Obecure Completes Patient Enrollment for Phase II Obesity Trial
Posted on: Wednesday, 11 April 2007, 09:00 CDT
Obecure has completed enrollment of patients for its Phase II clinical trial to evaluate the efficacy of the company's OBE101 drug candidate for weight loss in obese patients. The double-blinded, placebo-controlled dose-ranging study is being conducted at 20 medical sites across the U.S.
Out of more than 520 patients screened, 281 were recruited and randomized into one of the four treatment groups: placebo, 16 mg., 32 mg., and 48 mg. daily doses. The drug is administered orally, twice daily, for a duration of 12 weeks.
The study was conducted in order to extend the Company's preliminary observations that treatment of obese women with OBE101 for 4 weeks substantially reduced their fatty food intake and improved their weight loss, as compared to their control counterparts, treated with placebo.
"We are delighted with the rapid and efficient way in which the patient recruitment took place since its initiation in late January. We are currently looking forward to the successful completion of the trial in three months and hope to announce the results in the fall of this year, well ahead of our schedule," said Dr. Yaffa Beck, CEO of Obecure.
Earlier this month Obecure announced the initiation in Canada of its second Phase II clinical trial to evaluate the efficacy of OBE101 in prevention of the massive weight gain associated with Zyprexa, (olanzapine) an antipsychotic medication. The double-blinded, placebo-controlled, multicenter trial, is being conducted in Canada and Israel in about 78 subjects who will be treated for a period of four months. The study has been granted partial financial support from Eli Lilly & Co., the manufacturer of Zyprexa.
In addition, the U.S. National Institute of Health (NIH) has agreed to undertake a study comprising 80 human subjects that will examine OBE101's mechanism of action by evaluating its impact on body energy consumption and expenditure.
OBE101 is comprised of betahistine, a known drug approved in many countries outside the U.S. for the treatment of Ménière's disease (vertigo). On the market for many years, the drug has a remarkable safety profile as indicated in a recent post-marketing survey that cited worldwide treatment of more that 100 million patients.
OBE101's use of betahistine for weight management, alone or in combinations, is protected by patent-pending applications worldwide including in the U.S.
About OBE101
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.
Dr. Barak's research successfully demonstrated the key role that histamine receptors and OBE101 play in controlling appetite and 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 statistically significant weight loss versus placebo.
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 and (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., an investment company, traded on the Tel Aviv Stock Exchange (TASE:BOLT).
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
Source: Business Wire
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