CAMBRIDGE, Mass., Jan. 9, 2012 /PRNewswire/ -- 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 interim data from a
12-week phase IIb clinical trial of IDX184, the Company's lead
product candidate for the treatment of hepatitis C virus (HCV)
infection. IDX184, a pan-genotypic oral nucleotide polymerase
inhibitor, has demonstrated a high barrier to resistance in
vitro and potent antiviral activity in both preclinical and
clinical studies.
IDX184 Phase IIb Study Design
In July 2011, the Company
initiated enrollment of treatment-naive genotype 1 HCV-infected
patients into a randomized, double-blind, parallel group phase IIb
clinical trial of IDX184. The study features two treatment
arms, either 50 mg or 100 mg of IDX184 administered once-daily for
12 weeks, each arm in combination with pegylated interferon and
ribavirin (PegIFN/RBV). Study objectives include safety and
tolerability, and antiviral activity endpoints.
IDX184 Phase IIb Interim Study Results
The first 31 patients have completed 28 days of treatment,
and the interim data have shown that IDX184 was well-tolerated and
that there were no serious adverse events associated with therapy.
The side effect profile was consistent with that seen with
PegIFN/RBV. The independent DSMB has reviewed the data for the
first 31 patients and has recommended continuing enrollment of the
study. The Company has submitted the interim data, along with the
DSMB's recommendations, to the U.S. Food and Drug Administration
(FDA) and is requesting the continuation of this study and removal
of the partial clinical hold for IDX184.
RVR findings demonstrated that 73% of patients in the 100 mg
IDX184 arm (n=15) and 63% in the 50 mg arm (n=16) had undetectable
virus (LLOQ < 25 IU/ml) at 28 days. Currently 87% of patients in
the 100 mg arm and 94% in the 50 mg arm had undetectable virus at a
median of 8 weeks of treatment. There have been no virologic
breakthroughs observed in the study to date.
"These interim results are encouraging as they confirm the
antiviral activity and safety of IDX184 in combination with
pegylated interferon and ribavirin," Eric
Lawitz, M.D., of Alamo Medical Research, Camden Medical
Center, stated. "Nucleotide drugs such as IDX184 are becoming an
important component in the rapidly evolving treatment regimens for
HCV. Eventually, the goal for treatment will be to reduce or
eliminate reliance on interferon and to shift to all oral
combinations of direct-acting antiviral agents that can reduce
potential side effects and decrease the amount of time on
therapy."
Ron Renaud, President and Chief
Executive Officer of Idenix, commented, "We are very pleased with
the interim results for IDX184 and with the progress we made in
2011 across our programs. In 2012, we will build on this progress
and believe we are well positioned to play a major role in treating
HCV patients for the foreseeable future."
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. IDX184 is currently being developed under a
partial clinical hold.
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 40631574. 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 January 23, 2012, by dialing
(855) 859-2056 (U.S./Canada) or
(404) 537-3406 (International) and enter the passcode 40631574.
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 hepatitis C; the likelihood and success of any future clinical
trials involving our drug candidates; and expectations with respect
to funding of operations and future cash balances. 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; the Company's
ability to obtain additional funding required to conduct its
research, development and commercialization activities; the
Company's dependence on its collaboration with Novartis Pharma AG;
changes in the Company's business plan or objectives; the ability
of the Company to attract and retain qualified personnel;
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 quarterly report on Form 10-Q for the quarter ended
September 30, 2011, 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.
Idenix Pharmaceuticals Contacts:
Kelly Barry (617) 995-9033
(media)
Teri Dahlman (617) 995-9807
(investors)
SOURCE Idenix Pharmaceuticals, Inc.