BIV201

Our second drug candidate, BIV-201, is a novel, continuous infusion formulation of terlipressin is 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, BIV-201 has the potential to address an urgent unmet need.

BIV-201 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 BIV-201, has the potential to reduce the presence of ascites in the abdomen through vasoconstricting 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 outside the US, but has not been available in the US or Japan. It is approved in more than 40 countries for in hospital use for the treatment of two deadly conditions related to ascites called bleeding esophageal varices (BEV) and hepatorenal syndrome (HRS). The drug has been studied extensively overseas.

Orphan and Fast Track Status

In the United States, we have been granted an Orphan drug designation covering the use of BIV-201 (continuous infusion terlipressin) for the treatment of ascites due to liver cirrhosis. BIV-201 also has an Orphan drug designation for treating hepatorenal syndrome (HRS). The US Food & Drug Administration.
 
(FDA) has also granted Fast Track status for BIV-201. We recieved 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 believes 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 buildup whereas patients on standard of care had no change (p<0.001).