Sucampo Pharmaceuticals, Inc., (Nasdaq: SCMP), an emerging
pharmaceutical company developing prostone-based therapies for
age-related and other diseases, today announced that it has enrolled
the first patient in a multi-center Phase 2, dose-finding trial
evaluating one of its clinical compounds, cobiprostone (SPI-8811), for
the prevention of ulcers and other gastrointestinal injuries in
arthritis patients treated with nonsteroidal anti-inflammatory drugs
(NSAIDs).
"While NSAIDs are among the most commonly used medications in the
world, accounting for more than 70 million prescriptions in the U.S.
alone, unfortunately these drugs also are responsible for significant
gastrointestinal complications," said Byron Cryer, M.D., of University
of Texas Southwestern Medical Center. "We need to develop therapies
which can effectively prevent NSAID-induced gastrointestinal ulcers."
The double-blinded, randomized, placebo-controlled trial will
assess cobiprostone's safety and efficacy in preventing NSAID-induced
gastric and duodenal ulcers, erosions and dyspeptic symptoms in
patients with arthritis. The trial plans to enroll approximately 120
patients with osteoarthritis and/or rheumatoid arthritis at up to 15
sites in the United States.
The primary efficacy endpoint for the trial is the overall
incidence of gastric ulcers during study treatment. The study will
also evaluate secondary endpoints including overall incidence of
duodenal ulcers; the change in the number of ulcers and/or erosions
(gastric and duodenal) by patient; time-to-onset analysis of ulcer
and/or erosion development; and the severity of overall
gastrointestinal injury by using a standardized grading scale.
Cobiprostone is a functional fatty acid and a member of a class of
compounds called prostones. It is a locally acting chloride-channel
activator that works on ion channels located in the liver and the
gastrointestinal tract. Cobiprostone has been evaluated in two Phase 1
trials in healthy volunteers, and in three Phase 2 proof-of-concept
trials.
"Based on our pre-clinical experience with cobiprostone, which has
shown the ability to inhibit gastric ulcer formation induced by an
NSAID, and its favorable safety profile to date, we believe this
compound has the potential to become the standard of care to prevent
GI complications associated with NSAID use if it is approved," said
Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals' founder,
chairman and chief executive officer.
About NSAID-Induced Gastric Ulcers
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. While the
COX-2 (cyclooxygenase-2) inhibitors subclass of NSAIDs appears to
offer a reduced incidence of gastrointestinal injury, there are
concerns regarding the potential risk of increased cardiovascular
complications. Currently, misoprostol is the only the U.S. Food and
Drug Administration (FDA) approved drug for reducing the risk of
NSAID-induced gastric ulcers; however, the drug is frequently
associated with diarrhea and abdominal pain. Proton pump inhibitors
are extensively prescribed to treat existing gastric ulcers but have
not been approved specifically to prevent ulcer development.
Furthermore, there is cause for concern with calcium absorption
interference by these agents in elderly patients and linkages to
osteoporosis. H2-receptor antagonists have also been prescribed for
preventing NSAID-induced gastric injury, but with limited success.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc., an emerging pharmaceutical company
based in Bethesda, MD, focuses on the development and
commercialization of drugs based on prostones, a class of compounds
derived from functional fatty acids that occur naturally in the human
body. The therapeutic potential of prostones was first identified by
Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals' chairman and
chief executive officer. Dr. Ueno founded Sucampo Pharmaceuticals in
1996 with Sachiko Kuno, Ph.D., founding chief executive officer and
advisor, international business development. Sucampo Pharmaceuticals'
first product, AMITIZA(R) (lubiprostone), received marketing approval
from the FDA in January 2006 for the treatment of Chronic Idiopathic
Constipation in adults. To learn more about Sucampo Pharmaceuticals
and its products, visit www.sucampo.com.
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. Actual results may differ
materially from those indicated by such forward-looking statements as
a result of various important factors, including risks relating to:
the outcome of Sucampo Pharmaceuticals' Phase 2 trial of cobiprostone
for the prevention of NSAID-induced ulcers in arthritis patients;
Sucampo Pharmaceuticals' ability to secure additional funding to
conduct future clinical development of cobiprostone; Sucampo
Pharmaceuticals' dependence on its co-marketing alliance with Takeda
Pharmaceutical Company Ltd. and Takeda Pharmaceuticals North America;
and Sucampo Pharmaceuticals' ability to obtain, maintain and enforce
patent and other intellectual property protection for its discoveries.
These and other risks are described in greater detail in Sucampo
Pharmaceuticals' filings with the Securities and Exchange Commission
(SEC), including the quarterly report on Form 10-Q for the period
ended June 30, 2007, the final prospectus relating to Sucampo
Pharmaceuticals' initial public offering 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 release and should not be relied upon as representing its
views as of any subsequent date. Sucampo Pharmaceuticals anticipates
that subsequent events and developments will cause its views to
change. However, while Sucampo Pharmaceuticals may elect to update
these forward-looking statements publicly at some point in the future,
Sucampo Pharmaceuticals' specifically disclaims any obligation to do
so, whether as a result of new information, future events or
otherwise.