Development of Two HCV Experimental Drugs Halted | Hepatitis Central

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Development of Two HCV Experimental Drugs Halted

The Editors at Hepatitis Central
September 27, 2010

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Liver-related side effects prompted the FDA to stop trials with two Idenix drugs in development for treating Hepatitis C.

FDA Suspends Trials of Experimental HCV Regimen IDX184 plus IDX320 Due to Liver Toxicity Concerns

Cambridge, Mass. — September 7, 2010 — Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that the company received verbal notice on Friday, September 3, 2010 from the U.S. Food and Drug Administration (FDA) that the IDX184 and IDX320 programs have been placed on clinical hold. A clinical hold is an order issued by the FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. This decision was made after Idenix notified the FDA of three serious adverse events that occurred during a drug-drug interaction study of the combination of IDX184 and IDX320 in healthy volunteers.

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