Idenix Pharmaceuticals, Inc.
) recently suffered a huge setback when it received a verbal notice
from the US Food and Drug Administration (FDA) placing a partial
clinical hold on its hepatitis C candidate, IDX184. IDX184, a
nucleotide polymerase inhibitor, is being evaluated as a treatment
for hepatitis C virus (HCV). Idenix shares were down significantly
on the news.
The FDA has asked Idenix to conduct additional cardiac tests on
patients in the ongoing phase IIb study of IDX184 in combination
with pegylated-interferon and ribavirin for the treatment of
In June 2012, Idenix had reported positive interim data from the
study. The data demonstrated that patients on IDX184 combination
therapy achieved 100% and 80% sustained virologic response (SVR)
with 100 mg and 50 mg dose, respectively.
In July 2012, the safety data of the trial was reviewed by an
independent data safety monitoring board and found to be consistent
with that of pegylated-interferon and ribavirin alone. Idenix
planned the initiation of another study on IDX184 by the end of
2012, which might get delayed due to the FDA's action.
The FDA placed a partial clinical hold on IDX184 to review its
safety after serious cardiac-related adverse events were found to
be associated with
Bristol-Myers Squibb Company's
) BMS-986094 (formerly known as INX-189). BMS-986094 is also a
nucleotide polymerase inhibitor being developed for the treatment
We remind investors that BMS-986094 was added to Bristol-Myers'
pipeline following its acquisition of Inhibitex Inc. earlier this
year. On a conference call to address the issue, Idenix noted that
the two drugs, IDX184 and BMS-986094, are significantly
We currently have a Neutral recommendation on Idenix. The stock
carries a Zacks #3 Rank (Hold rating) in the short run.
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