Phase II HELIX-1 Trial is First HCV
Clinical Study to Commence Through Collaboration Agreement With Janssen
CAMBRIDGE, Mass., May 30, 2013 (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 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.
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.