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ContraVir Pharmaceuticals Submits IND for NASH Drug

IND positions NASH as a second indication for CRV431, in addition to HBV

By: Cassandra Gervolino

ContraVir Pharmaceuticals, Inc. has filed an Investigational New Drug (IND) application with the U.S. FDA for CRV431 for the treatment of NASH. ContraVir’s proposed IND study is entitled, “An Open-Label Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of CRV431.” 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 chief executive officer. “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.”

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