FDA removes full clinical hold on Idenix's HCV drug

Wed Feb 9, 2011 6:12pm EST

* Says to stop development of IDX320

* Says FDA places partial clinical hold on IDX184

* Says HIV drug licensed to Glaxo also put on hold (Adds details)

Feb 9 (Reuters) - Idenix Pharmaceuticals Inc (IDIX.O) said U.S. health regulators have removed the full clinical hold on one of its two experimental hepatitis C drugs, and it ceased the development of the other drug because of a toxicity issue.

In September, the U.S. Food and Drug Administration halted all trials of the experimental drugs after detecting liver function abnormalities in three healthy volunteers during an early-stage study of a combination of the compounds IDX184 and IDX320. [ID:nSGE6860G7]

The company said the observed toxicity in the drug-drug interaction study was likely caused by IDX320.

Idenix, which focuses on treating viral diseases, said the FDA has placed the IDX184 program on partial clinical hold.

It said it expects to initiate a Phase IIb trial of IDX184 in combination with pegylated interferon and antiviral pill ribavirin in the second half of 2011.

The company also said its HIV drug -- licensed to GlaxoSmithKline's (GSK.L) unit ViiV Healthcare -- was placed on a clinical hold by the FDA.

Idenix shares closed at $75.04 Wednesday on Nasdaq. (Reporting by Anand Basu in Bangalore; Editing by Joyjeet Das)

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