Schering-Plough hepatitis C protease inhibitor in phase 2 trial, approved for FDA fast track

By Lisa Kerner

Erie, Pa., Jan. 30 - Schering-Plough said the Food and Drug Administration has granted fast track designation to its investigational oral hepatitis C protease inhibitor (SCH 503034).

SCH 503034 is an orally active inhibitor of the hepatitis C virus serine protease that inhibits hepatitis C virus replication. It is in phase 2 clinical development for the treatment of chronic hepatitis C virus infection, according to a company news release.

Fast track designation allows the FDA to expedite review of drugs and biologics for serious or life-threatening conditions and which demonstrate the potential to address unmet medical needs, the company said.

Schering-Plough is conducting a large, randomized phase 2 dose-finding study involving 300 patients worldwide. This study evaluates the safety and efficacy of SCH 503034 in combination with Peg-Intron, with and without added ribavirin, for 24 or 48 weeks in patients with chronic hepatitis C virus genotype 1 who were nonresponders to previous peginterferon and ribavirin combination therapy.

The primary objective of this study is to determine the safe and effective dose range of SCH 503034 in combination with Peg-Intron.

SCH 503034 has demonstrated potent antiviral activity and was well-tolerated, both as monotherapy and in combination with Peg-Intron (peginterferon alfa-2b), (2) in phase 1 clinical studies. Patients in this study were chronically infected with hepatitis C virus genotype 1 and were nonresponders to previous therapy, including peginterferon and ribavirin combination therapy.

Hepatitis C virus genotype 1 is the most common form of the virus worldwide and is considered the most difficult to treat successfully, the company said.

An additional preclinical and phase 1 clinical development program is ongoing to support the potential broad utility of SCH 503034 in treating chronic hepatitis C.

Results of phase 1 clinical studies with SCH 503034, including in healthy subjects, were presented at the 56th Annual Meeting of the American Association for the Study of Liver Diseases in November.

Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. The company is based in Kenilworth, N.J.

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