Liver Cirrhosis

BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing transformative therapies to overcome unmet medical needs in chronic debilitating conditions.

Chronic Liver Disease

1. Varies by ethnicity – Setiawan, 2016 (link)
2. CDC National Vital Statistics Report, 2017 Data (link)
3. HCUP Nationwide Readmissions Database 2016 Links to our poster on the Investors page (link)
Chronic liver disease (CLD) including cirrhosis is the 11th leading cause of death due to disease in the US, killing about 42,000 people annually. Liver cirrhosis patients with ascites undergo 116,000 hospitalizations each year incurring an estimated $5 billion in annual patient treatment costs.

There are 3 major causes of liver cirrhosis. Alcoholism accounts for about 25% and is rising. Hepatitis C is another leading cause, but the new antiviral therapies will eventually reduce the number of these patients. Unfortunately, they arrived too late for many hepatitis C patients whose livers have already been destroyed by the virus. The fastest-growing cause of liver cirrhosis is NASH, which comes from fatty-liver disease due to obesity and is now at epidemic proportions. NASH is now the leading reason for liver transplant.

It takes decades for the cirrhosis damage to accumulate and destroy the liver. At first the liver is “compensated” meaning that it’s still cleansing the blood and doing other important jobs. Once it reaches the “decompensation” stage it’s no longer functional, and ascites and other deadly complications start to occur.

How Ascites Develops

(the expert consensus in plain language)

In advanced liver cirrhosis, the liver becomes “clogged” and the blood pools in the region below the liver, called the splanchnic bed, because it can’t flow through. This increases pressure in the portal vein which supplies blood to the liver.

With blood pooling below the liver, the blood volume in the arteries decreases and the patient experiences “low effective blood volume.” In an effort to correct this situation, the brain send signal via the renin-angiotensin-aldosterone system(“RAAS”) to the kidneys to retain extreme amounts of water and salt. The excess liquid weeps from the lymphatic system and collects in the abdomen – which is when ascites appears.

Anticipated Mechanism of Action

Investigative studies conducted overseas have shown that terlipressin, the active agent in BIV201, has the potential to correct this problem by vasoconstricting the blood vessels where the blood is pooling and 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 (it is not available in the US or Japan). It is approved in more than 40 countries for treating two deadly conditions related to ascites called bleeding esophageal varices (BEV) and hepatorenal syndrome (HRS) in hospitals. The drug has been studied extensively overseas and its efficacy and safety profiles in BEV and HRS have been elucidated by hundreds of scientific publications.
Refractory Ascites 50% within 6 to 12 months1
Hepatorenal syndrome-Acute Kidney Injury (HRS-AKI) Median survival of 1.7 to 4 weeks for HR type 13
Bleeding esophageal varices (BEV) 15 to 25% mortality at 6 weeks after bleeding episode2
1. Varies by ethnicity – Setiawan, 2016 (link)
2. CDC National Vital Statistics Report, 2017 Data (link)
3. HCUP Nationwide Readmissions Database 2016 Links to our poster on the Investors page (link)

BIV201 Potential Future Disease Targets

BIV201 is being developed for treating refractory ascites patients, who no longer respond to diuretic drugs and required repeated paracentesis procedures (the physical withdrawal of large amounts of ascites fluid from the abdomen with a large-bore needle). Eventually the Company may pursue FDA approvals to market BIV201 for two related conditions due to advanced liver cirrhosis: bleeding esophageal varices (BEV) and hepatorenal syndrome (HRS). All of these conditions are very deadly as shown in the table.

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 is applying for for patent coverage of its novel liquid formulation of terlipressin around the world. This unique formulation has demonstrated stability at room temperature for at least 12 months, which BioVie believes will be an important advantage for treating ascites patients in the home care setting.

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 HRS-AKI and BEV 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--Acute Kidney Injury(HRS-AKI): 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.

Publications

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.
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