Idenix Pharmaceuticals, Inc.
) recently received a verbal notice from the US Food and Drug
Administration (FDA) informing the company about a clinical hold on
its hepatitis C candidate, IDX19368.
Idenix had submitted an investigational new drug (IND)
application for IDX19368 in July this year. The company was looking
to commence studies in the third quarter. However, considering the
clinical hold, the initiation of studies with IDX19368 could be
delayed. IDX19368 was not exposed to any patients to date.
We remind investors that earlier this month Idenix had received
another verbal notice from the FDA, which placed the company's
other hepatitis C candidate -- IDX184 -- on partial hold.
The FDA had 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 HCV.
Idenix has already scheduled 50 patients for echocardiograms and
expects to submit data to the US regulatory authority in the coming
We note that, in June 2012, Idenix had reported positive interim
data from the phase IIb clinical study. The data demonstrated that
patients on IDX184 combination therapy achieved 100% and 80%
sustained virologic response (SVR) with 100 mg and 50 mg doses,
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 had
plans of initiating another study on IDX184 by the end of 2012,
which might get delayed due to the FDA's action. Presently no
patients are receiving IDX184 around the globe.
The FDA placed IDX19368 on clinical hold to review its safety
concerns after serious cardiac-related adverse events were found to
be associated with
Bristol-Myers Squibb Company
) BMS-986094 (formerly known as INX-189). BMS-986094 is also a
nucleotide polymerase inhibitor being developed for the treatment
of HCV. Bristol-Myers recently decided to discontinue with
BMS-986094 due to its safety issues.
Bristol-Myers has agreed to help Idenix with relevant
information on BMS-986094 to resolve this issue. We remind
investors that BMS-986094 was added to Bristol-Myers' pipeline
following its acquisition of Inhibitex Inc. earlier this year.
The management mentioned that both IDX19368 and IDX184 fall in
the same broader class and have same metabolite as the
Bristol-Myers candidate. But many attributes of Idenix's compounds
differ from that of BMS-986094.
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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