Sucampo Completes Enrollment In Its Phase 2 Trial Of Cobiprostone For The Prevention Of NSAID-Induced Ulcers

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Clinical Trials / Drug Trials
Article Date: 12 Jan 2009 - 3:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Sucampo Pharmaceuticals, Inc. (NASDAQ:SCMP) an international biopharmaceutical company, announced that its wholly owned subsidiary, Sucampo Pharma Americas, Inc., has completed enrollment of its phase 2 clinical trial of cobiprostone designed to evaluate the compound's efficacy and safety for the prevention of ulcers and other gastrointestinal injuries in arthritis patients treated with non-steroidal anti-inflammatory drugs (NSAID).

"Gastrointestinal complications, ranging from mild dyspepsia to GI injury, present a significant risk to patients who rely on NSAIDs, which are among the most commonly used medications. A new medication that is a viable alternative for ulcer prevention and upper GI symptom management in patients taking NSAIDs would be welcomed by the medical community," said Byron Cryer, M.D., of the University of Texas Southwestern Medical Center, and one of the lead investigators in this study.

"I am pleased to see cobiprostone, Sucampo's second prostone compound that targets the gastrointestinal tract after lubiprostone, continue to advance in clinical development," said Dr. Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman and Chief Executive Officer of Sucampo. "If it is successful, cobiprostone would offer patients a preventive treatment regimen."

The phase 2 trial is a double-blinded, randomized, dose-ranging, placebo-controlled study designed to assess cobiprostone's efficacy and safety for preventing NSAID-induced ulcers in patients with arthritis. Three dose levels of cobiprostone are being tested: 18 mcg once a day; 18 mcg twice a day; and, 18 mcg three times a day for daily totals of 18, 36 and 54 mcg, respectively. A fourth cohort of patients will receive matching placebo. All patients in the trial will receive 500 mg of naproxen twice a day.

The primary efficacy endpoint for the trial is the overall incidence of gastric ulcers during the 12-week study treatment period. 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. The trial has enrolled a total of 124 patients with osteoarthritis and/or rheumatoid arthritis at 12 sites in the United States.

About cobiprostone

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 Sucampo believes has potent activities in the liver and the gastrointestinal tract. In 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 at what Sucampo management believes are clinically relevant doses.

Cobiprostone has been evaluated in two phase 1 clinical trials in healthy volunteers, and in three phase 2 clinical trials including one study in patients with Raynaud's disease, a study in patients with non-alcoholic fatty liver disease and in one study in patients with cystic fibrosis. Sucampo Pharmaceuticals, Inc. holds exclusive worldwide rights to develop and commercialize cobiprostone for all indications.

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 remain ongoing concerns regarding the potential risk of increased cardiovascular complications. Proton pump inhibitors are extensively prescribed to treat existing gastric ulcers but have not been approved specifically to prevent ulcer development. H2-receptor antagonists have also been prescribed for treating NSAID-induced gastric injury, but with limited success.

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. Dr. Ueno founded Sucampo Pharmaceuticals in 1996 with Sachiko Kuno, Ph.D., founding Chief Executive Officer and currently Advisor, International Business Development.

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 is also developing the drug for opioid-induced bowel dysfunction. In addition, Sucampo has a robust pipeline of compounds with the potential to target underserved diseases affecting millions of patients worldwide. Sucampo Pharmaceuticals, Inc. conducts its operations through three wholly owned subsidiaries: Sucampo Pharma Americas, Inc., based in Bethesda, Maryland; Sucampo Pharma Europe, Ltd., located in Oxford, U.K., and Basel, Switzerland; and, Sucampo Pharma, Ltd., located in Tokyo and Osaka, Japan. To learn more about Sucampo and its products, visit http://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. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors 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, 2007 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.

Sucampo Pharmaceuticals, Inc.