Idenix Pharmaceuticals Announces Initiation of Enrollment in a Phase II All-Oral Combination Study of Samatasvir (IDX719), Si...
December 02 2013 - 6:00AM
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 the initiation
of patient enrollment in the phase II HELIX-2 clinical trial
evaluating an all-oral, direct-acting antiviral (DAA) HCV
combination regimen of samatasvir, Idenix's once-daily
pan-genotypic NS5A inhibitor, simeprevir, a once-daily NS3/4A
protease inhibitor jointly developed by Janssen R&D Ireland and
Medivir AB, and TMC647055, a once-daily NS5B non-nucleoside
polymerase inhibitor boosted with low-dose ritonavir developed by
Janssen.
The HELIX-2 trial is a 12-week, randomized, open-label study
evaluating the efficacy, safety and tolerability of samatasvir,
simeprevir, and TMC647055. The trial will evaluate genotype 1
HCV-infected patients who are either treatment-naïve or who have
relapsed after prior treatment with interferon and ribavirin.
Patients will receive 50 mg samatasvir, 75 mg of simeprevir and 450
mg of TMC647055/ritonavir (30 mg), each once daily for 12 weeks,
with or without ribavirin.
The HELIX-2 trial is the second study in HCV-infected patients
to commence under a non-exclusive collaboration agreement signed
with Janssen in January 2013. The HELIX-1 trial of samatasvir in
combination with simeprevir was initiated in May 2013 and is
ongoing.
"We are pleased with the continuing progress of our clinical
program for samatasvir, which will provide additional important
information on the use of this promising compound as part of
all-oral HCV combination regimens," said Doug Mayers, M.D.,
Idenix's Chief Medical Officer. "With the advancement of the
samatasvir program as well as that of our novel nucleotide prodrug
inhibitor, IDX21437, we anticipate initiating the evaluation of our
own HCV combination regimen in 2014."
ABOUT THE IDENIX/JANSSEN COLLABORATION
In January 2013, Idenix entered into a non-exclusive
collaboration with Janssen Pharmaceuticals for the clinical
development of all-oral direct-acting antiviral (DAA) HCV
combination therapies. The collaboration is evaluating
combinations including samatasvir, simeprevir, and TMC647055.
The HELIX-1 and HELIX-2 clinical trials are being conducted
by Idenix. Both Idenix and Janssen retain all rights to their
respective compounds under the agreement.
ABOUT SAMATASVIR (IDX719)
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-emergent 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.
ABOUT SIMEPREVIR
Simeprevir is an NS3/4A protease inhibitor jointly developed by
Janssen R&D Ireland and Medivir AB for the treatment of chronic
hepatitis C infection in combination with other antivirals in HCV
genotype 1- and 4-infected subjects with compensated liver disease,
including cirrhosis.
Simeprevir was approved for the treatment of genotype 1
hepatitis C in September 2013 in Japan, in November 2013 in Canada
and in November 2013 in the United States. A Marketing
Authorisation Application was submitted to the European Medicines
Agency (EMA) in April 2013 by Janssen-Cilag International NV
seeking approval of simeprevir for the treatment of genotype 1 or
genotype 4 chronic hepatitis C. To date, more than 3,700 patients
have been treated with simeprevir in clinical trials. For further
details please visit http://www.medivir.com.
ABOUT TMC647055
TMC647055 is a potent non-nucleoside hepatitis C polymerase
inhibitor with broad genotypic coverage. TMC647055 is in phase II
clinical development and is developed by Janssen R&D Ireland to
treat chronic hepatitis C virus infections. TMC647055 is being
investigated in combination with other DAA agents in all oral
interferon-free regimens. There have been no treatment-emergent
serious adverse events reported in the program.
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 samatasvir 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
samatasvir, IDX21437 or our other drug candidates; and expectations
with respect to 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 expectations regarding the benefits of
the restructuring of 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, 2012 and the quarterly report on
Form 10-Q for the quarter ended September 30, 2013, 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 Contact:
Teri Dahlman, Dahlman.Teresa@idenix.com
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