- Data from OPTIMIST-1 and OPTIMIST-2 Trials Showing SVR12 Rates of
97 Percent and 84 Percent to be Presented at The International Liver
Congress™ 2015 of the European Association for the Study of the Liver -
- SVR12 Rates of up to 100 Percent Achieved Among Subgroups in Both
Trials -
CORK, Ireland--(BUSINESS WIRE)--
Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies
of Johnson & Johnson (Janssen), today announced results for its
hepatitis C treatment simeprevir at The International Liver Congress™
2015 of the European Association for the Study of the Liver (EASL) in
Vienna. Late-breaking results from the Phase 3 OPTIMIST-1 and OPTIMIST-2
trials highlight the clinical outcomes of simeprevir in an all-oral
combination regimen in a wide range of patients with hepatitis C virus
(HCV) infection.
"The new data for simeprevir presented at The International Liver
Congress™ confirms its efficacy when combined with sofosbuvir in an
all-oral, ribavirin-free regimen for HCV patients, including those who
are treatment-naïve and treatment-experienced, both with and without
cirrhosis," said Gaston Picchio, hepatitis disease area leader, Janssen.
"These data further demonstrate the role of simeprevir within the HCV
treatment landscape, as it provides patients with an important
therapeutic option."
The results from the OPTIMIST-1 and OPTIMIST-2 trials are the first
Phase 3 data to be presented on simeprevir in combination with
sofosbuvir (SMV/SOF) in patients with genotype 1 chronic HCV infection,
both with and without cirrhosis. Sofosbuvir is a nucleotide analog NS5B
polymerase inhibitor developed by Gilead Sciences, Inc.
OPTIMIST-11
-
OPTIMIST-1 is a Phase 3, randomised, open-label trial to investigate
the efficacy and safety of the all-oral regimen of SMV/SOF among
treatment-naïve and treatment-experienced genotype 1 chronic
HCV-infected patients without cirrhosis. The primary objective was to
show superior sustained virologic response (SVR) at 12 weeks after
treatment (SVR12) with 12 and eight weeks of treatment with SMV/SOF
versus a historical control (patients previously treated with approved
regimens containing a direct-acting antiviral, pegylated interferon
and ribavirin).
-
Ninety-seven (97) percent of patients treated with SMV/SOF for 12
weeks (n=150/155) achieved SVR12, which was superior to the SVR12 rate
of 87 percent among the historical control.
-
SVR12 rates of 100 percent were seen among patients with IL28B
CC genotype (n=43/43) and those with baseline NS5A and NS3 Q80K
polymorphisms (n=9/9).
-
Patients treated with eight weeks of SMV/SOF achieved an SVR12 rate of
83 percent (n=128/155), which was not superior to the SVR12 rate of 83
percent in the historical control.
-
High SVR12 rates were seen among patients with baseline HCV RNA < 4
million IU/mL (96 percent; n=46/48), IL28B CC genotype (93
percent; n=38/41), patients with genotype 1b HCV infection (92
percent; n=36/39) and patients without baseline NS5A and Q80K
polymorphisms (89 percent; n=78/88).
-
The most frequently reported adverse events in the 12-week and
eight-week treatment arms were headache (14 and 17 percent,
respectively), fatigue (12 and 15 percent, respectively) and nausea
(15 and 9 percent, respectively).
OPTIMIST-22
-
OPTIMIST-2 is a Phase 3, open-label, single-arm trial to investigate
the efficacy and safety of SMV/SOF in treatment-naïve and
treatment-experienced genotype 1 chronic HCV-infected patients with
cirrhosis. The primary objective was to show superior SVR12 with 12
weeks of treatment with SMV/SOF versus a historical control.
-
Twelve (12) weeks of treatment with SMV/SOF resulted in SVR12 rates of
84 percent (n=86/103), which was superior to the SVR12 rate of 70
percent in the historical control.
-
Higher SVR12 rates were seen in patients with baseline NS5A
polymorphisms with or without NS3 Q80K polymorphisms (100 percent;
n=13/13), patients with albumin ≥4 g/dL (94 percent; n=47/50) and
treatment-naïve patients (88 percent; n=44/50).
-
The most common adverse events were fatigue (20 percent), headache (20
percent) and nausea (11 percent).
"Chronic HCV infection is a leading cause of cirrhosis, and once it is
developed, these patients can be very difficult to cure. The results of
the OPTIMIST-2 study demonstrate the safety and efficacy of the all-oral
regimen of simeprevir and sofosbuvir for genotype 1 chronic HCV patients
with cirrhosis," said Eric Lawitz, M.D., Texas Liver Institute,
principal investigator of the OPTIMIST-2 study.
About Hepatitis C
Hepatitis C, a blood-borne infectious disease of the liver and a leading
cause of chronic liver disease, is a major global public health concern.
Approximately 170 million people are infected with hepatitis C worldwide3
and 350,000 people per year die from the disease globally4
with 86,000 deaths in the European region each year.5 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.3
About Janssen's HCV Development Programme
The goal of the Janssen hepatitis C virus (HCV) clinical development
programme is to provide physicians with multiple treatment options in
order to offer patients the best possible chance at successful therapy.
Ongoing studies focus on the investigation of the NS3/4A protease
inhibitor simeprevir in a number of different treatment combinations and
HCV patient populations, including those who are difficult to cure.
Janssen's HCV pipeline also includes JNJ-56914845, an investigational
NS5A replication complex inhibitor currently in Phase 2 studies, and
following the acquisition of Alios BioPharma by Johnson & Johnson in
November 2014, AL-335, a uridine-based nucleotide analog in Phase 1
development, and AL-516, a guanosine-based nucleotide analog NS5B
polymerase inhibitor in pre-clinical development.
These compounds are being developed with the intent of targeting
critical steps of the HCV replication cycle.
About Simeprevir (OLYSIO®)
Simeprevir is an NS3/4A protease inhibitor which has been developed by
Janssen Sciences Ireland UC in collaboration with Medivir AB.
In November 2013, simeprevir was initially approved by the U.S. Food and
Drug Administration, and in May 2014, it was granted marketing
authorisation by the European Commission. Subsequent marketing
authorisations have followed in several other countries around the
world. Indications vary by market.
Janssen is responsible for the global clinical development of simeprevir
and has exclusive, worldwide marketing rights, except in the Nordic
countries. Medivir AB retains marketing rights for simeprevir in these
countries under the marketing authorisation held by Janssen-Cilag
International NV.
About Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we are dedicated to addressing and solving some of the most
important unmet medical needs of our time in oncology, immunology,
neuroscience, infectious diseases and vaccines, and cardiovascular and
metabolic diseases. Driven by our commitment to patients, we develop
innovative products, services and healthcare solutions to help people
throughout the world. Janssen R&D Ireland is part of the Janssen
Pharmaceutical Companies of Johnson & Johnson. Please visit http://www.janssenrnd.com
for more information.
# # #
This press release contains "forward-looking statements" as defined in
the Private Securities Litigation Reform Act of 1995 regarding product
development. The reader is cautioned not to rely on these
forward-looking statements. These statements are based on current
expectations of future events. If underlying assumptions prove
inaccurate or known or unknown risks or uncertainties materialize,
actual results could vary materially from the expectations and
projections of Janssen R&D Ireland and/or Johnson & Johnson. Risks and
uncertainties include, but are not limited to: challenges and
uncertainties inherent in new product development, including the
uncertainty of clinical success and of obtaining regulatory approvals;
competition, including technological advances, new products and patents
attained by competitors; challenges to patents; changes to applicable
laws and regulations, including global health care reforms; and trends
toward health care cost containment. A further list and description of
these risks, uncertainties and other factors can be found in Johnson &
Johnson's Annual Report on Form 10-K for the fiscal year ended December
28, 2014, including in Exhibit 99 thereto, and the company's subsequent
filings with the Securities and Exchange Commission. Copies of these
filings are available online at www.sec.gov,
www.jnj.com
or on request from Johnson & Johnson. None of the Janssen Pharmaceutical
Companies or Johnson & Johnson undertakes to update any forward-looking
statement as a result of new information or future events or
developments.
Date of preparation: April 2015
Job code: PHGB/HET/0415/0001b
References
_____________________
1 A Phase 3, randomised, open-label study to evaluate the
efficacy and safety of 12 and 8 weeks of treatment with simeprevir plus
sofosbuvir in treatment-naïve and -experienced patients with chronic HCV
genotype 1 infection without cirrhosis: The OPTIMIST-1 study. Presented
at The International Liver Congress™ 2015.
2 A Phase 3, open-label, single-arm study to evaluate the
efficacy and safety of 12 weeks of simeprevir plus sofosbuvir in
treatment-naïve or -experienced patients with chronic hepatitis c virus
genotype 1 infection and cirrhosis: The OPTIMIST-2 study. Presented at
The International Liver Congress™ 2015.
3World Health Organisation, Hepatitis C. Available at: http://www.who.int/csr/disease/hepatitis/Hepc.pdf
Last accessed April 2015.
4World Health Organisation. Hepatitis C. Fact sheet N. 164.
Available at: http://www.who.int/mediacentre/factsheets/fs164/en/.
Last accessed April 2015.
5 Muhlberger M et al. HCV-related burden of disease in
Europe: a systematic assessment of incidence, prevalence, morbidity, and
mortality. BMC Public Health 2009;9:34.
Janssen
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425 00
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Source: Janssen
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