|
Ramat Gan, Israel, January 20, 2009
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 screened180
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 doubleblinded
fashion into three groups and orally treated twice a day with HistaleanTM 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".
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 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.
About Histalean™
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
1960's 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.
About Obecure
Obecure Ltd., a subsidiary of Bio-Light Israeli Life science Investments Ltd.,
publically traded on the Tel Aviv Stock exchange (TASE:BOLT), is a private
biopharmaceutical company dedicated to the development of weight management
drug therapies.
For more information visit www.obecure.com or contact:
Yaffa Beck, CEO
Obecure Ltd.
5-7 Shoham St.
Ramat Gan, Israel 52521
Tel: +972-3-7534100
yaffa@bio-light.co.il |
