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Obecure Recruits First Patient in Phase II Obesity Study

Posted on: Wednesday, 24 January 2007, 09:01 CST

Obecure has commenced its first Phase II clinical trial to evaluate the efficacy of the company's OBE101 drug candidate for weight loss in obese patients. The study is a double-blinded, placebo-controlled dose-ranging study in about 280 subjects over a period of three months. The study will be carried out at 20 medical sites across the U.S.

"There is a great unmet need for a safe and effective therapy that can control weight," said Yaffa Beck, CEO of Obecure. "Our preliminary human study demonstrates that OBE101, comprised of betahistine, offers a promising new approach to meet that need. Betahistine has a proven safety profile and has been shown to be effective in weight reduction in pilot studies."

Betahistine is currently marketed in many countries for the treatment of vertigo. The drug was first approved in the mid 1960's but was taken off the U.S. market by the FDA for lack of clinical evidence in that indication. Notably, no safety issues were raised and a recent post-marketing survey, citing worldwide treatment of more that 100 million patients, shows that the drug has a remarkable safety profile.

The idea for using betahistine in weight management is based on breakthrough research carried out in obese patients by Dr. Nir Barak, a nutritional and internal medicine expert who serves as Obecure's Chief Scientific Officer. The technology is protected by worldwide patent-pending applications including in the U.S. where betahistine is unavailable for any indication.

Dr. Barak's research successfully demonstrated the key role that histamine receptors play in controlling appetite and food consumption and the beneficial effect that activating these receptors can have in suppressing the desire for fat consumption. In a double-blinded pilot study, involving 20 human subjects over four weeks, OBE101 reduced both calorie and fat intake in the treatment group, resulting in significant weight loss versus placebo.

In an independently conducted study, betahistine was also shown to successfully counteract the blocking of the histamine receptor and the weight gain that is associated with the use of an antipsychotic medication. In view of these findings, the company is also planning a Phase II clinical trial with the support of Eli Lilly & Co. to examine if OBE101 administered to patients in combination with the antipsychotic drug Zyprexa (olanzapine) can prevent the weight gain associated with the latter. The trial, which has received the approval of Health Canada, is expected to start in the spring of 2007.

In addition, the U.S. National Institute of Health (NIH) has agreed to undertake a study comprising 80 human subjects, that will examine the drug's mechanism of action involved in weight control.

Obecure has recently retained the services of Rodman & Renshaw to assist the Company with its first private placement in the U.S.

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 OBE101 for two indications: (i) general obesity and (ii) weight gain associated with anti-psychotic drug therapy. In addition, the Company is evaluating additional proprietary analogues for both weight gain and weight loss in preclinical models.

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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