Achillion Readies A Nuc Combo As Acquisition Speculation Swirls
This article was originally published in Pharmaceutical Approvals Monthly
The biotech can move forward with an HCV combo that includes its Phase I nuc and its protease inhibitor now that FDA has partially lifted the hold on the drug.
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Phase II trial of alisporivir plus ribavirin began after FDA modified its partial clinical hold; previous regimen included peg-interferon.
HCV-focused biotech tells J.P. Morgan conference audience it is making IDX719, its Phase II NS5A inhibitor, its lead program and hopes to start a non-exclusive combination trial with another company’s protease inhibitor this year.
Idenix announced FDA has placed a partial clinical hold on its hepatitis C candidate IDX184 after Bristol-Myers Squibb was forced to halt a study of its similar drug following a serious cardiovascular event. The news sparked new worries concerning a class effect for nucleoside polymerase inhibitors, though Gilead stood by its candidate GS7977’s clean CV profile and Idenix said no CV toxicities have been associated with ‘184.