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Shionogi Announces Positive Top-Line Efficacy Results from Year-Long Studies of Velneperit, a Novel NPY Y5 Receptor Antagonist Being Investigated for the Treatment of Obesity
Date:2/17/2009

OSAKA, Japan and FLORHAM PARK, N.J., Feb. 17 /PRNewswire/ -- Shionogi & Co, Ltd. today announced that two distinct year-long studies of velneperit, a novel neuropeptide Y (NPY) Y5 receptor antagonist also known as S-2367, each met their primary endpoint of demonstrating a statistically significant reduction in body weight. These clinical studies further demonstrate the potential for the NPY Y5 receptor as a target for obesity treatment.

Shionogi assessed the long term efficacy and safety of velneperit over the course of one year in two distinct studies, comprising a total randomized population of 1,566 obese subjects across 80 centers in the United States. Each respective study assessed the efficacy and safety of velneperit under different reduced calorie diet and low calorie diet conditions. In the strongest performing group relative to placebo across the two studies, subjects undergoing velneperit treatment of 800mg once-daily in combination with a reduced calorie diet responded with 5% or greater weight loss at a percentage nearly three times higher than those on placebo (35% vs. 12%). In addition, velneperit treatment resulted in statistically significant differences with respect to secondary parameters such as decreased waist circumference and improved serum lipid profile. In terms of safety, velneperit was well tolerated in all groups over the course of one year treatment, a finding consistent with subject experience in previous clinical studies. A full analysis of the current study data, including secondary efficacy endpoints as well as safety and laboratory parameters is currently underway.

Study Design and Results

Two distinct double-blind, placebo controlled trials were employed to examine the safety and effectiveness of long-term velneperit treatment under different diet conditions. The unique mechanism of action of velneperit involves blocking the Y5 binding receptor for neurope
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SOURCE Shionogi & Co., Ltd.
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