Market Snapshot
  • U.S.
  • Europe
  • Asia
Ticker Volume Price Price Delta
DJIA 16,408.54 -16.31 -0.10%
S&P 500 1,864.85 2.54 0.14%
NASDAQ 4,095.52 9.29 0.23%
Ticker Volume Price Price Delta
STOXX 50 3,155.81 16.55 0.53%
FTSE 100 6,625.25 41.08 0.62%
DAX 9,409.71 91.89 0.99%
Ticker Volume Price Price Delta
NIKKEI 14,613.81 97.54 0.67%
TOPIX 1,179.15 5.78 0.49%
HANG SENG 22,760.24 64.23 0.28%

Idenix Pharmaceuticals Reports Sustained Virologic Response Rate (SVR4) for Phase II All-Oral Combination Study of Samatasvir



Idenix Pharmaceuticals Reports Sustained Virologic Response Rate (SVR4) for
Phase II All-Oral Combination Study of Samatasvir (IDX719), a Potent,
Pan-Genotypic HCV NS5A Inhibitor, and Simeprevir

CAMBRIDGE, Mass., Jan. 13, 2014 (GLOBE NEWSWIRE) -- 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      Samatasvir/Simeprevir Treatment Groups
Clinical Trial
                                  50 mg/150 mg   100 mg/150 mg  150 mg/150 mg
n                                 20             21             22*
Rapid Virologic Response (RVR);   20/20 (100%)   20/21 (95%)    18/19 (95%)
Measured after 4 weeks of                                        
treatment (LOQ)
End Of Treatment Response (EOT);  18/20 (90%)    19/21 (90%)    11/19 (58%)
Measured at end of 12-week                                       
treatment period (LOD)
Sustained Virologic Response
(SVR4);                           17/20 (85%)    16/21 (76%)    10/19 (53%)
Measured 4 weeks after end of                                    
treatment (LOD)
* 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 log[10] 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

Idenix Pharmaceuticals logo
Sponsored Links
Advertisement
Advertisements
Sponsored Links
Advertisement