Treatment with BIV201 plus standard of care (SOC) resulted in a 34% reduction in ascites fluid during the 28 days after treatment initiation compared to the 28 days prior to treatment (p=0.0046). This improvement was significantly different from those treated with SOC only who experienced a mean increase in ascites fluid of 3.1% (BIV201 vs. SOC p=0.05). Patients who completed the treatment with BIV201 experienced a 53% reduction in ascites fluid (p=0.001), which was significantly different from those treated with SOC (p=0.007). This improvement was sustained in this group during the 3 months after treatment initiation as compared to the 3-month pre-treatment period (43% reduction, p=0.06). Overall treatment appeared to be well tolerated. There were no unexpected serious adverse events and overall safety was consistent with the patient population. Detailed results will be presented at an upcoming Scientific conference.
Michael Porayko, M.D., F.A.A.S.L.D., a recently retired Professor of Medicine and Chief of Hepatology at
“The data is very encouraging and supports that BIV201 should continue to be investigated as a potentially effective treatment for the reduction of ascites in patients with cirrhosis and refractory ascites, reducing the need for paracentesis and potentially improving both the symptoms related to fluid buildup and quality of life.”
Ascites is a common complication of advanced liver cirrhosis involving the accumulation of large volumes of fluid in the abdomen, often exceeding 5 liters, due to liver and kidney dysfunction. The FDA has never approved a drug to treat ascites, and once patients reach the refractory stage the estimated one-year survival rate is only approximately 50%1. BIV201 is a continuous infusion of terlipressin, a drug used in over 40 countries to treat related complications of liver cirrhosis that was recently approved in the US but not
The current trial (NCT04112199) evaluates the efficacy of BIV201 combined with standard-of-care (SOC), compared to SOC alone, for the treatment of refractory ascites. Terlipressin was administered with a continuous low dose infusion via a portable pump in two 28-day treatment cycles. The primary endpoints are the incidence of complications of at least Grade 2 severity, and the change in cumulative ascites in the 12-week period following randomization compared to a 12-week pre-treatment period. The BIV201 trial planned to enroll 30 patients to be treated in the home care setting.
“Compelling data from the first 15 patients led us to pause enrollment,” commented Cuong Do, BioVie’s President and CEO. “Given the high unmet need for this condition, we believe the most prudent course is to initiate conversations with the FDA on proceeding to the pivotal Phase 3 trial so that we can bring this innovation to patients as quickly as possible.”
BIV201 (continuous infusion terlipressin) has received Orphan Drug and Fast Track designations from the FDA for the treatment of ascites due to all etiologies except cancer. This would include, for instance, ascites due to advanced liver cirrhosis. First-to-market Orphan therapies typically receive seven years of market exclusivity in the US for the designated use.
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This press release contains forward-looking statements, including statements regarding the Company’s strategy, plans and objectives with respect to the clincical development of BIV201. Forward-looking statements may generally be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. Although
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1 Bureau et al. 2017
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