Sucampo Reports Top-Line Results of Phase 2 Clinical Trial of Cobiprostone for Prevention of NSAID-Induced Gastrointestinal Injuries
BETHESDA, Md.--(BUSINESS WIRE)--Jul 1, 2009 - Sucampo Pharma Americas, Inc., a wholly owned subsidiary of Sucampo Pharmaceuticals, Inc. (NASDAQ:SCMP), today reported top-line results from its phase 2 clinical trial of orally administered cobiprostone for the prevention of gastric ulcers and other gastrointestinal injuries in patients treated with non-steroidal anti-inflammatory drugs (NSAIDs).
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 trial. All patients in the trial received 500 mg of naproxen twice a day. There were four treatment cohorts: one cohort received placebo while the other three cohorts received 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 during the 12-week treatment period; overall incidence of duodenal ulcers; 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 measured on a standardized grading scale.
A top-line analysis of data from the trial indicates that patients receiving cobiprostone experienced a lower overall incidence of ulcers: at Week 12, patients receiving the 54 mcg dose experienced a 50.0% reduction in the overall incidence of gastric ulcers when compared to patients taking placebo. Cobiprostone patients experienced an overall statistically significant reduction in the number of gastric erosions through the treatment period of twelve weeks compared to placebo patients. The reduction of gastric erosions through Week 12 was dose dependent, with 36 mcg and 54 mcg demonstrating statistical significance. The time-to-onset of all ulcer or erosion development was delayed in the cobiprostone cohorts with overall statistical significance across the 12 week treatment period.
The retention rates of patients taking naproxen with cobiprostone at Week 12 were statistically significant when compared to patients taking naproxen with placebo and increased in a dose-dependent manner. The rates were 40% for placebo vs. 47%, 52% and 77% for cobiprostone 18 mcg, 36 mcg and 54 mcg, respectively. The median number of days in the treatment period was 55.0 days for patients taking placebo compared to 60.0, 82.0, and 83.0 days for cobiprostone 18 mcg, 36 mcg and 54 mcg, respectively.
Overall, the data showed cobiprostone was well tolerated in patients receiving NSAID therapy. The related overall adverse event rates were 66.7% for placebo, compared to 60.0%, 71.0% and 67.7% for cobiprostone 18 mcg, 36 mcg and 54 mcg, respectively. The most common related adverse events were: diarrhea, at 13.3% for placebo compared to 13.3%, 32.3% and 35.5% for cobiprostone 18 mcg, 36 mcg and 54 mcg, respectively; nausea, at 10.0% for placebo vs. 10.0%, 16.1% and 16.1% for cobiprostone 18 mcg, 36 mcg and 54 mcg, respectively; and gastritis, at 13.3% for placebo vs. 13.3%, 6.5% and 9.7% for cobiprostone 18 mcg, 36 mcg and 54 mcg, respectively. The drug-related gastrointestinal adverse event rates were 66.7% for placebo vs. 60.0%, 67.7%, and 67.7% for cobiprostone 18 mcg, 36 mcg and 54 mcg, respectively, which suggest that gastrointestinal adverse events other than diarrhea and nausea may be related to the naproxen therapy. Withdrawal rates from the trial due to an adverse event were: 21.9% for placebo vs. 13.3%, 16.1% and, 16.1% for cobiprostone 18 mcg, 36 mcg and 54 mcg, respectively.
Ryuji Ueno, M.D., Ph.D., Ph.D., Chair and CEO of Sucampo Pharmaceuticals, Inc., said, “I am pleased with these results. We believe cobiprostone may have the potential to offer patients a new treatment strategy for the prevention of gastrointestinal injuries associated with NSAID therapy. We look forward to working with our investigators to determine the next steps in clinical development. We also intend to initiate contact with potential commercialization partners to understand the possible commercial alternatives if cobiprostone succeeds in further clinical development.”
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 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 at what Sucampo believes are clinically relevant doses.
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.
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 also is developing the drug for additional gastrointestinal disorders with large potential markets. In April 2009, Sucampo acquired U.S. and Canadian rights to Rescula®, an FDA-approved treatment for open-angle glaucoma and ocular hypertension. Sucampo plans to re-launch Rescula in 2010, and to develop it for additional ophthalmic indications. 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 and its products, visit www.sucampo.com.
Amitiza is a registered trademark of Sucampo Pharmaceuticals, Inc. and Rescula is a registered trademark used under license.
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, 2008 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.
Posted: July 2009