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Idenix hepatitis drugs on clinical hold

The US Food and Drug Administration has said Idenix must cease clinical investigations of two hepatitis C drugs after elevated liver function tests

Idenix Pharmaceuticals has been informed by the US Food and Drug Administration that it must cease clinical investigations of its hepatitis C drugs IDX184 and IDX320 due to elevated liver function tests in some healthy volunteers.

IDX184 is a once-daily oral nucleotide prodrug that makes use of the company's proprietary liver-targeting technology, which is intended to maximise efficacy and limit systemic side effects by targeting high levels of nucleoside triphosphate to the liver. IDX320 is a once-daily protease inhibitor.

The company said that it has not yet received formal written notice from the FDA on the matter, but that the federal agency had communicated verbally that programmes for the two drugs must be placed on clinical hold.

The decision was made after Idenix notified the FDA of elevated liver function tests in three subjects during post-exposure safety visits that were part of a phase I drug-drug interaction study of the combination of IDX184 and IDX320 in healthy volunteers. The tests returned to nearly normal levels during follow-up.

Idenix said it remains committed to developing the drugs and will engage in discussions with the FDA about the best way forward. The company noted that the FDA has not yet had a chance to review data from several recently completed studies of the drugs, including three-month chronic toxicology studies of IDX184, a 14-day study of IDX184 in combination with pegylated interferon/ribavirin, a three-day proof-of-concept study of IDX320, and the drug-drug interaction study.

The drug-drug interaction study enrolled two groups of 10 healthy subjects. In each group, eight subjects received the active drug, while two subjects were given a placebo. Active-drug subjects in the first group were given 400 mg once-daily of IDX320 for a week and then had 100 mg once-daily of IDX184 added on for a second week. The order was reversed in the second group.

With the exception of the three elevated liver function tests, the drug combination appeared to be safe and well tolerated, according to the company. Idenix said it does not yet have an explanation as to why the liver tests were elevated but will work with outside experts and the FDA to discover the cause.

8th September 2010

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