OBECURE BEGINS PATIENT RECRUITMENT IN OBESITY STUDY

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

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

Obecure's research has 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 to examine if OBE101 administered to patients in combination with the antipsychotic Zyprexa (olanzapine) can prevent the weight gain associated with the drug.

In addition, the NIH has agreed to undertake a study involving 80 human subjects that will examine the drug's mechanism of action involved in weight control.