Idenix Pharmaceuticals Presents Data on IDX184 for the Treatment of Hepatitis C Virus (HCV)
CAMBRIDGE, Mass., Oct. 30 /PRNewswire-FirstCall/ -- 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 presentations of data on
IDX184, a once-daily novel liver-targeted nucleotide prodrug of
2'-methyl guanosine (2'MeG) for the treatment of HCV, at the annual
meeting of the American Association for the Study of Liver Diseases
(AASLD) currently being held in Boston, Massachusetts.
Data from a three-day, phase I proof-of-concept study evaluating
the safety and antiviral activity of IDX184 will be presented. This
double-blind, placebo-controlled, monotherapy, dose-escalation
study enrolled 41 treatment-naive HCV genotype 1-infected patients
into four dosing cohorts (25 mg, 50 mg, 75 mg and 100 mg). IDX184
was well tolerated in this study with no serious adverse events
reported and no discontinuations from the study. Patterns of
adverse events (AEs) were similar between IDX184- and
placebo-treated patients with the most frequent AEs being headache,
diarrhea and dizziness. Mean viral load declines ranged from 0.47
log10 in the 25 mg group to 0.74 log10 in the 100 mg group after
three days of treatment. In the 75 and 100 mg/day cohorts, patients
receiving IDX184 experienced improvements in two key markers of
liver injury (AST and ALT), with mean levels of these enzymes
decreasing to within normal range. Pharmacokinetic data
demonstrated that higher plasma levels of 2'MeG were associated
with greater reductions in viral load and ALT levels.
"With favorable safety data and good antiviral activity for
IDX184 in HCV patients, these early results are encouraging," said
Dr. Jacob Lalezari, principal investigator in the study, Director
of Quest Clinical Research and an Assistant Clinical Professor of
Medicine at UCSF/Mount Zion Hospital. "Nucleotides may become an
essential component of future STAT-C combinations for the treatment
of hepatitis C. IDX184 has shown a promising early profile and
should be evaluated in longer-term, combination trials."
Results will also be presented from in vitro studies evaluating
the combination of IDX184 with other direct-acting antivirals or
standard-of-care agents, interferon and ribavirin. These in vitro
studies suggest that when IDX184 is combined with compounds from
different classes, the antiviral activity may be enhanced, and in
some combinations, synergistic. Specifically, the triple
combination of IDX184, interferon and ribavirin showed strong
synergy in vitro. These in vitro studies also suggest that the
combination of IDX184 with other compounds from different classes
may suppress the emergence of resistance.
"The in vitro combination data for IDX184 are promising," said
David Standring, executive vice president of biology for Idenix.
"We look forward to assessing this potential synergy in the next
clinical study evaluating IDX184 in combination with pegylated
interferon and ribavirin in HCV genotype 1-infected
patients."
About IDX184
IDX184 is a 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 infections
caused by hepatitis C virus. For further information about Idenix,
please refer to www.idenix.com.
Forward-looking Statements
This press release contains "forward-looking statements" within
the meaning of The Private Securities Litigation Reform Act of
1995. Such forward-looking statements can be identified by the use
of forward-looking terminology such as "expect," "plans,"
"anticipates," "will," "expects," "goal" or similar expressions, or
by express or implied statements with respect to the company's
clinical development programs or commercialization activities in
hepatitis C, or any potential pipeline candidates, including any
expressed or implied statements regarding the efficacy and safety
of IDX184, the likelihood and success of any future clinical trials
involving IDX184 or successful development of novel combinations of
direct-acting antivirals for the treatment of hepatitis C. 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. 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. In
particular, 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; 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. These
and other risks which may impact management's expectations are
described in greater detail under the caption "Risk Factors" in the
company's annual report on Form 10-K for the year ended December
31, 2008 and the Quarterly Report on Form 10-Q for the quarter
ended September 30, 2009, as filed with the Securities and Exchange
Commission (SEC) and other filings that the company makes with the
SEC.
All forward-looking statements reflect the company's
expectations only as of the date of this release 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. Idenix
anticipates that subsequent events and developments may cause these
views, expectations and beliefs to change. However, while Idenix
may elect to update these forward-looking statements at some point
in the future, it specifically disclaims any obligation to do
so.
Idenix Pharmaceuticals Contact:
Teri Dahlman (617) 995-9905
Source: Idenix Pharmaceuticals, Inc.
CONTACT: Teri Dahlman of Idenix Pharmaceuticals,
+1-617-995-9905
Web Site: http://www.idenix.com/
Posted: October 2009
