Published: May 03, 2010
Phase 2 Cobiprostone Data Presented at DDW
BETHESDA, Md. - (BUSINESS WIRE) - Sucampo Pharmaceuticals, Inc. (NASDAQ:SCMP) today presented results of a
phase 2 clinical trial of cobiprostone, an investigational drug, for the
prevention of gastric ulcers and other gastrointestinal injuries in
patients treated with non-steroidal anti-inflammatory drugs (NSAIDs).
These data were presented at the Digestive Disease Week (DDW) 2010
conference in New Orleans, Louisiana, as part of the distinguished
abstract plenary session.
Byron Cryer, M.D., the principal investigator in the trial and the John
C. Vanatta III Professor of Medicine at the University of Texas
Southwestern and North Texas VA Health Care System in Dallas, Texas,
said, "These data demonstrate that cobiprostone may be a new strategy
for prevention of gastrointestinal injury in patients receiving NSAIDs.
If successfully developed for this indication, cobiprostone would
protect a large number of patients."
Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman and Chief Executive Officer of
Sucampo Pharmaceuticals, Inc., said, "We believe that cobiprostone has
the potential to offer patients a means of preventing gastric injury
associated with NSAID therapy. We look forward to continuing its
clinical development and considering its potential in combination with
other therapies."
Results of the Trial
Highlights from the trial data were:
-
Use of high-dose cobiprostone was associated with a 50% reduction in
gastroduodenal ulcers when compared to placebo.
-
Time to onset of all ulcer and erosion development was statistically
significantly delayed in the cobiprostone groups across the 12-week
treatment period.
-
The mean treatment duration with naproxen was increased dose
dependently with cobiprostone treatment at 18, 36, and 54 mcg vs.
placebo (60.3, 62.1 and 71.1 days vs. 49.1 days, respectively).
-
Use of high-dose cobiprostone was associated with the lowest
percentage of patient discontinuations due to ulcer development.
-
Cobiprostone was well tolerated and may have the potential to prevent
clinically apparent gastrointestinal events with NSAID therapy.
About the Design of the Trial
A total of 124 patients with osteoarthritis and/or rheumatoid arthritis
at 12 sites in the U.S. were enrolled in this 12-week, double-blinded,
randomized, dose-ranging and placebo-controlled phase 2 clinical trial.
In addition to receiving 500 mg of naproxen twice a day patients in the
study were randomized into one of four treatment cohorts and received
either placebo or 18 mcg of cobiprostone either once, twice or three
times a day (daily totals of 18, 36 or 54 mcg, respectively).
Efficacy endpoints that were evaluated included: the overall incidence
of gastric ulcers at Week 12; incidence of gastric erosions;
time-to-onset of ulcer and/or erosion development; and the number of
days in treatment period. Patients were evaluated with gastro-duodenal
endoscopies at Weeks 4, 8 and 12. Patients who were diagnosed with an
ulcer during the trial were treated for one month with a proton-pump
inhibitor with a follow-up endoscopy to confirm healing.
About cobiprostone
Cobiprostone is a functional fatty acid and a member of a class of
compounds called prostones, which are formed in the body through
enzymatic activity, mediated by 15-PDGH. It is a locally acting chloride
channel activator with potent activity in the gastrointestinal tract. In
pre-clinical cellular assays, cobiprostone dose dependently activated
type-2 chloride channels in a protein kinase A-independent fashion. In
animal studies, cobiprostone protected against formation of ulcers
induced by indomethacin, an NSAID, and ulcers induced by stress and
demonstrated an acceptable safety profile.
Sucampo Pharmaceuticals, Inc. holds exclusive worldwide rights to
develop and commercialize cobiprostone for all indications.
About NSAID-Induced Gastric Ulcers
Non-steroidal anti-inflammatory drugs (NSAIDs) are among the most
commonly used drugs worldwide. Although the analgesic, anti-pyretic and
anti-inflammatory properties of NSAIDs are very effective for the
treatment of pain and inflammation, long-term use can cause
gastrointestinal injury ranging from upset stomach to ulcer formation
and gastrointestinal bleeding.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc., an international biopharmaceutical
company based in Bethesda, Maryland, focuses on the development and
commercialization of medicines based on prostones. The therapeutic
potential of prostones, which are bio-lipids that occur naturally in the
human body, was first identified by Ryuji Ueno, M.D., Ph.D., Ph.D.,
Sucampo Pharmaceuticals' Chairman and Chief Executive Officer. In
addition, Sucampo has a robust pipeline of compounds with the potential
to target under-served diseases affecting millions of patients worldwide.
Sucampo markets Amitiza (lubiprostone) 24 mcg in the U.S. for chronic
idiopathic constipation in adults and Amitiza 8 mcg in the U.S. to treat
irritable bowel syndrome with constipation in adult women. Sucampo also
is developing the drug for additional gastrointestinal disorders with
large potential markets. In addition, Sucampo has a robust pipeline of
compounds with the potential to target underserved diseases affecting
millions of patients worldwide.
Sucampo Pharmaceuticals, Inc. has three wholly owned subsidiaries:
Sucampo Pharma Europe, Ltd., located in the UK; Sucampo Pharma, Ltd.,
located in Japan; and Sucampo Pharma Americas, Inc., located in
Maryland. To learn more about Sucampo Pharmaceuticals Inc. and its
products, visit www.sucampo.com.
Amitiza is a registered trademark of Sucampo Pharmaceuticals, Inc.
Forward-Looking Statements
Any statements in this press release about future expectations, plans
and prospects for Sucampo Pharmaceuticals are forward-looking statements
made under the provisions of The Private Securities Litigation Reform
Act of 1995. Forward-looking statements may be identified by the words
"project," "believe," "anticipate," "plan," "expect," "estimate,"
"intend," "should," "would," "could," "will," " may" or other similar
expressions. Forward-looking statements include statements about the
potential utility of Amitiza and Rescula to treat particular
indications. Actual results may differ materially from those indicated
by such forward-looking statements as a result of various important
factors, including those described in Sucampo Pharmaceuticals' filings
with the Securities and Exchange Commission (SEC), including the annual
report on Form 10-K for the year ended December 31, 2009 and other
periodic reports filed with the SEC. Any forward-looking statements in
this press release represent Sucampo Pharmaceuticals' views only as of
the date of this press release and should not be relied upon as
representing its views as of any subsequent date. Sucampo does not
undertake any obligation to update any forward-looking statements
contained in this press release as a result of new information, future
events or otherwise, except as required by law.
Sucampo Pharmaceuticals, Inc.
Kate de Santis, 240-223-3834
kdesantis@sucampo.com
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