ROCKVILLE, MD, USA I April 19, 2016 I 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.
SOURCE: Sucampo Pharmaceuticals
Post Views: 52
ROCKVILLE, MD, USA I April 19, 2016 I 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.
SOURCE: Sucampo Pharmaceuticals
Post Views: 52
