ROCKVILLE, Md., April 19, 2016 (GLOBE NEWSWIRE) -- Sucampo Pharmaceuticals, Inc. (Sucampo) (NASDAQ:SCMP), a global biopharmaceutical company, today announced top-line data from a Phase 2a study of cobiprostone in patients with proton pump inhibitor (PPI)-refractory non-erosive reflux disease (NERD) or symptomatic gastroesophageal reflux disease (sGERD). While cobiprostone demonstrated significant benefit in some of the secondary measures of this exploratory study, the trial did not meet its primary endpoints and, based on these data, Sucampo intends to discontinue development of cobiprostone for PPI-refractory NERD/sGERD.
“At Sucampo, we remain focused on making scientifically-driven decisions to prioritize those pipeline candidates with the most potential to address critical unmet needs. As a result of these new efficacy findings, we have decided to discontinue development of cobiprostone in NERD/sGERD,” said Peter Kiener, D. Phil, Chief Scientific Officer of Sucampo. “While these data did not support the advancement of cobiprostone in this indication, the data did demonstrate that cobiprostone was well-tolerated, and this is consistent with our earlier Phase 1 studies. We plan to continue our development of cobiprostone in our ongoing Phase 2a study for the prevention of oral mucositis – a disorder with very different underlying pathophysiology and clinical endpoints. This development plan includes a futility analysis on the ongoing trial in the second half of this year.”
The randomized, double-blind, placebo-controlled, multicenter, Phase 2a study in NERD/sGERD investigated the safety and efficacy of cobiprostone or placebo administered three times daily over eight weeks in 153 NERD and sGERD patients. In the study, top-line data indicate that cobiprostone did not meaningfully improve heartburn symptoms as determined by patient reported outcomes, the primary endpoint of the study. Cobiprostone was generally well-tolerated, with the most common adverse event being mild diarrhea.
Cobiprostone is a locally-acting chloride channel activator that works to stimulate and protect the mucosal barrier function and is currently being developed for the prevention of oral mucositis in patients suffering with head and neck cancer receiving concurrent radiation and chemotherapy.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. is focused on the development and commercialization of medicines that meet major unmet medical needs of patients worldwide. Sucampo has two marketed products – AMITIZA, its lead product, and RESCULA – and a pipeline of product candidates in clinical development. A global company, Sucampo is headquartered in Rockville, Maryland, and has operations in Japan, Switzerland and the U.K. For more information, please visit www.sucampo.com.
The Sucampo logo and the tagline, The Science of Innovation, are registered trademarks of Sucampo AG. AMITIZA is a registered trademark of Sucampo AG.
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Sucampo Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, and other statements that are not historical facts. The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the impact of pharmaceutical industry regulation and health care legislation; Sucampo's ability to accurately predict future market conditions; dependence on the effectiveness of Sucampo's patents and other protections for innovative products; the effects of competitive products on Sucampo’s products; and the exposure to litigation and/or regulatory actions.
No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Sucampo undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Sucampo's business, particularly those mentioned in the risk factors and cautionary statements in Sucampo's most recent Form 10-K as filed with the Securities and Exchange Commission on March 11, 2016, as well as its filings with the Securities and Exchange Commission on Forms 8-K and 10-Q since the filing of the Form 10-K, all of which Sucampo incorporates by reference.
Contact: Sucampo Pharmaceuticals, Inc. Silvia Taylor Senior Vice President, Investor Relations and Corporate Affairs 1-240-223-3718 email@example.com
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