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 interim data
from the Company's ongoing phase II 12-week 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, plus ribavirin. The combination regimen was
well-tolerated in the study. In the treatment-naïve, non-cirrhotic,
genotype 1b or 4 HCV-infected patients receiving 50 mg of
samatasvir and 150 mg of simeprevir plus ribavirin, 85 percent
(n=17/20) remained undetectable for HCV RNA four weeks after
completing therapy (SVR4). The 50 mg dose of samatasvir is the
selected dose in the ongoing 3-DAA HELIX-2 clinical trial. The
HELIX-1 study results are expected to be presented at a scientific
meeting in 2014.
"We are pleased with the progress of our program with Janssen,
including the announcement of the HELIX-1 SVR4 and safety data, as
well as the recent initiation of a second phase II all-oral
combination study, HELIX-2," stated Ron Renaud, President and Chief
Executive Officer of Idenix. "We also have successfully completed
the single-dose portion of the phase I/II clinical trial of
IDX21437, a next-generation uridine nucleotide prodrug inhibitor,
and the 7-day proof-of-concept portion of the study is underway.
Based on these important developments, we are on track to initiate
an Idenix-sponsored combination study of samatasvir and IDX21437 by
mid-2014."
HELIX-1 STUDY DESIGN
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. The HELIX-1 trial is a phase II 12-week,
randomized, parallel-group study evaluating the antiviral activity,
safety and tolerability of samatasvir and simeprevir in
treatment-naïve, non-cirrhotic, genotype 1b or 4 HCV-infected
patients. Patients in Part A of the study (n=63) were enrolled in
one of three treatment groups receiving 50, 100, or 150 mg
samatasvir once-daily for 12 weeks in combination with 150 mg of
simeprevir plus a weight-based dose of ribavirin. In Part B of the
ongoing HELIX-1 study, exploratory cohorts of patients have been
added to evaluate the safety and antiviral activity of simeprevir
and ribavirin in combination with 1) a 25 mg dose of samatasvir in
genotype 1b-infected patients and 2) a 100 mg dose of samatasvir in
genotype 6-infected patients.
A second phase II trial (HELIX-2) was initiated in December 2013
evaluating samatasvir, simeprevir and TMC647055, a once-daily
non-nucleoside polymerase inhibitor boosted with low-dose ritonavir
being developed by Janssen, with and without ribarivin in genotype
1-infected patients who are either treatment-naïve or have
previously relapsed after treatment with interferon and
ribavirin.
HELIX-1 INTERIM DATA
The combination treatment regimen has been well-tolerated, and
there have been no treatment-related serious adverse events in the
clinical trial to date. The most frequently reported adverse events
were fatigue, pruritus, anemia, nausea and insomnia.
Virologic response data from Part A of the HELIX-1 study are as
follows:
|
|
Phase II HELIX-1 Combination Clinical
Trial |
Samatasvir/Simeprevir
Treatment Groups |
|
50 mg/150 mg |
100 mg/150 mg |
150 mg/150 mg |
n |
20 |
21 |
22* |
Rapid Virologic Response (RVR);
Measured after 4 weeks of treatment (LOQ) |
20/20 (100%) |
20/21 (95%) |
18/19 (95%) |
End Of Treatment Response (EOT);
Measured at end of 12-week treatment period (LOD) |
18/20 (90%) |
19/21 (90%) |
11/19 (58%) |
Sustained Virologic Response (SVR4);
Measured 4 weeks after end of treatment (LOD) |
17/20 (85%) |
16/21 (76%) |
10/19 (53%) |
* Three subjects
prematurely discontinued treatment within the first 3 weeks (1 lost
to follow-up, 2 non-compliance) LOQ = limit of quantitation (<
25 IU/mL); LOD=limit of detection (<10 IU/mL) |
"The HELIX-1 study has supported our goal of building the safety
profile of samatasvir as part of an all-oral 12-week HCV
combination," said Douglas Mayers, M.D., Chief Medical Officer of
Idenix. "Based on these data, the 50 mg dose was selected to
be evaluated as part of the 3-DAA combination regimen in the
recently initiated HELIX-2 clinical trial."
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-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.
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 patients with compensated liver disease,
including cirrhosis.
Simeprevir was approved for the treatment of genotype 1
hepatitis C in September 2013 in Japan under the trade name
SOVRIAD™, in November 2013 in Canada under the trade name GALEXOS™
and in November 2013 in the United States under the trade name
OLYSIO™. 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 and genotype 4 chronic hepatitis C. To date, more
than 3,700 patients have been treated with simeprevir in clinical
trials.
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, (617) 995-9807
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