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Sucampo Announces Completion Of Patient Enrollment In A Phase 3 Clinical Study Of Unoprostone Isopropyl For Retinitis Pigmentosa

Stocks in this article: SCMP

BETHESDA, Md., Oct. 21, 2013 (GLOBE NEWSWIRE) -- Sucampo AG, a subsidiary of Sucampo Pharmaceuticals, Inc. (Nasdaq:SCMP) ("Sucampo"), today announced that its development partner, R-Tech Ueno, Ltd. (R-Tech), completed the enrollment on-time for a Phase 3 study of unoprostone isopropyl ophthalmic solution 0.15% for the treatment of retinitis pigmentosa (RP). R-Tech is conducting the clinical trial at 38 medical institutions in Japan.

The randomized, double-blind, placebo-controlled study will evaluate whether unoprostone isopropyl ophthalmic solution improves central retinal sensitivity as determined by Humphrey Field Analyzer (HFA) in patients with RP. The study's primary endpoint is the value of mean retinal sensitivity at four central points at one year, and the target sample size is 180 patients.

"There are no drugs currently approved for the treatment of RP anywhere in the world, and we believe that unoprostone isopropyl may be a promising candidate for this indication," said Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman, Chief Executive Officer and Chief Scientific Officer of Sucampo. "With the completion of the Phase 3 trial enrollment, R-Tech expects to complete this study by the end of 2014 with top-line results available in early 2015. Upon successful results, Sucampo intends to work with regulatory authorities in the United States and the European Union to determine the incremental data that will be necessary to form application packages for each region, and we look forward to the possibility of helping to meet the unmet needs of patients suffering from RP in these countries."

This study is being funded through an agreement established in February 2013 between R-Tech and the Japan Science and Technology Agency (JST), the governmental agency responsible for the implementation of science and technology policy in Japan ( News Release - Feb. 4, 2013). Sucampo licensed from R-Tech the exclusive development and commercialization rights to unoprostone isopropyl globally except for Japan, Peoples Republic of China, Taiwan, and Korea. Both the U.S. Food and Drug Administration and the European Medicines Agency have granted orphan drug designation to unoprostone isopropyl for treatment of RP. Sucampo is not responsible for any development costs for the Phase 3 RP trial in Japan.

Retinitis pigmentosa is a genetic disease characterized by progressive, irreversible vision loss and decreasing visual acuity. As RP progresses, daily life becomes increasingly difficult. Blindness from all causes is among the most significant injuries to a patient's qualify of life and is a major driver of patient-based cost of care and lifestyle maintenance.

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