BIV201 Development Program
Estimated timeline as of April 2019
BIV201 is currently being evaluated in a mid-stage (Phase 2a) small open-label clinical trial in 6 patients with ascites that is refractory (no longer responding to diuretics) or intractable (cannot tolerate diuretic drugs). The projected clinical development timeline is shown below (as of mid-2018):
The Company believes that BIV201 therapy has the potential to dramatically improve the lives of thousands of Americans suffering from ascites due to advanced liver cirrhosis. Reducing ascites formation could increase patients’ quality of life and potentially avoid or reduce the number of life-threatening complications. However, unless the patient is able to regain liver function (for example, if an alcoholic quits drinking) he or she may eventually require a liver transplant.
In the United States, BioVie has secured both an Orphan drug designation and a patent covering the use of BIV201 (continuous infusion terlipressin) for the treatment of ascites due to liver cirrhosis. BIV201 also has an Orphan drug designation for treating hepatorenal syndrome (HRS). The US Food & Drug Administration (FDA) has also granted Fast Track status for BIV201. The Company has applied for patent protection around the world.
Based on terlipressin drug approvals around the world, BIV201 has the potential for future uses to treat other life-threatening conditions resulting from advanced liver cirrhosis, including BEV and HRS as described below. Securing marketing approvals for any of these new uses will require well-controlled clinical trials to satisfy the FDA and/or other countries’ regulatory requirements, none of which have commenced at this time.
Bleeding Esophageal Varices (BEV): The bursting of blood vessels lining the Esophagus as a consequence of very high blood pressure (“portal hypertension”) in the portal vein which supplies blood to the liver. This situation requires emergency treatment to avoid extensive blood loss and death.
Hepatorenal Syndrome (HRS): As liver cirrhosis and ascites progresses over time, patients’ kidneys may begin to fail, and this life-threatening condition may set in. It often occurs once a patient no longer responds to diuretic drugs that are used initially to help control ascites. The more advanced stage is called “type 1 HRS” and requires hospitalization as kidney failure, multiple organ failure (MOF), and death may occur within days if liver transplantation is not feasible.
Forward Looking Statements
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