TOKYO, July 21 R-Tech Ueno, Ltd. announced on July 17 that as a phase 1 clinical study on the new compound RK-023 that is being developed by our company as a therapeutic drug of androgenetic alopecia (male pattern baldness; see the note below) has been completed.
The phase 1 clinical study of RK-023 consisted of a patch test (open, closed, photo-patch test), single-dose study and 5-day repeated-dose study. Since no serious adverse event occurred in each test, RK-023 seems to hardly cause any safety problem in the human body.
As the first step, patch tests were conducted to obtain data on skin irritation. Using RK-023 preparation and a placebo, the tests were conducted on 20 healthy adult males by the following 3 methods and the results were evaluated.
No adverse event occurred and the resulting irritation was negligible in each test.
As the next step, single and 5-day repeated applications of RK-023 preparation to the scalp were conducted by a randomized, placebo-controlled, double blind method to evaluate the safety and pharmacokinetics of the drug. In the single-dose study, 2 ml of RK-023 preparation was applied to the vertex region of 6 out of 9 healthy adult males and a placebo to that of the remaining 3 subjects. The applied drug was spread widely covering the vertex region in order to investigate the safety in the entire body and scalp. No serious adverse event occurred. After application of the drug, blood and urine were collected in the lapse of time to determine drug concentrations. However, the drug concentration was below the quantification limit at any of the prescribed time points. In the 5-day repeated-dose study, in the morning and at night 2 ml of RK-023 preparation or 2 ml of placebo was applied to 6 and 2 out of 8 healthy adult males respectively. No serious adverse event was observed during the total 9 times of application up to the morning of day 5. When the drug concentration in the blood was measured, the level was below the quantification limit as in the case of the single-dose study.
As described above, percutaneous absorption of the drug was not high even after continuous application in the morning and at night for 5 days, suggesting hardly any safety problem.
Yukihiko Mashima, Representative Director and President of R-Tech Ueno, commented as follows. "We are pleased to announce the successful completion of a phase 1 clinical study on our self-developed RK-023 that focuses on the dermatology field. We intend to start a phase 2 clinical study in Japan as scheduled and at the same time proceed with full-scale negotiations for partnership at home and abroad."
Having obtained the results of the above-mentioned phase 1 clinical study, we plan to promptly conduct a phase 2 clinical study and accelerate our efforts to develop a drug that will become useful for the patients with androgenetic alopecia as soon as possible.
Note: Androgenetic alopecia:
Due to the influence of male hormones during and after puberty, thick and long hair does not regenerate but is replaced with thin and short soft hair, and consequently the hair follicles become atrophied, reducing the quantity of hair, localized from the parietal to the frontal region.
*About R-Tech Ueno, Ltd.
R-Tech Ueno was established in September 1989 for the purpose of marketing and R&D of drugs. Led by Dr. Yukihiko Mashima, Representative Director and President of R-Tech Ueno, this pharmaceutical venture enterprise has been engaged in the development of new drugs under the theme of "Physician-Oriented New Drug Innovation" and has targeted at ophthalmologic and dermatological diseases against which effective drugs are hard to come by. The company's main product, Rescula(R) eyedrop 0.12%, is a therapeutic drug for glaucoma and ocular hypertension and has been marketed in Japan since 1994. R-Tech Ueno was the first in the world to take advantage of the substance "prostone" in the development of Rescula(R) eyedrop 0.12%. Prostone was discovered in 1980's by Dr. Ryuji Ueno, the founder of the company. Rescula(R) eyedrop 0.12% that causes less topical and systemic adverse reactions demonstrates steady ocular pressure-decreasing action by twice-a-day instillation. Such excellent therapeutic effects are realized through its optic nerve protection and ocular blood flow-increasing mechanism. Concerning Rescula(R) (isopropyl unoprostone) for the treatment of glaucoma and ocular hypertension, R-Tech Ueno concluded a contract with Sucampo Pharma Americas, Inc. in April 2009 for the approval and assignment of distributorship, as well as for licensing the relevant patents and granting exclusive rights to manufacture and supply in USA and Canada.
(1) Open patch test: Open patch dressing to the forearm skin for 48 hours (2) Closed patch test: Closed patch dressing to the back skin for 48 hours (3) Photo-patch test: Closed patch dressing to the back skin for 24 hours, followed by UVA irradiation
SOURCE R-Tech Ueno, Ltd.