Medivir Announces Plans for a Phase II All-oral Study of Simeprevir (TMC435) and VX-135 for the Treatment of Hepatitis C to be Conducted by Janssen and Vertex
STOCKHOLM, November 1, 2012 /PRNewswire/ –
- Companies to evaluate a two-drug combination of Medivir/Janssen's investigational protease inhibitor simeprevir (TMC435) and Vertex's investigational nucleotide analogue VX-135 - Phase II proof-of-concept study to begin in early 2013 to evaluate safety, tolerability and viral cure rates of 12-week treatment regimen
Medivir AB (OMX: MVIR), announced today plans for a phase II proof-of-concept study of
an all-oral regimen for the treatment of hepatitis C containing of Medivir/Janssen’s
protease inhibitor simeprevir and Vertex’s nucleotide analogue hepatitis C virus (HCV)
polymerase inhibitor VX-135. Janssen will conduct a drug-drug interaction study with
simeprevir and VX-135 to support the planned initiation of a phase II proof-of-concept
study in early 2013, pending discussions with regulatory authorities.
The phase II study is expected to evaluate safety, tolerability and viral cure rates
using a 12-week combination of simeprevir and VX-135, with and without ribavirin. Janssen
and Vertex will jointly fund development costs associated with the collaboration. There
are no up-front or milestone payments associated with the agreement.
Simeprevir is a potent, once-daily investigational hepatitis C protease inhibitor,
currently in phase III trials, being jointly developed by Medivir AB and Janssen R&D
Ireland. VX-135 is an investigational uridine nucleotide analogue pro-drug designed to
inhibit the replication of the hepatitis C virus by acting on the NS5B polymerase.
“This study will broaden our understanding of simeprevir, which we believe has the
necessary characteristics to become a key component of future hepatitis C treatment
regimens, including combination with interferon and ribavirin as well as interferon-free
therapies and is in line with Medivir’s and Janssen’s strategy to evaluate different
interferon-free HCV treatment possibilities” comments Charlotte Edenius, EVP of Research
and Development, Medivir AB.
Clinical development plans
Vertex and Janssen expect to initiate a phase II proof-of-concept study of VX-135 and
simeprevir in early 2013, following the completion of a drug-drug interaction (DDI) study.
Costs associated with the studies will be shared equally between the two companies. The
goals of the study will be to evaluate safety, tolerability and viral cure rates of
multiple 12-week combination regimens (SVR12*) of VX-135 and simeprevir, with and without
ribavirin. The study will include patients who have chronic non-cirrhotic genotype 1
hepatitis C and have not previously been treated (treatment-naive). Additional information
on the phase II study will be provided upon initiation of the study.
* SVR12 = undetectable hepatitis C virus 12 weeks after the end of treatment.
About Simeprevir (TMC435)
Simeprevir is a once-daily potent investigational hepatitis C protease inhibitor in
late phase III clinical development being jointly developed by Medivir AB and Janssen R&D
Ireland 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).
Global phase III studies of simeprevir include QUEST-1 and QUEST-2 in treatment naive
patients, PROMISE in patients who have relapsed after prior IFN-based treatment and ATTAIN
in treatment experienced patients. In parallel to these trials, phase III studies for
simeprevir are ongoing in both treatment naive and treatment experienced HIV-HCV
co-infected patients, HCV genotype 4 infected patients and in Japanese HCV genotype 1
The phase II interferon-free combinations both with and without ribavirin with
- Simeprevir is evaluated in combination with Gilead Science, sofosbuvir (GS7977) in null responder hepatitis C genotype 1 infected patients. - Simeprevir is evaluated in combination wtih BMS, daclatasvir in treatment-naive or previous null responder hepatitis C genotype 1 infected patients. - Simeprevir is evaluated in combination with TMC647055 (Janssen R&D) and ritonavir in low doses in treatment-naive, relapser or null responder hepatitis C genotype 1 infected patients.
For additional information about simeprevir please see
VX-135 (ALS-2200) is a uridine nucleotide analogue pro-drug that appears to have a
high barrier to drug resistance based on in vitro studies. It is designed to inhibit the
replication of the hepatitis C virus by acting on the NS5B polymerase. In vitro studies of
the compound showed antiviral activity across all genotypes, or forms, of the hepatitis C
virus, including genotypes more prevalent outside of the United States.
Earlier this year, Vertex announced the first 7-day viral kinetic data for VX-135.
Based on these data, the company plans to initiate multiple all-oral, phase II
proof-of-concept studies, including a study of VX-135 and ribavirin and a study of VX-135
and telaprevir, the company’s approved protease inhibitor marketed as INCIVEK for people
with chronic genotype 1 hepatitis C. Vertex is on track to initiate the study of VX-135 in
combination with ribavirin by the end of 2012, followed by the study with telaprevir in
early 2013. The studies will evaluate safety, tolerability and viral cure rates of 12-week
combination regimens in people with chronic non-cirrhotic genotype 1 hepatitis C who have
not previously been treated (treatment-naive).
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of
chronic liver disease and liver transplants. The World Health Organization estimates that
nearly 170 million people worldwide, approximately 3% of the world’s population, are
infected with hepatitis C virus (HCV). The CDC (Centers for Disease Control and
Prevention) has reported that more than three million people in the United States are
chronically infected with HCV.
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 (TMC435), a novel protease inhibitor in phase
III clinical development for hepatitis C that is being developed in collaboration with
Janssen R&D Ireland.
In June 2011, Medivir acquired the specialty pharmaceutical company BioPhausia and
today Medivir has a broad product portfolio with prescription pharmaceuticals in the
Medivir’s first product, the unique cold sore product Xerese(R)/Xerclear(R), is
launched in collaboration with GlaxoSmithKline to be sold OTC under the brand name ZoviDuo
in Europe, Japan and Russia.
For more information about Medivir, please visit the Company’s website:
For more information please contact: Medivir Rein Piir, EVP Corporate Affairs & IR Direct: +46-8-440-6550 or: Mobile: +46-708-537-292 M:Communications Europe: Mary-Jane Elliott, Amber Bielecka, Hollie Vile firstname.lastname@example.org +44(0)20-7920-2330
SOURCE Medivir AB