R-Tech Ueno: Announcement on Completion of the Phase I Single-Dose Clinical Trial for the Novel VAP-1 Inhibitor RTU-1096
May 25 2015 - 2:50AM
Business Wire
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
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version on businesswire.com: http://www.businesswire.com/news/home/20150524005057/en/
R-Tech Ueno, Ltd.Koji Nakamura, +81-3-3596-8011DirectorBusiness
Management Departmentinfo@rtueno.co.jp