Idenix Provides Update on IDX19368 Development Program
August 27 2012 - 7:30AM
Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), a biopharmaceutical
company engaged in the discovery and development of drugs for the
treatment of human viral diseases, today announced that the Company
received verbal notice from the U.S. Food and Drug Administration
(FDA) that a clinical hold has been placed on IDX19368, the
Company's next-generation nucleotide polymerase inhibitor under
development for the treatment of hepatitis C virus (HCV) infection.
This news follows an announcement that Idenix made on August 16,
2012 related to a partial clinical hold placed on IDX184, the
Company's lead nucleotide polymerase inhibitor also under
development for the treatment of HCV.
The FDA verbally informed Idenix that it placed IDX19368 on
clinical hold due to concerns related to the serious
cardiac-related adverse events reported for HCV patients treated
with BMS-986094, a nucleotide polymerase inhibitor previously under
development by Bristol-Myers Squibb Company. To date, no patients
have been exposed to IDX19368.
"Based on our discussions with the FDA, we understand the
clinical hold is a precautionary decision made by the FDA in light
of the adverse events seen with BMS-986094," said Ron Renaud,
President and CEO. "Both IDX184 and IDX19368 fall into the same
broader class of NS5B inhibitors, and share the same active
metabolite as BMS-986094. However, there are many attributes of our
compounds, particularly the prodrug approach, that we believe
favorably differentiate the toxicity profiles from that of
BMS-986094. We recently learned that Bristol-Myers Squibb has
agreed to share relevant information on BMS-986094 with us and hope
this helps us to resolve this issue quickly."
As part of the partial clinical hold placed on IDX184, the FDA
has requested additional cardiac testing of patients in the ongoing
phase IIb clinical trial of IDX184. More than 50 patients have been
scheduled for echocardiograms, and the Company is on track to
submit these data to the FDA in the coming weeks. To date,
echocardiograms have been performed on a small number of these
patients, and the results are normal. Idenix's primary concern is
patient safety and it will work diligently to expedite this review
process and continue its discussions with the FDA with the goal of
further advancing its drug candidates, IDX184 and IDX19368, in
clinical development.
ABOUT IDX19368
IDX19368 is an unpartnered liver-targeted nucleotide prodrug of
2'-methyl guanosine and was selected from a prodrug series of
approximately 350 compounds. It has shown high triphosphate levels
in vivo, with a low potential for drug-drug interactions.
In the third quarter of 2012, Idenix submitted an
investigational new drug (IND) application for IDX19368 with plans
to initiate clinical trials in the third quarter of 2012. However,
these clinical trials will not commence until the FDA removes the
clinical hold.
ABOUT IDX184
IDX184 is an unpartnered, novel, liver-targeted nucleotide
prodrug of 2'-methyl guanosine, which includes Idenix's proprietary
liver-targeting technology. This technology enables the delivery of
nucleoside monophosphate to the liver, leading to the formation of
high levels of nucleoside triphosphate, potentially maximizing drug
efficacy and limiting systemic side effects with low, once-daily
dosing.
In July 2012, an independent data safety monitoring board
reviewed the safety data for this study and confirmed that the side
effect profile of IDX184 combined with PegIFN/RBV is consistent
with that of PegIFN/RBV alone.
The FDA placed IDX184 on partial clinical hold as reported on
August 16, 2012. In previous clinical trials as well as the ongoing
phase IIb clinical trial of IDX184 in combination with pegylated
interferon and ribavirin (PegIFN/RBV), there has been no evidence
to date of cardiotoxicity in patients dosed with IDX184 with
PegIFN/RBV beyond that seen with PegIFN/RBV alone. There are
currently no patients receiving IDX184 worldwide.
ABOUT IDENIX
Idenix Pharmaceuticals, Inc., headquartered in Cambridge,
Massachusetts, is a biopharmaceutical company engaged in the
discovery and development of drugs for the treatment of human viral
diseases. Idenix's current focus is on the treatment of patients
with hepatitis C infection. For further information about Idenix,
please refer to www.idenix.com.
FORWARD-LOOKING STATEMENTS
This press release contains "forward-looking statements" for
purposes of the safe harbor provisions of The Private Securities
Litigation Reform Act of 1995, including but not limited to the
statements regarding the Company's development of drug candidates
and its future business performance. For this purpose, any
statements contained herein that are not statements of historical
fact may be deemed forward-looking statements. Without limiting the
foregoing, the words "expect," "plans," "anticipates," "intends,"
"will," and similar expressions are also intended to identify
forward-looking statements, as are expressed or implied statements
with respect to the Company's potential pipeline candidates,
including any expressed or implied statements regarding the
Company's ability to continue clinical development of IDX184 and
IDX19368, the efficacy and safety of IDX184 and IDX19368; the
likelihood and success of any future clinical trial
involving IDX184 and IDX19368 and the successful development
of these compounds. Actual results may differ materially from those
indicated by such forward-looking statements as a result of risks
and uncertainties, including but not limited to the following:
there can be no guarantees that the Company will advance any
clinical product candidate or other component of its potential
pipeline to the clinic, to the regulatory process or to
commercialization; management's expectations could be affected by
unexpected regulatory actions or delays; uncertainties relating to,
or unsuccessful results of, clinical trials, including additional
data relating to the ongoing clinical trials evaluating its product
candidates and clinical trials of compounds under development by
other companies; changes in the Company's business plan or
objectives; competition in general; and the Company's ability to
obtain, maintain and enforce patent and other intellectual property
protection for its product candidates and its discoveries. Such
forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause actual results to be
materially different from any future results, performance or
achievements expressed or implied by such statements. These and
other risks which may impact management's expectations are
described in greater detail under the heading "Risk Factors" in the
Company's annual report on Form 10-K for the year ended December
31, 2011 and the quarterly report on Form 10-Q for the quarter
ended June 30, 2012, each as filed with the Securities and Exchange
Commission (SEC) and in any subsequent periodic or current report
that the Company files with the SEC.
All forward-looking statements reflect the Company's estimates
only as of the date of this release (unless another date is
indicated) and should not be relied upon as reflecting the
Company's views, expectations or beliefs at any date subsequent to
the date of this release. While Idenix may elect to update these
forward-looking statements at some point in the future, it
specifically disclaims any obligation to do so, even if the
Company's estimates change.
CONTACT: Idenix Pharmaceuticals Contacts:
Kelly Barry (617) 995-9033 (media)
Daniella Beckman (617) 224-4471 (investors)
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