R-Tech Ueno announces protocol amendment of RK-023 Phase I trial for eyelash hypotrichosis

R-Tech Ueno (JASDAQ:4573) is pleased to announce protocol amendment of a Phase I Clinical Study of RK-023, a new compound being developed for the treatment of hypotrichosis of the eyelashes.

R-Tech Ueno has been developing this new compound (development code: RK-023), a novel physiologically active fatty acid derivative, for the treatment of dermatological diseases and has been conducting a Phase I clinical study of this compound in healthy adult male and female volunteers as part of a development effort for treatment of hypotrichosis of the eyelashes.

The study was planned to be conducted at medical institutions in Japan and the U.K. aiming at the global development of the drug, but the clinical research organization in the U.K. decided to close the medical institution where the study had been planned to be conducted, as a result of managerial judgment. Thus, the start of the study in U.K. was expected to be postponed due to procedures for change of medical institutions.

However, in a portion of the clinical study conducted simultaneously in Japan, administration of the investigational product and safety observation were successfully completed. In order to prevent delay of the development plan as a whole, we decided to discontinue the portion of the phase I study in the U.K., and to complete the phase I study as early as possible compiling the data of RK-023 we had already obtained in Japan.