R-Tech Ueno, Ltd. is pleased to announce that the Phase 2a clinical study of RK-023 to treat androgenetic alopecia was completed by January 21, 2011.
Our company focuses on the area of no topical prescription drug in the market of androgenetic alopecia treatment and has developed a new topical drug. The Phase 2a clinical study of RK-023 for androgenetic alopecia treatment was performed in 48 patients with mild-to-moderate androgenetic alopecia, adult males aged 44 or less, to evaluate safety and pharmacokinetics, and efficacy. RK-023 was applied repeatedly for 13 weeks.
This clinical study was a double-masked, randomized and placebo-controlled study under Good Clinical Practice (GCP), and RK-023 was applied 2 mL each to a hair-thinning part of scalp twice daily in the patients with androgenetic alopecia. Laboratory tests, vital signs (blood pressure, pulse rate, body temperature and respiratory rate) and electrocardiogram were examined as the safety assessment. Concentrations of RK-023 and its main metabolite in plasma were determined as a pharmacokinetic study. Dermatologic examination for the degree of baldness, global photo assessment, subject self-assessment and phototrichogram were examined as the efficacy assessment.
Forty-eight patients (24 cases of the RK-023 group and 24 cases of the placebo group) were enrolled in this study. There was no severe adverse event. The frequency of mild adverse events was equal in both groups. In pharmacokinetic study, the main metabolite of RK-023 was slightly detected in plasma of only one patient. This showed that the transdermal absorption of RK-023 from the scalp was low. In the efficacy assessment, the RK-023 group showed possibility of improvement in global photo assessment and in numbers of anagen hair from the baseline compared with the placebo group.
The president of R-Tech Ueno, Yukihiko Mashima, MD, PhD, provided the following comments: "RK-023 has been developed as an anti-aging or a lifestyle drug that is one of the areas on research and development in R-Tech Ueno. I am very pleased to obtain the favorable results in safety assessment and in efficacy of global photo assessment. It is estimated that the global market size of drugs for androgenetic alopecia is approximately one billion US dollars. RK-023 is an important drug of our pipelines to develop our business. For the future we will facilitate this project to obtain approval more quickly with a view to the possibility of tie-up with domestic and foreign partners. RK-023 will improve the quality of life (QOL) for androgenetic alopecia patients."