Obecure completes enrollment in Phase IIb obesity trial

The double-blinded, randomized, placebo-controlled, dose ranging study is designed to evaluate the drug in about 180 pre-menopause obese women. The study is intended to confirm and extend previous Phase II findings suggesting strong gender and age dependence and a significant response in females, aged less than or equal to 50 years, treated with 48mg/day Histalean.

The co-primary endpoints for these studies are the mean percent weight loss and the percentage of subjects achieving weight loss of 5% or more.

Study BET-207 is being concurrently conducted in 15 investigation sites across Germany, Belgium and the Netherlands. Out of more than 250 patients screened 180 pre-menopause, women with a body mass index ranging from 30 to 40Kg/m2 that fulfilled all inclusion and exclusion criteria, were randomly assigned in a double-blinded fashion into three groups and orally treated twice a day with Histalean 96mg, Histalean, Histalean 48mg or matching placebo, for a total duration of 12 weeks.

The effect of betahistine on food consumption and energy expenditure is concurrently being elucidated in a randomized, double-blinded, placebo-controlled, dose ranging study at the National Institutes of Health under investigational new drug and supported by Obecure.

Yaffa Beck, CEO of Obecure, said: The rapid pace of patient enrollment in this trial reflects an outstanding effort of our investigators clinical team and illustrates the large need for new approaches to obesity treatment, especially now that the CB1 class of therapeutics seems to have been abandoned as a treatment for obesity.

This brings us one step closer towards our goal of validating Histalean as a pioneer of a novel anti-obesity drug class based on histamine activation. We anticipate that the results of the study will be available towards the end of second quarter of 2009.