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Idenix's hepatitis program for two investigational agents placed on clinical hold by FDA, shares plummet
Tuesday, September 07 2010 | Comments
What's This?
The Food and Drug Administration placed a clinical hold on Idenix Pharmaceuticals Inc.'s development programs for hepatitis drug candidates IDX184 and IDX320 because of serious adverse events observed in a study evaluating a combination of the two agents among healthy volunteers.The news sent Idenix's shares down 46.9 percent.
The regulatory agency gave the company verbal notice of its decision after Idenix notified the FDA that three healthy subjects participating in a Phase I drug-drug interaction study of the combination of IDX184 and IDX320 demonstrated elevated results on liver function tests during postexposure safety visits. The company noted that the subjects' liver function test results returned to normal levels during follow-up.
Idenix has not yet received a formal letter from the FDA specifying the details of the hold, but based on discussions between the company and the agency, the concerns appear to focus on only the three cases observed in the IDX184/IDX320 combination trial, according to Jean-Pierre Sommadossi, Idenix's chief executive officer.
Sommadossi alluded to the safety and efficacy results of two other studies, in which the agents were evaluated alone, as support for the potential of the two compounds in treating patients with hepatitis C virus (HCV). One of the studies was a 14-day, Phase IIa trial of IDX184 in combination with peginterferon plus ribavirin in treatment-naive patients with HCV genotype 1. The other study, a three-day, double-blind, Phase I/II proof-of-concept trial, was conducted to evaluate the safety, tolerability, antiviral activity and pharmacokinetics of IDX320 in treatment-naive patients with HCV genotype 1.
Idenix said these two trials, as well as the combination study, have been completed and all active dosing has been finished.
The firm intends to further evaluate the cause of the serious adverse events and work with the FDA to "resolve this matter as quickly as possible," Sommadossi added.
Data from the trials are to be presented next month in Boston at the 61st annual meeting of the American Association for the Study of Liver Diseases.
Idenix shares closed at $3.18, down $2.81, in heavy volume on the Nasdaq.
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