201335 for Hepatitis C Moves into Phase 3 Trials
Boehringer Ingelheim this week announced that enrollment has
begun for a Phase 3 clinical trial of its experimental HCV
NS3/4A protease inhibitor BI 201335.
antiviral agents that target various steps of the hepatitis C
virus (HCV) lifestyle are expected to bring about a new paradigm
in treatment for chronic hepatitis
C, especially for patients with hard-to-treat HCV genotype
At the European Association for the Study of the Liver's International
Liver Congress (EASL 2011) this month in Berlin, researchers presented
promising results from the
Phase 2b SILEN-C1 and SILEN-C2 trials, which evaluated BI201335
in people starting treatment for the first time and those who
did not respond to prior therapy, respectively.
Below is an edited excerpt from a Boehringer Ingelheim press release
announcing the start of follow-up Phase 3 trials for treatment-naive
and treatment-experienced genotype 1 chronic hepatitis C patients.
Ingelheim Announces Enrollment of First Patient
in Phase 3 Trial for Lead Hepatitis C Compound
program has been granted FDA Fast Track designation
CT -- April 26, 2011 -- Boehringer Ingelheim Pharmaceuticals,
Inc. today announced that enrollment has commenced at North American
sites in its pivotal Phase 3 clinical trial program for BI 201335,
the company's investigational, oral protease inhibitor for the
treatment of chronic hepatitis C virus (HCV). Phase 3 trials have
begun recruiting to evaluate BI 201335 plus standard-of-care (SOC)
in both treatment-naive and -experienced patients with chronic
genotype-1 HCV, the most challenging HCV genotype to treat. Results
from the Phase 3 studies are expected in the first half of 2013.
The U.S. Food and Drug Administration (FDA) has granted Fast Track
designation for the development program for BI 201335. Fast Track
is a process designed to facilitate the development and expedite
the review of drugs to treat serious diseases and fill an unmet
medical need. The purpose is to get important new drugs to patients
"We are pleased to have begun enrolling patients at North
American trial sites as we continue development of BI 201335,"
said Peter Piliero, MD, executive director, Medical Affairs, Boehringer
Ingelheim Pharmaceuticals, Inc. "We look forward to initiating
additional trials later this year in more patient populations,
including HCV-HIV coinfected patients, as we continue to advance
our HCV portfolio."
BI 201335 U.S. Phase 3 Trials
There are currently three Phase 3 trials enrolling patients around
the world that together seek to enroll approximately 1,875 patients.
Two of the three trials have U.S. trial sites that together plan
to enroll approximately 495 patients.
In the U.S., Study 1220.47 will enroll approximately 370 treatment-naive
genotype-1 HCV patients at 95 trial sites. This study will also
include additional sites in Canada, Taiwan and Korea. Study 1220.7
will enroll approximately 125 treatment-experienced genotype-1
HCV patients who have failed at least 12 weeks of prior treatment
with SOC at 40 trial sites in the U.S. This study also includes
additional trial sites around the world.
In treatment-naive patients (Study 1220.47), BI 201335 will be
dosed once-daily at either 120 mg or 240 mg for 12 or 24 weeks
in combination with 24 or 48 weeks of pegylated interferon and
ribavirin, the current HCV SOC. In treatment-experienced patients
(Study 1220.7) BI 201335 will be dosed once-daily at 240 mg for
12 or 24 weeks in combination with SOC for 48 weeks for prior
partial and null responder patients. Patients with prior relapse
will be dosed with BI201335 once-daily at 240 mg for 12 or 24
weeks in combination with SOC for 24 or 48 weeks total duration.
The primary endpoint of each trial is sustained viral response
(SVR), which is considered viral cure.
For more information about clinical trials involving BI 201335,
please visit www.clinicaltrials.gov.
About Boehringer Ingelheim in Virology
Boehringer Ingelheim has more than 6,900 scientists working in
cross disciplinary teams within our global R&D network in
six large therapeutic areas, including virology. In addition to
its ongoing research program for HCV, Boehringer Ingelheim has
a long-standing history in virology drug development, including
compounds for the treatment of HIV. The company has a well established
research center in Laval, Canada, dedicated to virology research
since the early 1990's, and is committed to developing new therapies
for virologic diseases with a high unmet medical need.
Boehringer Ingelheim in Hepatitis C Virus
BI 201335 is an investigational oral HCV NS3/4A protease inhibitor,
discovered from Boehringer Ingelheim's own research and development,
which has completed clinical trials through Phase 2b (SILEN-C
studies). This Phase 2 program supports the investigation of BI
201335 in Phase 3 trials. Boehringer Ingelheim is also developing
BI 207127, an NS5B RNA-dependent polymerase inhibitor that has
completed Phase 1 clinical trials. Phase 2 trials evaluating BI
207127 with BI 201335 in interferon-sparing regimens, both with
and without ribavirin, are currently underway.
About Boehringer Ingelheim Pharmaceuticals,
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield,
CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation
(Ridgefield, CT) and a member of the Boehringer Ingelheim group
The Boehringer Ingelheim group is one of the world's 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany,
it operates globally with 145 affiliates and more than 42,000
employees. Since it was founded in 1885, the family-owned company
has been committed to researching, developing, manufacturing and
marketing novel products of high therapeutic value for human and
As a central element of its culture, Boehringer Ingelheim pledges
to act socially responsible. Involvement in social projects, caring
for employees and their families, and providing equal opportunities
for all employees form the foundation of the global operations.
Mutual cooperation and respect, as well as environmental protection
and sustainability are intrinsic factors in all of Boehringer
For more information, please visit http://us.boehringer-ingelheim.com
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Ingelheim. Boehringer Ingelheim Announces Enrollment of First
Patient in Phase 3 Trial for Lead Hepatitis C Compound. Press
release. April 26, 2011.