RAMAT GAN, Israel--(BUSINESS WIRE)--Obecure has launched a double-blinded, placebo-controlled Phase II clinical trial to evaluate the efficacy of the company’s OBE101 drug candidate in a third indication -- improving the plasma lipid profiles of patients treated with Simvastatin, the most widely prescribed, now generic, cholesterol-lowering drug.

“It is believed that a low fat diet can improve the cholesterol lowering effect of statin therapy in dyslipidemic patients. We believe that OBE101’s anti-fat craving effect may provide the same benefit and assist patients taking Simvastatin, and further lower their plasma lipids,” said Dr. Yaffa Beck, CEO of Obecure.

The beneficial effect of OBE101 in reducing caloric intake, particularly from fatty foods has been observed in a pilot double-blinded placebo-controlled clinical trial conducted in obese women. This effect on food consumption is also the subject of a double-blinded, placebo-controlled trail undertaken by the NICHD division of the National Institutes of Health, which is currently recruiting patients.

The new study will enroll about 30 subjects who are stably treated with Simvastatin and randomize them into one of two treatment groups: a treatment arm, which will be administered the drug twice daily, and a control arm which will receive a placebo. Treatment duration will be 4 weeks and the study will be conducted in 2-3 medical centers in Israel.

The primary endpoints for the study include a statistically significant reduction in LDL levels from baseline in treated patients, as compared to placebo, as well as a significant difference between treatment and placebo in the percentage of patients whose LDL levels are reduced by greater than 10%. Secondary endpoints include reduction in plasma cholesterol, triglycerides, hemoglobin A1c (HbA1c) and ApoE levels, as well as reduction in caloric intake and weight.

Obecure is currently conducting two additional Phase II studies using the company’s OBE101 drug candidate in the area of weight management. The first study, examining OBE101’s efficacy in promoting weight loss in obese patients; has completed enrollment of 281 patients in 20 medical centers in the US. The second is evaluating the drug’s potential in preventing the massive weight gain plaguing patients taking Zyprexa, a highly effective antipsychotic medication, with sales topping $4 billion annually.

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 three indications: (i) general obesity (ii) weight gain associated with anti-psychotic drug therapy and (iii) as adjunct to statin therapy for improving blood lipid profiles. 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., which is traded on the Tel Aviv Stock Exchange (TASE:BOLT)

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