Obecure Completes Patient Enrollment For Its Confirmatory Phase IIb Trial With HistaleanTM In Obesity
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 HistaleanTM 96 mg, HistaleanTM, HistaleanTM 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 HistaleanTM 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."
Obesity is one of the biggest health crises largely underserved. Current drug therapies, dominated by generic phentermines and the more recent Meridia® and Xenical®, are only moderately effective and are limited by safety and tolerability concerns. Safety, particularly psychiatric side effects, has also led to non-approval of Accomplia®, and struck a death blow to the entire CB1 inhibitor drug class.
"The regulatory authorities' sensitivity to safety issues, may be the primary advantage of HistaleanTM," said Dr. Nir Barak, the company's CSO and inventor of this new anti-obesity approach. "The active ingredient in HistaleanTM 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.
Histalean™ is comprised of betahistine, approved and marketed worldwide, except in the United States, for the treatment of Meniere's disease (vertigo). Obecure is repurposing betahistine, which is an H1 receptor agonist and partial H3 receptor antagonist, both for the treatment of obese individuals, and for attenuating drug associated side effects, such as weight gain associated antipsychotic drugs' histamine inhibition. Betahistine has an excellent safety profile and has been used since the 1960s in patients suffering from vertigo and dizziness.
The use of betahistine for weight management, alone or in combinations, is protected by pending patents, filed worldwide, and exclusively licensed to Obecure by Mor Research Applications Ltd., the Technology Transfer Office of Clalit HMO.
Obecure Ltd., a subsidiary of Bio-Light Israeli Life Science Investments Ltd., publicly traded on the Tel Aviv Stock exchange (TASE:BOLT), is a private biopharmaceutical company dedicated to the development of weight management drug therapies.