Idenix Announces Positive Clinical Data for HCV Drug Candidates IDX184 and IDX719
In an Interim Analysis From an Ongoing Phase IIb Clinical Trial of IDX184, an HCV Nucleotide Inhibitor, 89% of Patients Who Completed an Additional 12 Weeks of Pegylated Interferon Plus Ribavirin Treatment Achieved SVR4; 100% (4/4) in 100 mg Arm and 80% (4/5) in 50 mg Arm
IDX719, an HCV NS5A Inhibitor, Achieves Potent Pan-Genotypic Activity in Three-Day Proof-of-Concept Clinical Trial
CAMBRIDGE, Mass., June 19, 2012 (GLOBE NEWSWIRE) -- 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 results from an ongoing
phase IIb study of IDX184 in combination with pegylated interferon
and ribavirin (PegIFN/RBV). Of the first cohort of 31 patients
enrolled in the study, those who achieved an eRVR (n=18), defined
as having undetectable levels of virus at 4 weeks and 12 weeks,
were randomized to stop treatment after either an additional 12
weeks (n=9) or 36 weeks (n=9) of PegIFN/RBV. Of the nine patients
who completed their 12-week PegIFN/RBV extended treatment phase,
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).
Patients who did not achieve an eRVR automatically entered the
36-week PegIFN/RBV extended treatment phase which is ongoing. To
date, the side effect profile of IDX184 combined with PegIFN/RBV is
consistent with that of PegIFN/RBV alone.
"We are encouraged by the initial SVR results from the phase IIb program, which have confirmed previous data showing that IDX184 is a potent nucleotide inhibitor with a profile supporting its potential role as a key component of all-oral direct-acting antiviral (DAA) combination regimens for HCV," stated Ron Renaud, President and Chief Executive Officer of Idenix. "We look forward to initiating interferon-free DAA combination studies in the near term."
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 PegIFN/RBV.
Response-guided therapy was used to complete an additional 12 or 36
weeks of PegIFN/RBV treatment. Study objectives include safety and
tolerability, and antiviral activity endpoints.
IDX719 Proof-of-Concept Clinical Trial Data and Study Design
Idenix also announced today positive data from a three-day
proof-of-concept study evaluating IDX719, an NS5A inhibitor, in 64
treatment-naïve, genotype 1, 2, 3 or 4 HCV-infected
patients.
Genotype 1 patients were randomized to receive placebo, 25 mg QD
(once-daily), 50 mg QD, 50 mg BID (twice-daily) or 100 mg QD for
three days. Genotype 2, 3 or 4 patients were randomized to receive
placebo,
50 mg BID or 100 mg QD for three days.
IDX719 was well tolerated with no serious adverse events
reported.
Treatment with IDX719 exhibited potent pan-genotypic activity
across
genotypes:
-- In genotype 1 patients (n=28), mean maximal viral load
reductions were
3.2 log10 IU/mL in the 25 mg QD arm, 3.7 log10 IU/mL in the 50 mg
QD
arm, 3.2 log10 IU/mL in the 50 mg BID arm and 3.5 log10 IU/mL in
the 100
mg QD arm.
-- In genotype 2 patients (n=8), the mean maximal viral load
reduction was
2.0 log10 IU/mL in both the 50 mg BID and 100 mg QD dose arms with
a
greater variability in responses among these patients (range: 0.3
-- 4.1
log10 IU/mL). The company is currently conducting pharmacokinetic
and
sequencing analyses to further characterize these results.
-- In genotype 3 patients (n=8), mean maximal viral load reductions
were
3.3 log10 IU/mL in the 50 mg BID arm and 3.4 log10 IU/mL in the 100
mg
QD arm.
-- In genotype 4 patients (n=7), mean maximal viral load reductions
were
3.9 log10 IU/mL in the 50 mg BID dose arm and 3.4 log10 IU/mL in
the 100
mg QD dose arm.
More detailed findings are expected to be presented at a scientific
meeting in the second half of 2012.
"We are pleased to demonstrate the first clinical validation of IDX719 in patients in a multiple-dose study with robust activity across multiple HCV genotypes," commented Douglas Mayers, M.D., Chief Medical Officer of Idenix. "Given these promising findings, we look forward to initiating a phase II combination study of IDX719 with IDX184 by the end of this year."
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 the ongoing phase IIb clinical trial, IDX184 has been well tolerated with a side effect profile similar to that of PegIFN/RBV. In the first cohort of 31 patients, at 12 weeks in an intent-to-treat analysis, the complete early virologic response (< 25 IU/mL at 12 weeks) was 93% for the 100 mg IDX184 arm (n=15) and 81% for the 50 mg IDX184 arm (n=16) of the study. The company completed enrollment of a second cohort of 36 additional patients in May 2012.
ABOUT IDX719
IDX719 is an NS5A inhibitor with low picomolar, pan-genotypic antiviral activity in vitro. In 36 healthy volunteers, IDX719 was safe and well tolerated at single doses of 5-100 mg as well as multiple doses of 100 mg for 7 days. Single doses of IDX719 demonstrated potent pan-genotypic antiviral activity in 18 genotype 1, 2 or 3 HCV-infected patients, with greater than 3 log10 viral load reductions achieved in the 100 mg dose arm.
ABOUT HEPATITIS C
Hepatitis C virus is a common blood-borne pathogen infecting
three to four million people worldwide annually. The World Health
Organization
(WHO) estimates that more than 170 million people worldwide are
chronically infected with HCV, representing a nearly 5-fold greater
prevalence than human immunodeficiency virus.
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 HCV.
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 IDX719 or any other drug
candidate; the successful development of novel combinations of
direct-acting antivirals for the treatment of HCV; the likelihood
and success of any future clinical trials involving our drug
candidates; and expectations with respect to future milestone or
royalty payments, 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; 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 annual report on Form 10-K for the year ended December
31, 2011 and quarterly report on Form 10-Q for the quarter ended
March 31, 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)
Teri Dahlman (617) 995-9807 (investors)
Posted: June 2012
