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news.Schering-Plough has completed patient enrollment in the first part of its ongoing phase II clinical study to determine the appropriate dose range of SCH 503034, its investigational oral hepatitis C protease inhibitor capsules.
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SCH 503034 is being evaluated in a large phase II study in combination with peg-intron (peginterferon alfa-2b) for the treatment of patients chronically infected with hepatitis C virus (HCV) genotype 1 who were nonresponders to peginterferon and ribavirin combination therapy.
The current standard of care in treating chronic hepatitis C is the combination of peginterferon and ribavirin. HCV genotype 1 is the most common form of the virus worldwide and is considered the most difficult to treat successfully. Currently, no alternative therapy has been shown effective for the large number of patients who failed previous therapies, representing an area of great unmet medical need.
The company also reported that with the completion of enrollment of the original protocol doses of 100, 200, 400mg three times a day, it continues to explore a full range of dosing options for the drug. As such, the ongoing phase II study has been expanded to include an additional treatment arm with 800mg of the drug administered three times a day in combination with peg-intron for 24 weeks. This arm will enroll up to an additional 65 patients.
In all, the ongoing phase II study will enroll a total of approximately 350 patients at centers in the US and Europe, making it the largest clinical study to date with an HCV protease inhibitor.
“SCH 503034 is one of the most advanced investigational agents in this new class of drugs that target key HCV proteins necessary for viral replication,” said Dr Robert Spiegel, chief medical officer and senior vice president, Schering-Plough Research Institute. “This promising oral antiviral agent has the potential to greatly improve treatment for all hepatitis C patients, and may lead to future regimens that are more effective, better tolerated and shorter in duration.”