Santarus Announces Publication of Results from UCERIS Pivotal Study in Gastroenterology
UCERIS 9 mg statistically more effective than placebo for inducing
remission in patients with active, mild to moderate ulcerative colitis
SAN DIEGO--(BUSINESS WIRE)--
Inc. (NASDAQ: SNTS) today announced that results from its CORE I
clinical study, one of two of the company's pivotal Phase III clinical
studies with UCERIS™ (budesonide) in ulcerative colitis, have
been published online in the journal Gastroenterology. The
article titled, Once-Daily Budesonide MMX®
Extended-Release Tablets Induce Remission in Patients with Mild to
Moderate Ulcerative Colitis — Results from the CORE I Study can be
found online at www.gastrojournal.org.
The results from CORE I indicate that the investigational drug UCERIS 9
mg had a statistically significant benefit over placebo in the primary
endpoint of combined clinical and endoscopic remission at week 8 among
patients with active, mild to moderate ulcerative colitis. The U.S. Food
and Drug Administration (FDA) is currently reviewing the company's New
Drug Application (NDA) for UCERIS for the induction of remission in
patients with active, mild to moderate ulcerative colitis with a target
action date of January 16, 2013.
The percentage of patients achieving the primary endpoint of combined
clinical and endoscopic remission at week 8 in the UCERIS 9 mg group was
significantly greater than that seen in the placebo group (17.9% vs.
7.4%, p= 0.0143; odds ratio (OR): 2.71). The combined clinical and
endoscopic remission rate for UCERIS 6 mg (13.2% vs 7.4%, p= 0.1393; OR:
1.90) and for the reference drug Asacol® (mesalamine) 2.4 g
(12.1% vs 7.4%, p= 0.2200; OR: 1.71) were numerically greater than
placebo, but the differences were not statistically significant. These
results are summarized in the table below.
Combined Clinical and Endoscopic Remission, %
*Statistically significant (p < 0.025)
Efficacy analyses were done in the modified intent to treat population
under a prespecified statistical analysis plan, which included all
randomized patients who received at least one dose of a study drug and
excluded patients with major good clinical practice or entry criteria
violations and those with normal histology at baseline as determined by
central histopathology review.
"In this study, UCERIS 9 mg was well tolerated, and significantly more
effective than placebo in inducing remission in patients with active,
mild to moderate ulcerative colitis," said William J. Sandborn, M.D.,
Chief, Division of Gastroenterology, Director, University of California
San Diego (UCSD) IBD Center, Professor of Clinical Medicine, UCSD Health
System and lead author of the Gastroenterology article. "These
results suggest that UCERIS could provide an important addition to the
therapeutic landscape for clinicians who manage patients with mild to
moderate ulcerative colitis."
UCERIS 9 mg and 6 mg were generally well tolerated and the frequency of
treatment emergent adverse events was similar to placebo. The most
frequent treatment emergent adverse events (experienced by ≥ 5.0% of
patients in any treatment group) were worsening ulcerative colitis,
headache, pyrexia, insomnia, back pain, nausea, abdominal pain, diarrhea
and flatulence. Potential glucocorticoid effects occurred in similar
percentages of patients across all treatment groups. Potential
glucocorticoid effects were observed in 10.1% of patients in the placebo
group, 11.8% of patients in the UCERIS 9 mg group, 5.6% of patients in
the UCERIS 6 mg group and 7.9% of patients in the Asacol group.
Phase III Study (CORE* I and II) Design
*COlonic RElease budesonide for the treatment of mild to
moderate ulcerative colitis
UCERIS was evaluated for the treatment of active, mild to moderate
ulcerative colitis in two multicenter, randomized, double-blind,
double-dummy, placebo-controlled four-arm Phase III clinical studies.
The primary endpoint was the induction of combined clinical and
endoscopic remission, defined as an overall UCDAI score ≤ 1 after 8
weeks of treatment with subscores of 0 for both rectal bleeding and
stool frequency, a normal colonic mucosa without any sign of friability,
and ≥ 1 point reduction from baseline in the endoscopic score.
CORE I was conducted in North America and India and compared UCERIS 9
mg or 6 mg dosed once daily to placebo. The study included a reference
arm utilizing a dose of two Asacol (mesalamine) 400 mg delayed-release
tablets dosed three times a day resulting in a total of 2.4 grams
daily. The trial enrolled a total of 509 patients.
CORE II was conducted in Europe, Australia, Israel, and Russia
and compared UCERIS 9 mg or 6 mg dosed once daily to placebo. The
study included a reference arm that utilized a dose of three Entocort®
EC 3 mg capsules resulting in a once daily dose of 9 mg.
The trial enrolled a total of 511 patients.
The CORE I and CORE II clinical studies were powered to show a
statistical difference between the two UCERIS treatment arms and
placebo. The trials were not powered to show statistical differences
between UCERIS and the reference arms (Asacol in the CORE I study and
Entocort EC in CORE II).
About UCERIS (budesonide)
UCERIS is an investigational drug that contains budesonide, a
corticosteroid, in a novel oral tablet formulation that utilizes
proprietary MMX® multi-matrix system technology, which is
designed to result in the controlled release and distribution of
budesonide throughout the length of the colon. UCERIS is being developed
in collaboration with Cosmo Technologies Limited, a subsidiary of Cosmo
About Ulcerative Colitis
Ulcerative colitis is a form of inflammatory bowel disease (IBD) that
produces inflammation and ulcers along the inside of the colon. The
inflammation can interfere with the normal function of the colon, often
causing cramping, bloating, diarrhea, bleeding, fatigue, weight loss and
frequent bowel movements. It is believed that as many as 700,000 people
in the U.S. suffer from ulcerative colitis.
Santarus, Inc. is a specialty biopharmaceutical company focused on
acquiring, developing and commercializing proprietary products that
address the needs of patients treated by physician specialists. The
company's current commercial efforts are focused on GLUMETZA®
(metformin hydrochloride extended release tablets) and CYCLOSET®
(bromocriptine mesylate) tablets, which are indicated as adjuncts to
diet and exercise to improve glycemic control in adults with type 2
diabetes, and on FENOGLIDE®
(fenofibrate) tablets, which is indicated as an adjunct to diet to
reduce high cholesterol.
Santarus has a diverse product development pipeline. A New Drug
Application for UCERIS™ (budesonide) tablets for induction of
remission of active, mild to moderate ulcerative colitis is under review
by the U.S. Food and Drug Administration with a response expected in
January 2013. The pipeline also includes two late-stage investigational
drugs in Phase III clinical studies: RUCONEST® (recombinant
human C1 esterase inhibitor) for treatment of acute attacks of
hereditary angioedema and rifamycin SV MMX® for treatment of
travelers' diarrhea. In addition, the company's investigational
monoclonal antibody, SAN-300, is being evaluated in a Phase I clinical
program. More information about Santarus is available at www.santarus.com.
Santarus cautions you that statements included in this press release
that are not a description of historical facts are forward-looking
statements. The inclusion of forward-looking statements should
not be regarded as a representation by Santarus that any of its plans or
objectives will be achieved. Actual results may differ materially
from those set forth in this release due to the risks and uncertainties
inherent in Santarus' business, including, without limitation: whether
Santarus obtains regulatory approval for UCERIS in a timely manner or at
all, including whether the FDA agrees with the statistical analysis plan
for the UCERIS Phase III studies, the clinical interpretation of the
results and the conduct of the studies; whether the FDA requires
completion of additional clinical studies or other development programs
before approving UCERIS; whether the planned Phase IIIb clinical study
will be completed in a timely manner with a positive outcome; risks
associated with the collaboration with Cosmo relating to the MMX product
candidates, including the potential for termination of the
collaboration; competition from other products; unexpected adverse side
effects or inadequate therapeutic efficacy of Santarus' products and
product candidates; the scope and validity of patent protection for
Santarus' products and product candidates; and other difficulties or
delays relating to the development, testing, manufacturing and marketing
of, and obtaining and maintaining regulatory approvals for, Santarus'
products and product candidates; and other risks detailed in Santarus'
prior press releases as well as in prior public periodic filings with
the Securities and Exchange Commission.
You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof. All
forward-looking statements are qualified in their entirety by this
cautionary statement and Santarus undertakes no obligation to revise or
update this news release to reflect events or circumstances after the
date hereof. This caution is made under the safe harbor
provisions of Section 21E of the Private Securities Litigation Reform
Act of 1995.
and UCERIS™ are trademarks of Santarus, Inc.
GLUMETZA® is a trademark of Biovail
Laboratories International S.r.l. licensed exclusively in the United
States to Depomed, Inc. CYCLOSET® is a
trademark of VeroScience LLC. MMX® is a
trademark of Cosmo Technologies Limited.
RUCONEST® is a trademark of Pharming Group
Martha L. Hough
Finance & Investor Relations
Chief Financial Officer
Westwicke Partners, LLC
Stefan Loren, Ph.D.
Source: Santarus, Inc.
News Provided by Acquire Media
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