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
“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.
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