BIV201

Our second drug candidate, BIV201, is a novel, continuous infusion formulation of terlipressin being studied for the treatment of refractory ascites (or ascites due to liver cirrhosis). Given there are no drugs approved for this indication, which comes with a 50% mortality rate within 12 months, BIV201 has the potential to address an urgent unmet need.

BIV201 has shown the ability to reduce fluid build up in refractory ascites via constricting certain blood vessels, which contributes to improved blood flow in the kidneys and liver. It is delivered via a small, portable pump that patients can wear while engaging in typical tasks and activities at home.

Mechanism of Action

Investigative studies conducted overseas have shown that terlipressin, the active agent in BIV201, has the potential to reduce the presence of ascites in the abdomen by constricting the blood vessels where the blood is pooling, hence restoring blood flow through the kidneys and liver. This reduces portal vein pressure and increases blood volume in the arteries. Consequently, the body may respond by shutting down the RAAS system which has been generating the ascites.
 
Terlipressin has been available for decades in more than 40 countries for in-hospital use to treatment two deadly conditions related to ascites called bleeding esophageal varices (BEV) and hepatorenal syndrome (HRS). US FDA approved terlipressin for the in-hopsital treatment of HRS in September 2022. All these approvals involve bolus administration of terlipressin, which is associated with severe adverse effects.

BioVie's development of BIV201 is differentiated from prior efforts in three ways. Firstly, terlipressin is administered slowly throughout the day with the use of a continuous infusion pump instead of a single bolus, which has shown in clinical trials to reduce the incidence of drug-related severe adverse event. Secondly, it is administered on an outpatient basis instead of in hospitals, which targets chronic nature of ascites itself. Thirdly, it aims to reduce the incidence of complications arising from ascites such as BEV and HRS rather than treat the complications when they arise.

Orphan and Fast Track Status

In the United States, we have been granted an Orphan Drug Designation covering the use of BIV201 (continuous infusion terlipressin) for the treatment of ascites due to liver cirrhosis. BIV201 also has received Orphan Drug Designation for treating hepatorenal syndrome (HRS). The US Food & Drug Administration. FDA has also granted Fast Track status for BIV201.

We received new patent coverage of our novel liquid formulation of terlipressin around the world. This unique formulation has demonstrated stability at room temperature for at least 12 months, which we believe will be an important advantage for treating people with ascites in the home care setting.
 
The Phase 2a trial showed that BIV201 was safe and that patients taking BIV201 did not experience any drug-related serious adverse events.  The Phase 2b trial showed that patients who completed treatment with BIV201 experienced 53% reduction in ascites fluid build up whereas patients on standard of care had no change (p<0.001).