Obecure Ltd announced the completion of enrollment in its Phase IIb clinical trial, BET-207, evaluating the safety and efficacy of Histalean™ for weight loss in obesity. 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 =50 years, treated with 48 mg/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 (BMI) ranging from 30 to 40 Kg/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™ 96 mg, Histalean™, Histalean™ 48 mg or matching placebo, for a total duration of 12 weeks.
“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," commented Dr. Yaffa Beck, CEO of Obecure, adding that "We anticipate that the results of the study will be available towards the end of Q2 2009."
"The regulatory authorities' sensitivity to safety issues, may be the primary advantage of Histalean™," said Dr. Nir Barak, the company's CSO and inventor of this new anti-obesity approach.
"The active ingredient in Histalean™ is betahistine, a known histaminergic effector, with an excellent safety profile, established in more than 130 million human exposures. Hence, we anticipate that once we show efficacy, this safety will render it highly attractive, either as standalone monotherapy, or in combination with other anti-obesity drug classes."
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 NIH under IND and supported by Obecure.