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BioVie Announces First Patient Enrolled in BIV201 Phase 2b Clinical Trial for Ascites
SANTA MONICA, Calif., June 24, 2021 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI) ("BioVie" or "Company"), a clinical-stage company developing innovative
About this update from Biovie Inc.
[{"type":"text","content":"SANTA MONICA, Calif., June 24, 2021 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI) (\"BioVie\" or \"Company\"), a clinical-stage company developing innovative drug therapies for the treatment of liver disease and neurological and neurodegenerative disorders and certain cancers, today announced that the first patient has been enrolled in the Company’s Phase 2b trial of BIV201 (continuous infusion terlipressin) for the treatment of refractory ascites. The trial—A Study for Evaluation of BIV201 to Reduce Ascites and Complications in Patients with Cirrhosis and Refractory Ascites—is being conducted at nine prestigious research centers in the U.S. (NCT04112199). Two additional patients have consented to the pre-randomization observation period, and 7 more potential participants have been identified through pre-screening. “With no approved treatments and a poor one-year survival there is a clear unmet medical need for an effective drug treatment for patients suffering from refractory ascites,” said Cuong Do, chief executive officer of BioVie. “The initiation of patient enrollment is a key milestone, and we have activated most of our clinical trial sites with additional potential participants identified. Many of our sites have affiliated clinics that perform paracentesis procedures on large numbers of ascites patients on a regular basis – this is the physical withdrawal of ascites fluid with a large bore needle which is the current standard of care (SOC) since there are no FDA-approved drugs for treating this condition. We expect enrollment to accelerate in the coming weeks, and are currently on track to complete enrollment of all 30 subjects this summer, and anticipate a topline data readout in early 2022.” 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. An estimated 20,000 Americans suffer from refractory ascites, which means that their ascites no longer responds to off-label diuretic therapy or they cannot tolerate these drugs. The FDA has never approved a drug for treating ascites, and once patients reach the refractory stage the estimated one-year survival rate is only approximately 50% (Bureau et al. 2017). BIV201 is a continuous infusion of terlipressin, a drug used in over 40 countries...