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Obecure Recruits First Patient in Phase II Obesity Study in Pre-Menopause Women

Posted on: Monday, 8 September 2008, 09:00 CDT

Obecure has commenced a Phase II clinical trial to evaluate the efficacy of Histalean(TM) in obese patients. This study, encoded BET-207, is a follow-up to the Company's post-hoc findings in a prior Phase II study, suggesting that treatment with a 48 mg/day dose of the drug provides significant weight reduction in obese women up to the age of 50. The current study is a double-blinded, placebo-controlled, multi-center, dose ranging study to confirm the efficacy of a 12 week treatment with the drug in obese but otherwise healthy premenopausal females aged 18-50. The study will randomize about 180 obese women, with a body to mass ratio (BMI) ranging from 30 - 40 kg/m2, into three study arms: 60 women will be treated with 48 mg/day Histalean(TM), 60 women will be treated with 96 mg/day Histalean(TM) and 60 women will receive matching placebo. The study will be carried out in about 12 investigation sites in Europe and regulatory approval has already been received in Belgium and the Netherlands.

The current obesity epidemic represents a growing health hazard for more than 400 million obese individuals worldwide, placing them in risk of contracting serious and life-threatening illnesses such as diabetes and cardiovascular disease. According to the Center for Disease Control, obesity, defined as having a BMI greater than 30 kg/m2, afflicts about 1/3 of the adult population and results in total economic burden in excess of $100 billion. Based on the recognition that obesity is a disease, pharmacological intervention has been gaining wider acceptance. However, the few drugs currently available are only moderately effective and/or show adverse side effects, which greatly limit their acceptance. Hence there is a greatly unmet need for innovative therapeutic approaches.

According to Dr. Yaffa Beck, Obecure's Chief Executive, "Histalean(TM) may provide exactly such a solution". "It is based on a very well known drug with an excellent safety profile, which was established in over 40 years of use in more than 100 million patients, and targeting histamine - a key neurotransmitter by which the brain controls appetite and eating" she adds.

"We attribute the drug's potential for weight management, particularly in obese women of child-bearing age, to its direct effect on the histamine H1 receptor system, which has demonstrates improved response in the presence of female hormones" said Nir Barak M.D., Chief Scientific Officer of Obecure. "The purpose of this study, BET207, is to confirm our previous findings and to optimize drug dosage in women", he added.

"We view women's health as a growing need and hope that a drug as benign as Histalean(TM) will offer a promising new approach to meet that need in obese women " emphasized Dr. Beck adding that "According to the Center for Disease Control, about 32% of adult American women under 54 (about 25 million women) suffer from obesity".

Obecure is also pursuing the use of Histalean(TM) for preventing the massive weight gain plaguing patients taking olanzapine (Zyprexa), a highly effective antipsychotic medication. The weight gain has been mainly attributed to the anti-histaminic effect of olanzapine in patients' brain and may thus be offset by histaminergic activation. The Company is therefore conducting a clinical trial in eight investigation sites across Canada and in Israel to evaluate the potential of Histalean(TM) to attenuate the deleterious effect of co-administered Zyprexa. It is notable that Eli Lilly, manufacturer of Zyprexa, is providing research support to Obecure for conducting this trial.

In addition, the U.S. National Institute of Health (NIH) has undertaken and is conducting a study to examine the drug's mechanism of action and effect on energy balance (consumption and expenditure) in overweight women.

About Histalean(TM)

Histalean(TM) is comprised of betahistine, approved and marketed worldwide for the treatment of Meniere's disease (vertigo). The drug is not available in the U.S, since its withdrawal by the FDA in 1972 for lack of efficacy data (No question of safety was raised). Betahistine is a histamine-like drug, but unlike histamine it is centrally acting and only has an H1 receptor agonist and partial H3 receptor antagonist activity with no affinity to the H2 histamine receptor; thus explaining its relative safety in more than 130 million human exposures to-date.

About Obecure

Founded in 2005, Obecure Ltd. is a biopharmaceutical company dedicated to the development of weight management drug therapies. The Company is currently pursuing the clinical development of its lead compound Histalean(TM) for general obesity and for weight gain associated with anti-psychotic drug therapy.

Obecure has a worldwide exclusive license from Mor Research Applications Ltd., the Technology Transfer Office of Clalit HMO to clinically develop and commercially exploit the technology, as developed by Dr. Nir Barak, a specialist in nutrition and internal medicine at the Rabin Medical Center in Tel Aviv.

Obecure is a subsidiary of Bio-Light Life Science Investments Ltd., an investment company, traded on the Tel Aviv Stock Exchange (TASE:BOLT).

Source: Business Wire

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