- Simeprevir achieved SVR12 rates (viral cure) of 79% to 81% in the
three pivotal phase III trials QUEST-1, QUEST-2 and PROMISE in genotype 1
hepatitis C patients.
- The overall results demonstrate that
simeprevir is safe and well tolerated with a safety profile of the
simeprevir treatment arms similar to the placebo control.
- A majority of the patients, 85-93%, were able to stop all treatment after 24 weeks.
Sweden — Medivir AB (OMX: MVIR) today announced top-line results from
three pivotal phase III trials examining the one pill, once-daily,
investigational protease inhibitor, simeprevir (TMC435), administered
with pegylated interferon and ribavirin.
Results from the QUEST-1
and QUEST-2 trials found that 80% and 81% of treatment-naive patients
with chronic genotype 1 hepatitis C infection who were treated with
simeprevir achieved sustained virologic response 12 weeks after the
planned end of treatment (SVR12). Results from the PROMISE trial found
that 79% of prior relapsed patients treated with simeprevir achieved
SVR12. All three studies utilized response-guided treatment (RGT)
criteria and 85%, 91% and 93 % of the patients, respectively, were
eligible to stop all treatments after 24 weeks.
safety, tolerability and efficacy results from these studies were
consistent with those previously obtained in phase II studies.
analysis of the phase III trials is ongoing and the full data set from
these studies will be submitted for presentation at future scientific
“We are extremely happy about the data from these
phase III studies, which robustly demonstrate high cure rates in both
treatment-experienced, so called relapsers, and treatment-naïve patient
groups, both including patients with severe liver disease. Together with
the very good safety profile and the fact that a large proportion of
the patients were eligible to end all treatments in a shorter time frame
as compared to current standard of care, should provide new hope for
large patient groups with this disease”, said Charlotte Edenius, EVP of
Research and Development, Medivir AB. “We look forward to seeking
regulatory approvals to bring simeprevir forward to help treat people
living with chronic hepatitis C.”
QUEST-1 (C208), QUEST-2 (C216) and PROMISE (C3007)
the global QUEST-1 and QUEST-2 trials, 394 and 391 respectively,
treatment-naïve patients with genotype 1 hepatitis C were randomized to
receive either 150 mg of once-daily simeprevir for 12 weeks plus
pegylated interferon and ribavirin for 24 or 48 weeks based upon
response guided treatment criteria (simeprevir group) or pegylated
interferon and ribavirin alone for 48 weeks (control group).
the PROMISE study, 393 patients, who had previous relapse after
completing HCV treatment with pegylated interferon and ribavirin, were
randomized to receive either 150 mg of once-daily simeprevir for 12
weeks plus pegylated interferon and ribavirin for 24 or 48 weeks based
on response guided treatment criteria (simeprevir group) or pegylated
interferon and ribavirin alone for 48 weeks (control group).
Summary – Safety and Tolerability
generally safe and well tolerated and overall incidence of adverse
events (AEs), including rash and anemia was similar to the placebo
control and consistent with prior simeprevir phase II studies.
all three phase III studies, AEs leading to permanent discontinuation
were lower in the simeprevir treated subjects compared to the placebo
control (pegylated interferon and ribavirin).
Mild and reversible
increases in bilirubin (total, direct and indirect) were observed in
simeprevir dose groups. There were no meaningful differences between
treatment groups for any of the other laboratory parameters. There were
no clinically significant findings on vital signs. Mean alanine
aminotransferase (ALT) levels decreased in all simeprevir treatment
For more information please contact:
Rein Piir, EVP Corporate Affairs & IR Direct: +46 8 440 6550 or: Mobile: +46 708 537 292.
Conference call Today, 20 December, at 14.00 (CET)
Phone numbers for participants from:
Sweden 0200 89 63 77
Europe +44 (0)20 3003 2666
USA +1 866 966 5335
The conference call will also be streamed live via a link on the website: www.medivir.com
About Simeprevir (TMC435)
a potent investigational NS3/4A protease inhibitor jointly developed by
Janssen and Medivir, is currently in phase III studies as a one pill
once-daily treatment taken in combination with pegylated interferon and
ribavirin for the treatment of genotypes 1 and 4 chronic hepatitis C
Global phase III studies of simeprevir include
QUEST-1 and QUEST-2 in treatment-naïve patients, PROMISE in patients who
have relapsed after prior interferon-based treatment, ATTAIN in prior
null-responder patients and studies in Japanese HCV genotype 1 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 in HCV genotype 4 patients.
Simeprevir is also being studied in phase II interferon-free trials both with and without ribavirin:
· Simeprevir in combination with Gilead Sciences’ sofosbuvir (GS7977)
in hepatitis C genotype 1 treatment-naïve or prior null responder
· Simeprevir in combination with BMS’s, daclatasvir in hepatitis C genotype 1 treatment-naïve or prior null responder patients
· Simeprevir in combination with Janssen’s TMC647055 and low
dose ritonavir in hepatitis C genotype 1 treatment-naïve, prior relapser
or null responder patients
· Simeprevir in combination with Vertex’s VX-135 in hepatitis C genotype 1 treatment-naïve patients to commence in 2013
For additional information about simeprevir, please visit www. clinicaltrials.gov (http://www.%20clinicaltrials.gov)
About Hepatitis C
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.
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
In June 2011, Medivir acquired the specialty
pharmaceutical company BioPhausia and today Medivir has a broad product
portfolio with prescription pharmaceuticals in the Nordics.
For more information about Medivir, please visit the Company’s website: www.medivir.com