Benzinga | Mar 9, 2021 09:16AM EST

BioVie Commences Patient Screening in Phase 2 Clinical Trial

BioVie Inc. (NASDAQ:BIVI) ("BioVie" or "Company"), a clinical-stage company developing innovative drug therapies for liver disease, today announced the start of patient screening in the Company's Phase 2 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--will be initiated at nine prestigious research centers in the U.S. One center has recently been activated and has begun screening patients. The company expects to activate additional centers over the next several weeks.

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% (Bureau et al. 2017). BIV201 is a continuous infusion of terlipressin, a drug used in over 40 countries to treat related complications of liver cirrhosis that has not been approved in the US or Japan. With a novel prefilled syringe format that is stable at room temperature, BIV201 could potentially provide a superior terlipressin drug delivery system throughout the world.

BioVie previously conducted a Phase 2a trial of continuous infusion terlipressin in this patient population at a Veterans Administration hospital. The pharmacokinetics of terlipressin following continuous infusion generated in this study determined for the first time that administration of terlipressin as a continuous infusion avoids high, potentially harmful, peak blood concentrations associated with intermittent IV bolus dosing. The study also supported that the drug was well tolerated overall and that it was feasible to administer terlipressin by continuous infusion in an outpatient setting.

The current trial will evaluate the efficacy of BIV201 in addition to standard-of-care (SOC) compared to SOC alone for the treatment of refractory ascites. Terlipressin will be administered with a continuous low dose infusion administered 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 plans to enroll 30 patients to be treated in the home care setting.

"With no approved treatments and a poor one-year survival we believe there is a clear unmet medical need for an effective drug treatment for patients suffering from refractory ascites," said Terren Peizer, chairman and chief executive officer of BioVie. "Interest from the research community has been strong, which we believe speaks to the need for new therapies for this Orphan drug indication. Many of our trial sites have affiliated paracentesis clinics that treat large numbers of ascites patients on a regular basis, and we expect enrollment to commence and accelerate in the coming weeks."