R-Tech Ueno (JASDAQ:4573) is pleased to announce the initiation of a Phase I clinical study of RK-023, a new compound that is being developed for the treatment of hypotrichosis of the eyelashes(1). The details of the trial are summarized below.
R-Tech Ueno has been developing this new compound (development code: RK-023) as a novel physiologically active fatty acid derivative for the treatment of dermatological diseases, and initiated a Phase I clinical study of this new compound in healthy adult male and female volunteers.
This is a placebo(2) -controlled, double-blind study(3) conducted under the principles of Good Clinical Practice (GCP) to evaluate the safety, tolerability, and pharmacokinetics of RK-023 in participants who will apply the study drug to the eyelid margin (at the base of the eyelashes) for 5 consecutive days. This study is conducted at medical institutions both in Japan and the UK, aiming at the global development of the drug.
Taking the possibility that the drug solution may unexpectedly enter the eyes when the study drug is applied, into consideration, we will also conduct another Phase I clinical study in Japan to evaluate the safety and pharmacokinetics of a single instillation of RK-023 into the eyes of healthy adult male volunteers.
“R-Tech Ueno has been developing RK-023 as an anti-aging or lifestyle drug in the research and development fields on which we focus our efforts. Fortunately, we could initiate the Phase I clinical study of RK-023 for the treatment of hypotrichosis of the eyelashes as scheduled, soon after the previous announcement of the completion of the Phase 2a clinical study of RK-023 for the treatment of androgenetic alopecia. The market for eyelash-related products including cosmetics such as eyelash liners is estimated at approximately 37 billion yen in Japan. In the US, only one ethical drug for the treatment of hypotrichosis of the eyelashes has been approved for marketing by the FDA(4) , and the distributor of that drug has announced an annual sales target of 500 million dollars,” the president of R-Tech Ueno, Yukihiko Mashima, MD, PhD said. “We will contribute to improve the quality of life (QOL) of patients with hypotrichosis of the eyelashes, and seek early approval of the drug by moving ahead with its global clinical development that starts with the Phase I clinical study that is conducted both in Japan and the UK.”
(1) A disease in which the eyelashes do not function properly, i.e., weak, short, sparse, or light-colored eyelashes cannot adequately protect the eyes from foreign bodies such as dust and abnormal light rays.
(2) A drug formulation that does not contain the active ingredient (RK-023)
(3) An experimental procedure to objectively conduct a clinical study, in which neither the subjects participating in the trial nor the doctors performing the trial know whether the study drug contains the active ingredient or whether a placebo is being used.
(4) Food and Drug Administration: The federal agency responsible for the administration of foods and drugs in the U.S. Based on scientific knowledge it technically implements the approval and regulation of foods, drugs, cosmetics, medical devices, and veterinary drugs; monitors the manufacture and distribution of products; regulates toxicity evaluations and clinical studies; and performs other related duties.
About development code: RK-023
RK-023 is the new compound developed by R-Tech Ueno as a novel physiologically active fatty acid derivative for the treatment of androgenetic alopecia and hypotrichosis of the eyelashes. The completion of the Phase 2a clinical study of RK-023 for the treatment of androgenetic alopecia has been announced in January 24th, 2011.
R-Tech Ueno, Ltd.