BIV201 Development Program

Projected timeline

BioVie has completed a Phase 2a 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 early 2021):

BIV201 Timeline

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.

Intellectual Property

In the United States, BioVie has secured an Orphan drug designation 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.

Future Possibilities

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

This website contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause BioVie’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. BioVie has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are BioVie’s need for, and the availability of, substantial capital in the future to fund its operations and research and development. The fact is that BioVie’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in BioVie’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. BioVie undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.