Enrollment complete for phase III RP study

Bethesda, MD-Sucampo has announced that its development partner, R-Tech Ueno Ltd., has completed the enrollment of a phase III study for its treatment of retinitis pigmentosa (RP).

R-Tech is conducting the clinical trial of unoprostone isopropyl ophthalmic solution 0.15% at 38 medical institutions in Japan.

The randomized, double-blind, placebo-controlled study will evaluate whether the treatment improves central retinal sensitivity as determined by Humphrey Field Analyzer in patients with RP.

The study’s primary endpoint is the value of mean retinal sensitivity at four central points at 1 year. 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, MD, PhD, chairman, chief executive officer, and chief scientific officer of Sucampo.

With the completion of the phase III trial enrollment, Dr. Ueno said R-Tech expects to complete the study by the end of 2014, with 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,” he said. “We look forward to the possibility of helping to meet the unmet needs of patients suffering from RP in these countries.”

The study is being funded through an agreement between R-Tech and the Japan Science and Technology Agency. Sucampo licensed from R-Tech the exclusive development and commercialization rights to the treatment globally except for Japan, China, Taiwan, and Korea.

Both the FDA and the European Medicines Agency have granted orphan drug designation to the treatment.

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