DUBLIN, Oct. 5, 2018 /PRNewswire/ -- Allergan
plc (NYSE: AGN) today announced the initiation of two global
clinical research programs for brazikumab, an investigational drug
being studied for inflammatory bowel disease (IBD). INTREPID
(Crohn's disease) and EXPEDITION (ulcerative colitis), will
evaluate the safety and efficacy of brazikumab and will investigate
the role of biomarkers in determining a predictive response of
brazikumab in patients with IBD. They are the first active
comparator studies of an IL-23 inhibitor therapy in IBD to evaluate
biomarkers as potential predictors of treatment response and the
first randomized comparison of an IL-23 inhibitor versus
HUMIRA® (adalimumab) in Crohn's disease and
ENTYVIO® (vedolizumab) in ulcerative colitis.
Despite advancements in IBD treatments, up to 80 percent of
patients will never achieve full disease
remission.i In fact, many patients face rapid
disease progression early in their treatment course due to
ineffective or delayed therapies,ii which can
result in irreversible gastrointestinal (GI) damage and potential
surgery.iii
"Due to the complex nature and multifactorial causes of IBD, it
can be challenging to predict which patients need and will respond
to early advanced treatments," said Bruce
E. Sands, MD, MS, Dr. Burrill B. Crohn Professor of Medicine
at Mount Sinai Hospital in New
York. "If we are able to identify whether certain biomarkers
can predict a response to treatment, we may be able to select the
most appropriate therapy for patients earlier."
Allergan is initiating the INTREPID and EXPEDITION programs
following a Phase 2 clinical trial that showed higher
anti-inflammatory response and remission rates with brazikumab in
patients with Crohn's disease who had higher levels of a key IBD
biomarker compared to those who had lower levels.iv
"The personalized study design of the INTREPID and EXPEDITION
research programs reflect Allergan's commitment to finding new
approaches in how we address the needs of patients with our
medicines," said David Nicholson,
Chief R&D Officer, Allergan. "These programs are part of our
growing focus in gastroenterology, which will become even more
significant for Allergan in the coming years."
More about INTREPID and EXPEDITION
INTREPID is
a patient-centric Phase 2b/3,
multicenter, randomized, double-blind, double-dummy, placebo- and
active-controlled, parallel-group, Crohn's disease program. In
Stage 1 (Phase 2b), brazikumab will
be compared to placebo and HUMIRA® (adalimumab) and in
Stage 2 (Phase 3) brazikumab will be compared to HUMIRA®
only. Approximately 450 patients will be enrolled in Stage 1 and
690 patients in Stage 2. To the benefit of study participants, all
will have post-trial access to study treatments.
EXPEDITION is starting with a Phase 2, multicenter, randomized,
double-blind, double-dummy, placebo- and active-controlled,
parallel-group, study of patients with ulcerative colitis. The
safety and efficacy of brazikumab will be compared to placebo or
ENTYVIO® (vedolizumab). Approximately 375 patients will
be enrolled. Biomarker learnings from this study will be applied to
the planned Phase 3 part of the program.
The primary endpoints of INTREPID include evaluations of
endoscopic response and clinical remission based on loose stool
frequency and abdominal pain scores.The primary endpoints of
EXPEDITION include evaluations of endoscopic response and clinical
remission based on loose stool frequency and rectal bleeding. In
both programs, patients who previously received standard biologic
therapy (biologic-intolerant or -refractory) and those who were
never treated with biologic therapy (biologic-naïve) will be
enrolled. Patients who received conventional therapies, such as
corticosteroids or immunomodulators, will also be included. Where
available, participants will have access to study treatments after
the programs are completed until brazikumab is commercially
available or Allergan ceases development. INTREPID expects to begin
enrolling patients in December 2018.
EXPEDITION is actively enrolling patients. Learn more at
AllerganIBD.com.
More about IBD
Inflammatory bowel disease
(IBD), which includes Crohn's disease and ulcerative colitis,
causes chronic inflammation in the GI tract. Crohn's disease can
affect any part of the GI tract, from the mouth to the anus.
Ulcerative colitis, however, only affects the large intestine
(colon) and the rectum.
The exact causes of IBD are not fully understood.ii
It is a complex disease involving multiple genetic, immune system
and environmental factors that can lead to poor quality of life and
high economic and personal costs.ii
More about Allergan Gastroenterology
In addition to
INTREPID and EXPEDITION, Allergan is exploring investigational
products for diabetic gastroparesis (DG) and nonalcoholic
steatohepatitis (NASH) through its PLEDGE and AURORA research
programs. PLEDGE is studying relamorelin, an investigational drug
being evaluated for DG and AURORA is evaluating Cenicriviroc (CVC),
an investigational drug for liver fibrosis in adults with NASH.
Both relamorelin and CVC have been granted Fast Track status by the
U.S. Food and Drug Administration (FDA).
Learn more at AllerganGastroenterology.com.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered
in Dublin, Ireland, is a
bold, global pharmaceutical leader. Allergan is focused on
developing, manufacturing and commercializing branded
pharmaceutical, device, biologic, surgical and regenerative
medicine products for patients around the world.
Allergan markets a portfolio of leading brands and
best-in-class products for the central nervous system, eye care,
medical aesthetics and dermatology, gastroenterology, women's
health, urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, a
model of research and development, which defines our approach to
identifying and developing game-changing ideas and innovation for
better patient care. With this approach, Allergan has
built one of the broadest development pipelines in the
pharmaceutical industry.
Allergan's success is powered by our global colleagues'
commitment to being Bold for Life. Together, we build bridges,
power ideas, act fast and drive results for our customers and
patients around the world by always doing what is right.
With commercial operations in approximately 100
countries, Allergan is committed to working with
physicians, healthcare providers and patients to deliver innovative
and meaningful treatments that help people around the world live
longer, healthier lives every day.
For more information, visit Allergan's website
at www.Allergan.com.
Forward-Looking Statement
Statements contained in this press release that refer to future
events or other non-historical facts are forward-looking statements
that reflect Allergan's current perspective on existing trends and
information as of the date of this release. Actual results may
differ materially from Allergan's current expectations depending
upon a number of factors affecting Allergan's business. These
factors include, among others, the difficulty of predicting the
timing or outcome of FDA approvals or actions, if any; the impact
of competitive products and pricing; market acceptance of and
continued demand for Allergan's products; the impact of uncertainty
around timing of generic entry related to key products, including
RESTASIS®, on our financial results; risks associated with
divestitures, acquisitions, mergers and joint ventures; uncertainty
associated with financial projections, debt reduction, projected
cost reductions, projected synergies, restructurings, increased
costs, and adverse tax consequences; difficulties or delays in
manufacturing; and other risks and uncertainties detailed in
Allergan's periodic public filings with the Securities and Exchange
Commission, including but not limited to Allergan's Annual Report
on Form 10-K for the year ended December 31,
2017 and Allergan's Quarterly Report on Form 10-Q for the
period ended June 30, 2018. Except as
expressly required by law, Allergan disclaims any intent or
obligation to update these forward-looking statements.
i Feldman, P. A., Wolfson, D., & Barkin, J. S.
(2007). Medical Management of Crohn's Disease. Clinics in Colon and
Rectal Surgery, 20(4), 269–281.
http://doi.org/10.1055/s-2007-991026
ii Facts about Inflammatory Bowel Diseases. (2011,
May 1) CCFA.
http://www.crohnscolitisfoundation.org/resources/facts-about-inflammatory.html.
Retrieved on Sept. 18, 2018.
iii Lichtenstein, Gary R. et al. (2018). "ACG
Clinical Guideline: Management of Chron's Disease in Adults." The
American Journal of Gastroenterology, 113, 481–517
iv Sands, Bruce E. et al. (2017). Efficacy and Safety
of MEDI2070, an Antibody Against Interleukin 23, in
Patients with Moderate to Severe Crohn's Disease: A Phase 2a
Study. Gastroenterology, Volume 153, Issue 1, 77 - 86.e6
CONTACTS:
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SOURCE Allergan plc