Sucampo Completes Patient Enrollment in Phase 3 Clinical Study of Unoprostone Isopropyl for Retinitis Pigmentosa
Sucampo AG, a subsidiary of Sucampo Pharmaceuticals (NASDAQ: SCMP), 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