Idenix Pharmaceuticals Announces Initiation of Phase II All-Oral Combination Study of Samatasvir (IDX719) and Simeprevir (TMC43
May 30 2013 - 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 the initiation
of the phase II HELIX-1 clinical trial evaluating an all-oral,
direct-acting antiviral (DAA) HCV combination regimen of samatasvir
(IDX719), Idenix's once-daily pan-genotypic NS5A inhibitor, and
simeprevir (TMC435), a once-daily protease inhibitor jointly
developed by Janssen R&D Ireland and Medivir AB.
The HELIX-1 trial is a 12-week, randomized, double-blind,
parallel group study evaluating the safety and tolerability of
samatasvir and simeprevir in addition to antiviral activity
endpoints, with a target enrollment of 90 treatment-naïve,
non-cirrhotic, genotype 1b or 4 HCV-infected patients. Patients
will be randomized equally across three treatment arms, receiving
either 50, 100, or 150 mg samatasvir once-daily for 12 weeks in
combination with simeprevir plus ribavirin. The HELIX-1 trial is
the first study in HCV-infected patients to commence under a
non-exclusive collaboration agreement signed with Janssen in
January 2013. A second trial (HELIX-2) of samatasvir, simeprevir
and TMC647055, a once-daily non-nucleoside polymerase inhibitor
boosted with low-dose ritonavir being developed by Janssen, is
expected to initiate in the second half of 2013.
"We are pleased with the progress of our samatasvir program and
its advancement into phase II following successful completion of a
drug-drug interaction study with simeprevir earlier this year,"
said Ron Renaud, Idenix's President and Chief Executive Officer.
"Our goal is to initiate multiple two- and three-DAA trials of
samatasvir through the Janssen collaboration. Additionally, we look
forward to advancing our own internal combination of samatasvir
with our lead uridine nucleotide analog by the end of this
year."
ABOUT THE IDENIX/JANSSEN COLLABORATION
In January 2013, Idenix entered into a non-exclusive
collaboration with Janssen Pharmaceuticals, Inc. for the clinical
development of all-oral direct-acting antiviral (DAA) HCV
combination therapies. The collaboration will evaluate combinations
including samatasvir, simeprevir, and TMC647055. In addition
to the HELIX-1 phase II trial, the companies also plan to initiate
HELIX-2 which will evaluate a three-DAA combination of samatasvir,
simeprevir and TMC647055/r, with and without ribavirin. The
clinical trials will be 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 for up to 14
days duration and up to 100 mg in HCV-infected patients up to
3 days 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 (TMC435)
Simeprevir is a once-daily potent investigational hepatitis C
protease inhibitor in late phase III clinical development
being jointly developed by Janssen R&D Ireland and Medivir AB
to treat chronic hepatitis C virus infections. Simeprevir is
being investigated in combination with PegIFN/RBV in phase III
trials and is also being evaluated with direct-acting antiviral
(DAA) agents in three other phase II interferon-free combinations
both with and without ribavirin (RBV). For further details
please visit http://www.medivir.com.
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 virus (HCV) 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 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 IDX719 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; 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 quarterly report on Form
10-Q for the quarter ended March 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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