six million Americans suffer from Alzheimer’s disease. BioVie has initiated this study and is targeting primary completion by the end of 2022. A Phase 2 study of NE3107 in Parkinson’s disease was cleared by the FDA to start in early 2022, and related compounds have additional potential to treat certain cancers. NE3107 is patented in the United States, Australia, Canada, Europe, and South Korea. For more information, visit www.bioviepharma.com.
This press release contains forward-looking statements, which may be identified by words such as “expect”, “look forward to”, “anticipate”, “intend”, “plan”, “believe” , “Seek”, “estimate”, “will”, “project” or words with similar meaning. Although BioVie Inc. believes that these forward-looking statements are based on reasonable assumptions, it cannot guarantee that its expectations will be met. Actual results may differ materially from those expressed or implied in these statements due to the Company’s ability to successfully raise sufficient capital on reasonable terms or not at all, available liquidity and contractual and statutory limitations. that could affect our ability to pay future dividends, our ability to complete our clinical studies and obtain approval of our product candidates, to successfully defend against potential future litigation, changes in local or national economic conditions as well as various additional risks, many of which are now unknown and generally beyond the control of the Company, and which are detailed from time to time in reports filed by the Company with the SEC, including quarterly reports on Form 10-Q , reports on Form 8-K and annual reports on Form 10-K. BioVie Inc. assumes no obligation to update any statements contained in this document (including forward-looking statements), except as required by law.
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