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Business Overview
12 Months Ended
Dec. 31, 2018
Business Overview  
Business Overview

1. Business Overview

 

ContraVir Pharmaceuticals Inc. (“ContraVir” or the “Company”) is a biopharmaceutical company focused on the development of targeted pharmaceutical therapies for liver disease. Liver disease may arise from chronic alcohol use, chronic hepatitis B, C and D virus (HBV, HCV, HDV), and non-alcoholic steatohepatitis (NASH). Fat accumulation in the liver (steatosis), inflammation, ballooning degeneration, and fibrosis are some of the changes observed with liver disease. In some instances, disease may progress to cirrhosis and hepatocellular carcinoma (HCC), the most common type of primary liver cancer.

 

The Company is developing two novel oral compounds. The first, ‘CRV431’, is a cyclophilin inhibitor that targets specific isomerases that play an important role in protein folding in health and in disease. To date, in vitro and/or in vivo studies have demonstrated reductions in HBV DNA, HBsAg, HBeAg, inhibition of virus uptake (NTCP transport inhibition), and stimulation of innate immunity. Importantly, in vivo studies in a NASH model of fibrosis and HCC have repeatedly demonstrated CRV431 reduces fibrosis scores and overall liver tumor burden. Hence, CRV431 is a pleiotropic molecule that may not only treat liver disease, but may also serve to reduce important risk factors (e.g., HBV) for developing the disease. The Company has completed a phase 1 study with CRV431 demonstrating safety, tolerability, and pharmacokinetics (PK).

 

The Company’s second compound, ‘TXL’, is more advanced clinically (completed phase 2). TXL is a nucleotide pro-drug of tenofovir that inhibits hepatitis B viral replication, and targets the liver, the reservoir for the hepatitis B virus. CRV431 and TXL have differing modes of action and, therefore, may complement one another in the treatment of HBV. Both compounds address a significant risk factor for the development of liver disease, HBV, whereas CRV431 additionally targets advancing stages of liver disease (e.g., fibrosis/HCC).

 

On June 10, 2016, the Company, through a wholly-owned subsidiary now known as ContraVir Research Inc., acquired Ciclofilin Pharmaceuticals, Inc. a biopharmaceutical company incorporated on January 13, 2014 in California and reincorporated in Delaware on October 15, 2014. Ciclofilin Pharmaceuticals, Inc. had one wholly-owned subsidiary, Ciclofilin Pharmaceuticals Corp., incorporated in Canada on January 24, 2014. Together, Ciclofilin Pharmaceuticals, Inc. and Ciclofilin Pharmaceuticals Corp (“Ciclofilin”) are a wholly-owned subsidiary known as ContraVir Research Inc. that specializes in the development of cyclophilin inhibitors, an emerging class of drugs for infectious, inflammatory, and degenerative diseases. Ciclofilin’s lead drug candidate, CRV431, is a potent cyclophilin inhibitor that blocks multiple HBV activities including entry into cells and replication, and is currently in pre-clinical development.