CAMBRIDGE, Mass., Feb. 3, 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 that it has received
notification from the U.S. Food and Drug Administration (FDA) that
the partial clinical hold on IDX184 has been removed and that the
Company's 12-week phase IIb study evaluating IDX184 in combination
with pegylated interferon and ribavirin (PegIFN/RBV) may continue.
IDX184, the Company's lead product candidate for the treatment of
hepatitis C virus (HCV) infection is a pan-genotypic oral
nucleotide polymerase inhibitor, and has demonstrated a high
barrier to resistance in vitro and potent antiviral activity
in both preclinical and clinical studies. Recently announced
interim phase IIb data demonstrated favorable antiviral activity
and no serious adverse events.
"After review of the interim safety and antiviral activity
results from the IDX184 phase IIb clinical trial, the FDA removed
the partial clinical hold and has allowed us to continue enrollment
of this study," Ron Renaud,
President and Chief Executive Officer of Idenix, commented.
"Importantly, this allows us to expand the phase IIb program and
evaluate IDX184 in interferon-free combination regimens with other
direct-acting antivirals. We are working toward beginning all-oral
combination trials as quickly as possible."
About IDX184 Phase IIb Study
In July 2011, Idenix 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 PegIFN/RBV. Study objectives include safety and
tolerability, and antiviral activity endpoints. The FDA has agreed
to truncate the study from 100 patients, as in the original
protocol, to a total of 60 patients, and to expand the enrollment
criteria.
About IDX184 Partial Clinical Hold
A clinical hold originally was issued in September 2010 as a result of three cases of
elevated liver function tests observed during a drug-drug
interaction study in healthy volunteers of the combination of
IDX184 and IDX320, an investigational HCV protease inhibitor.
Idenix reviewed available data and conducted additional preclinical
studies. With the help of independent experts and an external
safety committee, the Company concluded that the observed toxicity
was likely caused by IDX320 and submitted all data to the FDA. At
the beginning of 2011, the FDA removed a full clinical hold on
IDX184, and the program was placed on partial clinical hold
allowing the Company to initiate the 12-week phase IIb study for
IDX184 in July 2011. In January 2012, Idenix submitted interim phase IIb
data for the first 31 patients to the FDA, along with a
recommendation from the independent Data Safety Monitoring Board to
continue the study, and requested removal of the partial clinical
hold on IDX184. The partial clinical hold has now been removed
allowing the initiation of dosing of an additional 30 patients in
the ongoing phase IIb clinical trial and the initiation of a broad
phase IIb program with IDX184 in the coming months.
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.
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 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.