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R-Tech Ueno: Announcement on Completion of the Phase I Single-Dose Clinical Trial for the Novel VAP-1 Inhibitor RTU-1096

2015年05月25日 PM03:50
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TOKYO

R-Tech Ueno (JASDAQ: 4573)

We are pleased to announce that the phase I single-dose clinical trial for the new molecular entity RTU-1096 has been completed. RTU-1096 is a vascular adhesion protein-1 (VAP-1) inhibitor having anti-inflammatory and immunomodulatory effects. The descriptions of the trial result are as follows:

The company has been developing an anti-inflammatory drug with a new mechanism of action based on VAP-1 inhibitory effect. We are currently conducting the phase I clinical trial for the oral agent of a new molecular entity (Development Code: RTU-1096), which is targeted at healthy adult males. Recently, the single-dose trial, which is the first trial stage, has been completed. The trial intended to examine the safety, tolerability, and pharmacokinetics of RTU-1096 in a single dose. The trial was conducted as a placebo-controlled double-blind study, and investigational drugs were administered to 40 subjects in total. All subjects completed the full administration period without any cases of discontinuation. Five adverse events in five subjects, including the placebo group, were reported, however, none of them were regarded as causally related to the investigational drug, nor determined as the side effect. Accordingly, safety and tolerability of RTU-1096 up to the highest dose have been confirmed. Furthermore, serum VAP-1 activity of each subject was measured in this trial, and the result showed significant reduction in serum VAP-1 activity of all subjects, from low-dose group to high-dose group, immediately after the administration of RTU-1096. Its effect lasted longer, and the reduced serum VAP-1 activity has recovered gradually.
Based on these results, we have decided to proceed to the repeated dose clinical trial of RTU-1096 as scheduled, and have initiated the preparation of this trial. This repeated dose trial will also evaluate safety, tolerability, pharmacokinetics, and the effect on serum VAP-1 activity of RTU-1096.

Yukihiko Mashima, MD, PhD, President of the company, has stated the following:
“This VAP-1 inhibitor RTU-1096 is an agent that is First in Class (First-in-Human use). We are very pleased that the trial result confirmed the safety of RTU-1096 up to the highest dose. In addition, the trial data indicated significant and sustained reduction in serum VAP-1 activity after once-daily low-dose administration of RTU-1096. This data is also quite useful for our future clinical development. Going forward, we will carry out the repeated dose trial of RTU-1096 to further evaluate its safety and to determine its appropriate dosing regimen in Phase II study.”

The above venture will not contribute to any revisions to the earnings forecasts of the second cumulative quarter and the full year previously announced on May 14, 2015.

For full details of the press release, please visit:
http://www.rtechueno.com/en/investor/press/documents/150525_pr_en.pdf

View source version on businesswire.com: http://www.businesswire.com/news/home/20150524005057/en/

CONTACT

R-Tech Ueno, Ltd.
Koji Nakamura, +81-3-3596-8011
Director
Business
Management Department
info@rtueno.co.jp

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