Idenix Reports Favorable Resistance Profile for IDX719, a Potent, Pan-Genotypic HCV NS5A Inhibitor, at EASL Meeting
24 April 2013 - 10:00PM
Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), a biopharmaceutical
company engaged in the discovery and development of drugs for the
treatment of human viral diseases, today reported detailed
resistance data from in vitro studies and from a three-day
monotherapy clinical trial of IDX719, the Company's once-daily,
potent, pan-genotypic NS5A inhibitor for the treatment of hepatitis
C virus (HCV) infection. These data are being presented on
Saturday, April 27, in a poster session at the 48th Annual Meeting
of the European Association for the Study of the Liver (EASL),
which is being held April 24 - 28, 2013 in Amsterdam, The
Netherlands.
Data from the three-day proof-of-concept study 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.
These data were supported by earlier in vitro findings. Clinical
plasma samples at baseline, at end of treatment and at one week
post-treatment were sequenced for mutations in NS5A at known IDX719
resistance-associated locations.
- The most common treatment-emergent resistant mutations were
detected at NS5A positions 28, 31 and 93. The profile of these
mutations varied among genotypes.
- The only resistance mutation present at baseline found to
negatively affect IDX719 response was M31 in GT2-infected patients.
In contrast, all GT4-infected patients had virus with M31 at
baseline and responded favorably to IDX719 treatment.
- A GT1b-infected patient with a baseline Y93H mutation, which
confers in vitro resistance to IDX719, achieved a 2.79 log10 IU/mL
viral load reduction after three days of once-daily 25 mg IDX719,
indicating that IDX719 can retain activity against virus with known
resistance mutations.
The poster presentation is titled, "Treatment-Emergent Variants
Following 3 Days of Monotherapy with IDX719, a Potent,
Pan-Genotypic NS5A Inhibitor, in Subjects Infected with HCV
Genotypes 1-4" (Abstract No. 1209).
"These additional resistance data support the promising profile
of IDX719 as a potent, pan-genotypic component of future HCV
combination treatment regimens," commented Douglas Mayers, M.D.,
Chief Medical Officer of Idenix. "We look forward to evaluating
IDX719 as part of all-oral combination therapies through our
collaboration with Janssen, beginning with the initiation of a
phase II clinical trial of IDX719 and simeprevir in the first half
of this year."
ABOUT IDX719
IDX719 is an NS5A inhibitor with low picomolar, pan-genotypic
antiviral activity in vitro. To date, IDX719 has been safe and
well tolerated after single and multiple doses of up to 100 mg in
healthy volunteers (n=36; up to 7 days duration) and HCV-infected
patients (n=69; up to 3 days duration). There have been no
treatment-emergent serious adverse events reported in the program.
IDX719 has demonstrated potent pan-genotypic antiviral activity in
HCV-infected patients with mean maximal viral load reductions up to
approximately 4.0 log10 IU/mL across HCV genotypes 1-4 in a
proof-of-concept, three-day monotherapy 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 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. 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 any expressed or implied statements with respect
to: the Company's plans to continue to developing nucleotide
polymerase inhibitors for HCV; its clinical development plans for
its uridine nucleotide analog drug candidate and IDX719; its plans
to advance other preclinical nucleotides; and statements regarding
the efficacy and safety of its clinical compounds. 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 due to numerous risks
inherent in pharmaceutical research and development; management's
expectations could be affected by unexpected regulatory actions or
delays; uncertainties relating to, or unsuccessful results of,
preclinical and 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; 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
important 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, 2012, 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 Contact:
Teri Dahlman (617) 218-7987
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