ContraVir Pharmaceuticals Submits IND Application for CRV431 for NASH

ContraVir Pharmaceuticals, a biopharmaceutical company focused on the development of therapeutic drugs for the treatment of liver disease arising from non-alcoholic steatohepatitis (“NASH”) and chronic viral infection, today announced the filing of an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) for CRV431 for the treatment of 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. Robert Foster, ContraVir’s CEO. “We hope to receive confirmation that our submission has been accepted by the FDA, Center for Drug Evaluation and Research, in due course. This submission follows our compelling and positive preclinical and clinical work conducted to date, indicating that CRV431 offers a novel approach to treating NASH, with broader applications in liver disease.”

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.