Idenix reported that the Food and Drug Administration (FDA) has put two of its experimental therapies on clinical hold due to safety concerns. The two drugs are:
•IDX182 – HCV polymerase inhibitor (phase I) and,
•IDX320 –HCV protease inhibitor (phase II)
According to published reports, all of the studies have been completed so there are no patients who are currently receiving either medication. The drugs were put on hold by the FDA because of possible liver toxicities.
The next step in the process is for the FDA to review all of the data from the studies and make a determination if the clinical trials can proceed or if they will be canceled altogether.
Idenix has two other HCV drugs in clinical development—IDX375 and IDX184 (HCV polymerase inhibitors) in phase I and phase II studies.Share This Page