ContraVir Pharmaceuticals Sets the Stage for CRV431 Development in NASH with Positive Results from Second Model of Liver Fibrosis
In this industry-standard model, liver fibrosis is induced in mice by administering carbon tetrachloride (“CCl4”). In the preclinical study, CCl4-treated mice received either 50 mg/kg of CRV431; 10 mg/kg of OCA; or a vehicle control. All were administered orally, once daily for six weeks. Liver fibrosis was then quantified using
“This is the second animal model, and the fifth study overall, in which CRV431 consistently demonstrated a statistically significant reduction in fibrosis,” said Dr.
This trial, conducted at the
- In the first study, conducted at the
Stelic Institutein Japan, STAM NASH mice were administered CRV431 orally, once daily for three weeks at a dose of 20 mg/kg, which decreased the extent of fibrosis by 57% compared to vehicle control (p < 0.01).
- In the second study, conducted at the
Scripps Research Institute, STAM NASH mice were administered CRV431 orally, once daily for six weeks at a dose of 50 mg/kg, which decreased the extent of fibrosis by 46% compared to vehicle control (p = 0.03).
- In the third study, conducted at the
Scripps Research Institute, STAM NASH mice were administered CRV431 orally, once daily for 11 weeks at a dose of 50 mg/kg, which decreased the extent of fibrosis by 37% compared to vehicle control (p = 0.01).
- In the fourth study, conducted at the
Scripps Research Institute, STAM NASH mice were administered CRV431 orally, once daily for 10 weeks at a dose of 50 mg/kg but at a much later stage of disease. In this study, fibrosis was reduced by 44%, confirming CRV431 efficacy across a wide range of disease time points (p=0.014).
ContraVir is developing CRV431 for NASH, fibrosis and other liver diseases such as viral hepatitis and hepatocellular carcinoma. A Phase 1, single ascending dose study of CRV431 was safe and well tolerated in humans.
ContraVir is a clinical stage biopharmaceutical company focused on the development of targeted therapies for liver disease arising from non-alcoholic steatohepatitis (NASH) and chronic hepatitis virus infection (HBV, HCV, HDV). The company’s lead drug candidate, CRV431, reduces liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH. Preclinical studies also have demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms. These diverse therapeutic activities result from CRV431’s potent inhibition of cyclophilin enzymes, which are involved in many disease processes. Currently in clinical phase development, CRV431 shows potential to play an important role in the overall treatment of liver disease - from triggering events through to end-stage disease. For more information, please visit www.contravir.com.
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Source: ContraVir Pharmaceuticals Inc.