Phase II HELIX-2 Trial is the Second HCV Clinical Study to Commence
Under Collaboration Agreement With Janssen Pharmaceuticals, Inc.
CAMBRIDGE, Mass., Dec. 2, 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 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.
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.
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
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.
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.