Idenix Says FDA Places Hold on Hepatitis C Drug
Idenix Pharmaceuticals Inc. (IDIX), a developer of hepatitis C drugs, said U.S. regulators delayed study of one of its medications after a patient taking a competing therapy died from heart failure.
The hold on clinical trials was the second this month for Idenix drugs. They were held up after safety issues arose in testing of a Bristol-Myers Squibb Co. (BMY) hepatitis C therapy in the same family of compounds as Idenix’s. Bristol-Myers ended development of the drug Aug. 23 after it was linked to the death of one patient and kidney and heart problems in others.
Idenix, based in Cambridge, Massachusetts, hadn’t yet begun testing IDX19368 in humans. A more advanced drug, IDX184, was suspended in trials Aug. 16. The Food and Drug Administration has requested additional cardiac testing be done on those enrolled in a trial of that therapy, Idenix said today in a statement.
“We understand the clinical hold is a precautionary decision made by the FDA in light of the adverse events seen with BMS-986094,” Idenix Chief Executive Officer Ron Renaud said in the statement. There are qualities in the company’s therapies that “favorably differentiate the toxicity profiles from that of” Bristol-Myers’ drug, he said.
Idenix rose 2.3 percent to $6.15 at the close in New York. The shares have declined 17 percent this year.
More than 50 patients in a trial of IDX184 have been scheduled for echocardiograms, a heart-imaging test, and the company said it plans to submit data to the FDA in the next few weeks. Results have been normal for the small number of patients tested already, Idenix said.
“I don’t think it takes both Idenix drugs off the table, but it does slow them down,” said Brian Skorney, an analyst with Brean Murray Carret & Co. in New York, in a telephone interview. He has a hold rating on Idenix shares.
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