Boehringer Ingelheim Expands Investigation of Interferon-free Hepatitis C Treatment Regimens to Reach More Patient Types through Presidio Pharmaceuticals Clinical Collaboration
First Phase 2a study includes Presidio’s PPI-668
in genotype-1a infected patients; collaboration offers the potential to
explore additional HCV genotypes in future trials
Boehringer Ingelheim’s Phase 3 interferon-free HCVerso® trials in genotype-1b HCV infected patients are fully enrolled; results are expected in Q2 2014
Ridgefield, CT, September 10, 2013 –
Boehringer Ingelheim Pharmaceuticals, Inc. today announced the completion of patient enrollment for a Phase 2a clinical trial (NCT01859962
investigating a new interferon-free, all-oral, direct-acting antiviral
(DAA) combination treatment for patients with genotype-1a chronic
hepatitis C virus (HCV) infection. This trial is conducted in
collaboration with Presidio Pharmaceuticals, Inc. and evaluates
Boehringer Ingelheim’s investigational compounds, the protease inhibitor
faldaprevir (BI 201335) and non-nucleoside NS5B polymerase inhibitor,
deleobuvir (BI 207127), in combination with Presidio’s investigational
pan-genotypic NS5A inhibitor, PPI-668, with and without ribavirin.
trial includes 36 treatment-naïve genotype-1a infected patients treated
for 12 weeks with this all-oral DAA regimen, with 24 weeks of
post-treatment follow-up. The primary endpoint of the trial
is sustained virologic response 12 weeks after treatment is completed
(SVR12). This Phase 2a trial of a novel combination therapy is a part of
Boehringer Ingelheim’s commitment to develop new, tailored interferon
and ribavirin-free HCV regimens for a broad range of HCV patients.
March 2013, the two companies entered a non-exclusive collaboration to
evaluate the three DAAs in combination regimens. Both companies will
retain all rights to their respective compounds. Presidio has
operational responsibility for this collaborative trial, with oversight
by an intercompany project team. Final results are expected in Q2 2014.
“We are proud to
announce that we have completed enrollment in this collaborative trial
designed to investigate an all-oral combination of compounds to treat
patients with HCV. This further compliments our ongoing Phase 3 HCVerso®
trial program, which aims to provide interferon-free treatment to
genotype-1b patients,” said Peter Piliero, M.D., Vice President,
Clinical Development and Medical Affairs, Boehringer Ingelheim
Pharmaceuticals, Inc. “Through the development of our own pipeline
compounds and through new collaborations like this we aim to provide
interferon- and ribavirin-free regimens for a wide range of patients
and hepatitis C genotypes, including the most challenging types to
cure. In prior clinical trials, PPI-668 has shown pan-genotypic
properties that bear the potential to explore the efficacy of this
regimen in a wider range of HCV genotypes.”
interferon from treatment regimens is a critical goal in hepatitis C
management. Clinical studies have shown that up to 50 percent of
patients may not be eligible for treatment with interferon due to
contraindications. Patients may also find interferon challenging due to
long treatment duration and side-effects. These side-effects commonly
include fatigue, anxiety, depression, gastrointestinal and flu-like
symptoms. More serious side-effects may include heart failure, sepsis,
leukopenia and vision loss.
evaluating multiple DAAs are exciting because they can help bring us
closer to our goal of developing more effective and tolerable
interferon-free and potentially ribavirin-free therapies,” said Jacob
Lalezari, M.D., Director of Quest Clinical Research in San Francisco,
CA. “By treating patients with multiple compounds that attack the
hepatitis C virus in different ways, we hope to be able to cure more
patients in less time with fewer of the side-effects associated with
existing treatment options.”
deleobuvir are investigational compounds and not approved by the FDA.
Their safety and efficacy have not been established.
Boehringer Ingelheim has a comprehensive interferon-free clinical trial program, HCVerso®, which includes three pivotal Phase 3 studies. The HCVerso®
studies aim to enroll approximately 1,100 treatment-naïve and
experienced HCV genotype-1b (GT-1b) patients, including those who are
interferon eligible or ineligible, and those with compensated liver
For more information regarding the trial, please visit www.clinicaltrials.gov.
About Boehringer Ingelheim in Hepatitis C Virus (HCV)
In partnership with the scientific community, our clinical trial
program is rigorously designed to find answers to the challenges that
HCV patients face, including those who are the most difficult to treat.
Our pivotal HCV clinical trials for faldaprevir and deleobuvir are
comprised of two multi-trial programs, STARTVerso® and HCVerso®.
Faldaprevir, also known
as BI 201335, is an investigational, oral protease inhibitor that is
specifically designed to target viral replication in the liver.
Boehringer Ingelheim is developing faldaprevir as a core component of
both interferon-based and interferon-free hepatitis C treatment
regimens. STARTVerso®1 is the first of an ongoing multi-study
Phase 3 trial program that is evaluating faldaprevir combined with
PegIFN/RBV. Three additional trials in treatment-naïve,
treatment-experienced and HIV co-infected patients with chronic
genotype-1 HCV are near clinical completion. Deleobuvir, also known as
BI 207127, is an investigational NS5B non-nucleoside polymerase
inhibitor that has shown the potential to eliminate interferon from HCV
treatment when combined in a regimen with faldaprevir and RBV. Phase 2
trials of this interferon-free regimen have been completed and Phase 3
HCVerso® trials investigating this regimen are now underway.
As part of our long-term commitment to HCV, the company is exploring
other combinations of investigational HCV compounds that work in
complementary ways. The recent collaboration of Boehringer Ingelheim
with Presidio Pharmaceuticals, Inc. for a Phase 2a clinical study
investigating an interferon- and ribavirin-free, all-oral combination is
part of the company’s continued commitment to discover and develop
innovative options for the treatment of HCV.
STARTVerso® and HCVerso® are registered service marks of Boehringer Ingelheim International GmbH.
Hepatitis C is a
blood-born infectious disease and a leading cause of chronic liver
disease, transplant and failure that affects as many as 150 million
people globally. In the United States, an estimated 4.1 million
Americans have been infected with HCV, of which approximately 3.2
million have chronic HCV infection. Since 1999 there has been a
significant increase in deaths due to chronic HCV, which accounts for
10,000 -12,000 deaths in the United States per year.
About Boehringer Ingelheim
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 of
The Boehringer Ingelheim
group is one of the world’s 20 leading pharmaceutical companies.
Headquartered in Ingelheim, Germany, it operates globally with 140
affiliates and more than 46,000 employees. Since it was founded in 1885,
the family-owned company has been committed to researching, developing,
manufacturing and marketing novel medications of high therapeutic value
for human and veterinary medicine.
Social responsibility is
a central element of Boehringer Ingelheim’s culture. 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 www.us.boehringer-ingelheim.com
About Presidio in Hepatitis C Virus (HCV)
Presidio Pharmaceuticals, Inc. is a San Francisco-based clinical stage
specialty pharmaceutical company focused on the discovery and
development of oral pan-genotypic therapeutics for HCV patients.
Efforts are currently focused on novel inhibitors of both the HCV NS5A
and NS5B genes. PPI-668 is an investigational, pan-genotypic, once
daily, NS5A inhibitor. In earlier clinical studies in healthy volunteers
and HCV-infected patients, PPI-668 has been well-tolerated to date with
no serious or severe adverse events and no apparent pattern of
treatment-related clinical side effects or laboratory abnormalities.
PPI-668 achieves plasma concentrations high enough to inhibit most
pre-existing resistant variants and achieves steady-state levels after a
single dose. In a clinical study of PPI-668 monotherapy in GT1
HCV-infected patients, viral load reductions of 3.5 to 3.7 log10 HCV
were achieved in 1-2 days. Activity was also noted in GT3a HCV-infected
inhibitor, PPI-383, is a novel pan-genotypic non-nucleoside inhibitor
with potential to inhibit all of the major HCV genotypes. This compound
is currently in Phase 1 studies in healthy subjects. For more
information, please visit our website at: www.presidiopharma.com.
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