Idenix Provides Update on IDX184 Clinical Development Program
August 16 2012 - 7:00AM
IDX184 has been placed on partial
clinical hold by FDA
Management to host a conference call
webcast today at 8:30 am ET
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 partial clinical hold has been placed on IDX184, the
Company's nucleotide polymerase inhibitor under development for the
treatment of hepatitis C virus (HCV).
As a result of the recent occurrence of a serious
cardiac-related adverse event encountered with a competitor's
nucleotide polymerase inhibitor for the treatment of HCV, the FDA
has expressed an interest in further reviewing the safety of IDX184
and has placed IDX184 on partial clinical hold. 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.
The FDA has requested additional data on patients treated with
IDX184. Patient safety is our main concern and Idenix will
immediately begin work to comply with the FDA request and expects
to submit these data to the FDA in the coming weeks. The Company
intends to have an ongoing discussion with the FDA following the
submission of this data.
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. The Company reported interim data in June 2012 for the
first cohort of 31 patients from an ongoing phase IIb clinical
trial of IDX184 in combination with PegIFN/RBV. Of the patients who
achieved an extended rapid virologic response (undetectable levels
of virus at 4 weeks and 12 weeks) and completed an additional 12
weeks of PegIFN/RBV (n=9), 100% of patients (4/4) in the 100 mg arm
and 80% of patients (4/5) in the 50 mg arm achieved a sustained
virologic response four weeks after the completion of treatment
(SVR4).
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.
ABOUT PARTIAL CLINICAL HOLD
A partial clinical hold is a delay or suspension of only part of
the clinical work requested under the investigational new drug
(IND) application (e.g., a specific protocol or part of a protocol
is not allowed to proceed; however, other protocols or parts of the
protocol are allowed to proceed under the IND). Under the partial
clinical hold, Idenix cannot enroll patients into additional
clinical trials until agreement is reached with the FDA on the next
clinical trial design.
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.
CONFERENCE CALL AND WEBCAST INFORMATION
Idenix will hold a conference call today at 8:30 a.m. ET. To
access the call, please dial (877) 640-9809 (U.S./Canada) or (914)
495-8528 (International) and enter passcode 22005490. A slide
presentation will accompany the conference call and can be accessed
on the Investor section of the Idenix website at www.idenix.com.
Please log on approximately 10 minutes prior to the start of the
call to ensure adequate time for any downloads that may be
necessary.
A replay of the conference call and webcast will be available
until August 27, 2012, by dialing (855) 859-2056 (U.S./Canada) or
(404) 537-3406 (International) and enter the passcode 22005490.
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 future business and financial
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 efficacy and safety of IDX184 or any other
drug candidate; the successful development of novel combinations of
direct-acting antivirals for the treatment of HCV; and the
likelihood and success of any future clinical trials involving
IDX184 or our other drug candidates. 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; 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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