An all-oral combination phase II study of Simeprevir and Samatasvir (IDX719) for the treatment of hepatitis C virus infection initiated
· Phase II HELIX-1 trial is first hepatitis C clinical study to commence through collaboration agreement between Janssen Pharmaceuticals Inc. and Idenix Pharmaceuticals Inc.
30-May-13
Stockholm, Sweden — Medivir AB (OMX: MVIR) today announced that Idenix
Pharmaceuticals Inc. has initiated a phase II clinical trial, called
HELIX-1, evaluating an all-oral, direct-acting antiviral (DAA) HCV
combination regimen of simeprevir, a once-daily protease inhibitor
jointly developed by Medivir and Janssen R&D Ireland and samatasvir
(IDX719), Idenix’s once-daily pan-genotypic NS5A inhibitor.
“Hepatitis
C is a complex disease and there is a need for multiple treatment
options. Future hepatitis C treatment will be interferon free and will
consist of two to three direct acting antivirals (DAAs). We are pleased
and looking forward to having simeprevir evaluated in this
two-direct-acting antiviral phase II study”, said Charlotte Edenius, EVP
Development, Medivir AB.
About the HELIX trial
The HELIX-1
trial is a 12-week, randomized, double-blind, parallel group study
evaluating the safety and tolerability of simeprevir and samatasvir 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 50,
100, or 150 mg samatasvir once-daily for 12 weeks in combination with
150mg simeprevir plus ribavirin.
The HELIX-1 trial is the first
study in HCV-infected patients to commence under a non-exclusive
collaboration agreement signed between Janssen and Idenix in January
2013. A second trial (HELIX-2) of simeprevir, samatasvir and TMC647055, a
once-daily non-nucleoside polymerase inhibitor boosted with low-dose
ritonavir being developed by Janssen, is expected to commence in the
second half of 2013.
For more information please contact:
Rein Piir, EVP Corporate Affairs & IR
Mobile: +46 708 537 292
About Simeprevir
Simeprevir
is an investigational NS3/4A protease inhibitor jointly developed by
Medivir AB and Janssen R&D Ireland for the treatment of genotype 1
chronic hepatitis C in adult patients with compensated liver disease,
including all stages of liver fibrosis. Simeprevir works by blocking the
protease enzyme that enables the hepatitis C virus to replicate in host
cells.
New drug applications were recently submitted for
simeprevir in Japan and the United States for the treatment of genotype 1
hepatitis C, and a Marketing Authorisation Application was submitted to
the European Medicines Agency seeking approval of simeprevir for the
treatment of genotype 1 or genotype 4 chronic hepatitis C. The U.S. FDA
has granted Priority Review to the New Drug Application.
Global
phase III studies of simeprevir include PROMISE in adult patients who
have relapsed after prior interferon-based treatment, QUEST-1 and
QUEST-2 in treatment-naïve adult patients, and ATTAIN in prior
null-responder adult patients. In parallel to these trials, phase III
studies for simeprevir are ongoing in treatment-naïve and
treatment-experienced HIV-HCV co-infected patients and HCV genotype 4
patients.
Simeprevir is also being studied in phase II interferon-free trials with and without ribavirin in combination with:
· Janssen’s non-nucleoside inhibitor TMC647055 and ritonavir in treatment-naïve genotype 1a and 1b HCV patients;
· Gilead Sciences, Inc.’s nucleotide inhibitor sofosbuvir (GS-7977) in
treatment-naïve and previous null-responder genotype 1 HCV patients;
and
· Bristol-Myers Squibb's NS5A replication complex inhibitor
daclatasvir in treatment-naive and previous null-responder genotype 1
HCV patients.
In addition, Janssen Pharmaceuticals, Inc. has
entered into a non-exclusive collaboration with Vertex Pharmaceuticals
to evaluate in a phase II study the safety and efficacy of an all-oral
regimen of simeprevir and Vertex’s investigational nucleotide analogue
polymerase inhibitor VX-135 for the treatment of HCV. As a first step,
Janssen Pharmaceuticals, Inc. is conducting a drug-drug interaction
(DDI) study with simeprevir and VX-135.
For additional information about simeprevir clinical trials, please visit www.clinicaltrials.gov
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 for
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. For information about Idenix, please refer to www.idenix.com.
About Hepatitis C
Hepatitis
C, a blood-borne infectious disease of the liver and a leading cause of
chronic liver disease and liver transplants, is a rapidly evolving
treatment area with a clear need for innovative treatments.
Approximately 150 million people are infected with hepatitis C virus
worldwide, and about 350,000 people per year die from the disease. When
left untreated, hepatitis C can cause significant damage to the liver
including cirrhosis. Additionally, hepatitis C may increase the risk of
developing complications from cirrhosis, which may include liver
failure.
About Medivir
Medivir is an emerging research-based pharmaceutical company focused on infectious diseases.
Medivir
has world class expertise in polymerase and protease drug targets and
drug development which has resulted in a strong infectious disease
R&D portfolio. The Company’s key pipeline asset is simeprevir, a
novel protease inhibitor in late phase III clinical development for
hepatitis C that is being developed in collaboration with Janssen
R&D Ireland. Medivir has also a broad product portfolio with
prescription pharmaceuticals in the Nordics.
For more information about Medivir AB, please visit the Company’s website: www.medivir.com
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