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Two drug candidates from Idenix Pharmaceuticals Inc., intended to treat Hepatitis C virus, have been put on clinical hold by the U.S. Food and Drug Administration amid safety concerns stemming from the drug-drug interaction. Idenix noted in a press release today that it received verbal notice of the FDA order on Friday.
The drug-drug interaction concerns pertain to the the company’s IDX184 and IDX320 programs. The Cambridge biotech said it notified the FDA after three healthy volunteers returned liver function abnormalities detected in post-exposure safety visits; the liver function tests in these patients have since returned to normal.
“Based upon the safety and antiviral activity we observed in the IDX184 14-day study and the IDX320 3-day proof-of-concept study, both in HCV-infected patients, we remain committed to the future potential of these drug candidates,” said Idenix chairman and CEO Jean-Pierre Sommadossi. “We will work closely with independent experts and our external safety committee to better understand the cause of these serious adverse events.”
Idenix (Nasdaq: IDIX) is focused on treating human viral diseases. The company signed a deal last year with drug giant GlaxoSmithKline PLC potentially worth more than $400 million, granting GSK exclusive worldwide license rights to its IDX899 drug. IDX899 is a new non-nucleoside reverse transcriptase inhibitor in the Phase 2 clinical stage, which the company considers a potential treatment for HIV/AIDS that can address the issue of viral resistance and the side effects associated with this drug class.
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