Sucampo Pharmaceuticals initiates phase 3 trial of Lubiprostone for chronic idiopathic constipation in Japan

Sucampo Pharmaceuticals, Inc. today announced that its subsidiary, Sucampo Pharma, Ltd., has initiated enrollment and completed the randomization of the first patient into the pivotal phase 3 efficacy trial of lubiprostone for chronic idiopathic constipation (CIC) in Japan.

Under the terms of a license, commercialization and supply agreement Sucampo signed in February 2009 with Abbott Japan Co., Ltd., Sucampo will receive a milestone payment in the amount of $7.5 million in recognition of this achievement. Abbott has exclusive rights to market lubiprostone in Japan for the treatment of CIC.

Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman and Chief Executive Officer of Sucampo Pharmaceuticals, Inc., said, "We remain committed to our goal of broad international expansion of lubiprostone and this efficacy trial will increase our experience with the drug in the Japanese population."

This pivotal phase 3 double-blinded, placebo-controlled clinical trial is designed to evaluate the efficacy and safety of lubiprostone in Japanese patients with CIC over a 28-day treatment period. Patients will receive one lubiprostone 24-mcg, or placebo, capsule twice a day. This trial seeks to enroll approximately 116 patients, each of whom have a history of fewer than three spontaneous bowel movements (SBMs) per week for at least six months, as confirmed during a 14-day screening period. The primary efficacy endpoint is the change in SBMs at the end of the first week of treatment.

Sucampo also has initiated enrollment and initial dosing of Japanese CIC patients, for up to 48 weeks of treatment, in an open-label phase 3 safety trial of lubiprostone (trade name Amitiza®). This is an open-label, multi-center, confirmatory trial in which patients will receive one 24-mcg lubiprostone capsule twice a day. This trial seeks to enroll 200 patients, each of whom has a history of fewer than three SBMs per week for at least six months, as confirmed during a 14-day screening period. Efficacy parameters being measured in this long-term safety trial include the frequency of SBMs at every week and the changes in SBMs at every week.

In September 2008, Sucampo announced that lubiprostone met the primary endpoint of a statistically significant increase in mean change from baseline in SBM frequency after one week on treatment (p-value less than 0.0001) in a phase 2b trial in Japanese patients taking 24-mcg of lubiprostone twice daily versus placebo.