ContraVir Pharmaceuticals Submits IND Application for CRV431 for NASH
ContraVir’s proposed IND opening study is entitled, “An Open-Label Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of CRV431.” The study will enroll 24 patients, consisting of eight with mild, eight with moderate, and eight with severe hepatic impairment, based on Child-Pugh scores. Up to an additional 24 healthy subjects will serve as the control group. The objective of the IND opening study and proposed clinical development program is to characterize the role of CRV431 monotherapy as anti-fibrotic treatment in NASH patients.
“Our team has worked diligently to assemble this IND submission,” commented Dr.
This application, number IND142904, follows an earlier IND that was approved for the hepatitis B virus (“HBV”) indication. Under the previous IND for HBV, ContraVir has completed a phase 1 single ascending dose study in healthy human subjects, demonstrating good safety and tolerability and defining the pharmacokinetics of CRV431. A second clinical study of CRV431 examined the pharmacokinetics of CRV431 when co-administered with tenofovir disoproxil fumarate (“TDF”). The Company expects to initiate a third clinical study of CRV431, in the near future, to determine safety, tolerability, and pharmacokinetics after repeated, escalating oral dosing in HBV patients over a period of 28 days.
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.
Forward Looking Statements
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Source: ContraVir Pharmaceuticals Inc.