Idenix Pharmaceuticals Reports Clinical Data for HCV Drug Candidates - IDX719 and IDX184 - at the American Association for the
November 10 2012 - 9:05AM
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 the presentation
of safety and antiviral activity results for the Company's
clinical-stage hepatitis C virus (HCV) drug candidates – IDX719, a
next-generation pan-genotypic NS5A inhibitor, and IDX184, a
nucleotide polymerase inhibitor. Idenix presented updated clinical
findings from a three-day proof-of-concept study, which
demonstrated that IDX719 was well-tolerated at daily doses up to
100 mg and showed potent antiviral activity across HCV genotypes
1-4, with mean maximal viral load reductions up to approximately
4.0 log10 IU/mL. The Company also presented updated cardiovascular
safety and antiviral activity data from the phase IIb study of
IDX184 in combination with pegylated interferon and ribavirin
(PegIFN/RBV). The IDX719 and IDX184 clinical data are being
reported in poster presentations during the 63rd Annual Meeting for
the American Association for the Study of Liver Diseases (AASLD) in
Boston.
IDX719 three-day proof-of-concept study
Study design
The three-day proof-of-concept study evaluated IDX719 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.
Study results
- In genotype 1a patients (n=29), mean maximal viral load
reductions ranged from 3.2 log10 IU/mL to 3.6 log10 IU/mL across
treatment groups.
- In genotype 1b patients (n=5), mean maximal viral load
reductions were 3.0 log10 IU/mL in the 25 mg QD arm, and 4.3 log10
IU/mL in the 50 mg QD arm.
- In genotype 2 patients (n=10), 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). Four of the genotype
2 patients responded well to IDX719 treatment, and four patients
had maximal reductions that were less than 1.0 log10 IU/mL. The
decrease in viral load response in genotype 2 patients was
associated with the pre-existence or emergence of the M31
polymorphism in the HCV NS5A gene.
- In genotype 3 patients (n=10), 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=10), mean maximal viral load
reductions were 3.9 log10 IU/mL in the 50 mg BID dose arm and 3.6
log10 IU/mL in the 100 mg QD dose arm.
No patients experienced a rebound (> 1.0 log10 IU/mL increase
over the lowest viral load) during the treatment period and maximum
viral load reductions were typically achieved within 24-72 hours
post dose. There were no safety-related discontinuations or serious
adverse events. IDX719 was safe and well tolerated at daily doses
up to 100 mg for three days. Idenix intends to initiate a
phase II clinical trial evaluating IDX719 in combination therapy in
2013.
"To our knowledge, these are the most advanced clinical results
validating the robust, pan-genotypic activity of an NS5A inhibitor
in HCV," commented Douglas Mayers, M.D., Chief Medical Officer of
Idenix. "We look forward to advancing this promising drug candidate
into the next phase of clinical testing."
IDX184 phase IIb combination study
Study design
A randomized, double-blind phase IIb clinical trial is
evaluating IDX184 in 67 treatment-naive genotype 1 HCV-infected
patients. 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 is used to
complete an additional 12 or 36 weeks of PegIFN/RBV treatment.
Study results
All patients had completed treatment with IDX184 when in August
2012, the U.S. Food and Drug Administration (FDA) placed IDX184 on
partial clinical hold due to cardiac adverse events seen in a
competitor's phase II clinical trial evaluating BMS-986094. The
overall safety profile of IDX184 in combination with PegIFN/RBV
remains consistent with the known safety profile of PegIFN/RBV
alone. In light of the clinical hold, Idenix has evaluated multiple
cardiac safety measurements, including electrocardiograms,
echocardiograms and two cardiac biomarkers, ultrasensitive
troponins and NT-proBNPs, from the ongoing IDX184 phase IIb study
and has found no evidence of severe cardiac findings to date.
Similar numbers of patients achieved a complete early virologic
response (cEVR; virus levels < 25 IU/mL at 12 weeks) in the 50
mg (26/34; 76%) and in the 100 mg (27/33; 82%) groups. Rates of
rapid virologic response (RVR; virus levels < 25 IU/mL at 4
weeks) were also comparable between the 50 mg (18/34; 53%) and the
100 mg (18/33; 55%) groups. The difference in response rates from
data previously reported is primarily due to an increased number of
genotype 1b patients as well as IL28B CT/TT patients who were
enrolled in the second patient cohort. No patient experienced
virologic breakthrough during the 12-week IDX184/Peg-IFN/RBV
treatment period. The majority of patients are in the ongoing
PegIFN/RBV extension treatment phase, and complete sustained
virologic response (SVR) results will be available in 2013.
"The IDX184 presentation at AASLD details much of the key
clinical data we intend to submit to the FDA in our response
package by the end of the year," said Ron Renaud, Idenix's
President and Chief Executive Officer. "As always, patient safety
is our top priority, and I am pleased with the thoroughness with
which our R&D team and the trial investigators have gathered
this information and that there have been no treatment-emergent
cardiac or renal serious adverse events (SAEs) to date in the
ongoing IDX184 study."
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 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 and IDX719;
and the likelihood and success of any future clinical trials
involving IDX184 or IDX719. 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; 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 September 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)
Teri Dahlman (617) 995-9807 (investors)
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