Idenix Pharmaceuticals Inc. (IDIX) said Friday that the U.S. Food and Drug Administration has lifted the partial hold placed on its lead candidate IDX184 for the treatment of Hepatitis C Virus, or HCV.
The FDA decision will allow Idenix to continue its 12-week phase IIb study of IDX184 in combination with standard care pegylated interferon and ribavirin (PegIFN/RBV) for the treatment of HCV. Nevertheless, investors were not impressed with the news and the company's shares dropped 10 percent in morning trade on the Nasdaq.
IDX184 is a pan-genotypic oral nucleotide polymerase inhibitor, and has showed a high resistance in vitro and potent antiviral activity in trials. Recent interim phase IIb data showed favorable antiviral activity and no serious events.
A clinical hold was issued by the FDA in September 2010 as a result of three cases of elevated liver function tests found during study in healthy volunteers of the combination of IDX184 and IDX320, an investigational HCV protease inhibitor.
Idenix conducted further preclinical studies, and concluded that the observed toxicity was likely caused by IDX320, whose development was later dropped.
At the start of 2011, the FDA removed a full clinical hold on IDX184, and the program was placed on partial hold. That allowed Idenix to initiate enrollment of treatment-naive genotype 1 HCV-infected patients into a randomized, double-blind, parallel group phase IIb trial of IDX184 in July 2011.
In January 2012, Idenix submitted interim phase IIb data for the first 31 patients to the FDA, along with a recommendation from the independent Data Safety Monitoring Board, and requested removal of the partial clinical hold on IDX184.
Following the FDA decision, Idenix said it can now initiate dosing of a further 30 patients and also begin a broad phase IIb study of IDX184.
Hepatitis C, one of the major causes of liver failure, is caused by hepatitis C virus, which is spread from person to person through contact with infected blood. About 3.2 million Americans, and 170 million people worldwide, are said to be chronically infected with HCV.
The standard treatment for hepatitis C is a 48-week treatment of both pegylated interferon and ribavirin. But the current standard care therapy is associated with poor response rates and significant side effects. Last year, new new drugs for Hepatitis C were approved by the FDA - Merck & Co.'s (MRK) Victrelis and Vertex Pharmaceuticals Inc.'s (VRTX) Incivek.
Since its inception in May 1998, Idenix has incurred significant losses each year.
IDIX is trading at $11.81, down $1.38 or 10.46%, on a volume of 5.5 million shares on the Nasdaq.
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