Idenix Announces Nucleotide Prodrug (IDX21437) and NS5A Inhibitor (Samatasvir) Poster Presentations at 49th Annual Meeting of...
March 24 2014 - 8:00AM
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 three poster
presentations featuring clinical and preclinical data for the
Company's nucleotide prodrug, IDX21437, and for samatasvir,
Idenix's once-daily pan-genotypic NS5A inhibitor, at The
International Liver Congress™ 2014, the 49th annual meeting of the
European Association for the Study of the Liver (EASL), taking
place in London, April 9-13, 2014. Full abstracts can now be viewed
at the EASL Congress website.
The following abstracts will be presented in poster sessions
during The International Liver Congress™ 2014 on Saturday, April
12, 2014, 9:00 am – 6:00 pm BST:
- Poster No. 1244: Gupta et al. "Favorable Preclinical Profile of
IDX21437, a Novel Uridine Nucleotide Prodrug, for Use in a
Direct-Acting Antiviral (DAA) Regimen for HCV."
- Poster No. 1221: Zhou et al. "Pharmacokinetic (PK) Drug-Drug
Interaction between Samatasvir (IDX719), a Pan-Genotypic NS5A
Inhibitor, and Simeprevir in Healthy Volunteers and HCV-Infected
Subjects."
- Poster No. 1222: Lawitz et al. "A Phase II Study of Samatasvir
(IDX719) in Combination with Simeprevir and Ribavirin in
Treatment-Naïve HCV-Infected Subjects with Genotypes 1b and 4
(HELIX-1 Study)."
ABOUT IDX21437
IDX21437, a next-generation uridine nucleotide prodrug
inhibitor, has completed the single-dose portion of a phase I/II
clinical trial and is currently being evaluated in the seven-day
proof-of-concept portion of the trial, with results expected in the
first half of 2014. Extensive preclinical testing for IDX21437 has
demonstrated favorable antiviral activity across genotypes 1-6 and
a safety profile which supported advancement into clinical trials.
Based on this progress, the Company's goal is to initiate an
Idenix-sponsored combination clinical trial of IDX21437 and
samatasvir in mid-2014.
ABOUT SAMATASVIR
Samatasvir is an NS5A inhibitor with low picomolar,
pan-genotypic antiviral activity in vitro. To date, samatasvir has
been safe and well-tolerated after single and multiple doses of up
to 150 mg in healthy volunteers up to 14 days duration, and in
HCV-infected patients up to 12 weeks duration. There have been no
treatment-related serious adverse events reported in the program.
Samatasvir 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.
Under a non-exclusive collaboration with Janssen
Pharmaceuticals, Inc., Idenix is evaluating all-oral, direct-acting
antiviral HCV combination regimens including samatasvir, simeprevir
(TMC435), a once-daily protease inhibitor jointly developed by
Janssen R&D Ireland and Medivir AB, and TMC647055/r, a
once-daily non-nucleoside polymerase inhibitor boosted with
low-dose ritonavir being developed by Janssen. In this program,
Idenix is conducting two ongoing phase II 12-week clinical trials,
HELIX-1 and HELIX-2.
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 150 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 IDX21437,
samatasvir or any other drug candidate; the successful development
of novel combinations of direct-acting antivirals for the treatment
of HCV; and the likelihood and success of any future clinical
trials involving samatasvir, IDX21437or our other drug candidates.
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;
uncertainties relating to, or unsuccessful results of, clinical
trials, including additional data relating to the ongoing clinical
trials evaluating its product candidates; 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, 2013 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) 995-9807
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