R Tech Ueno Completes Phase 2a Clinical Study of RK-023 to Treat Androgenetic Alopecia

Androgenetic alopecia, which is male-pattern alopecia, is a gradually progressive hair-thinning and alopecic disease with replacement of thick long hair by thin, short and soft hair

Jan 2011

R-Tech Ueno, Ltd. is pleased to announce that the Phase 2a clinical study of RK-023 to treat androgenetic alopecia (note 1) 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 (Note 2), randomized and placebo-controlled (Note 3) 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 (Note 4) 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 (Note 4) 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."

Note 1) Androgenetic alopecia, which is male-pattern alopecia, is a gradually progressive hair-thinning and alopecic disease with replacement of thick long hair by thin, short and soft hair without hair regeneration localized in the parietal to the frontal region under the effect of androgenic hormone after puberty, finally leading to atrophy in the hair follicles and reduction in the number of hair. About 12 million males are affected in Japan.

Note 2) Double-blind is a study method usually on human subjects in an attempt to eliminate subjective bias on the part of both experimental subjects and experimenters.

Note 3) Study drug without medical agent

Note 4) Phototrichogram is a noninvasive technique that analyzes hair density, hair diameter and a hair growth rate. A magnified photograph on a scalp hair cut area is analyzed.

Note 5) Anagen hair is defined as hair with a growth rate of 0.2 mm or more per day through phototrichogram. Anagen is the phase during which hair grows. Decrease of an anagen hair rate represents the progression of androgenetic alopecia.

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