Obecure Completes Treatment of Patients in Phase II Obesity Trial
Obecure announced today that the last patient to be enrolled in the company’s Phase II clinical trial for obesity has completed treatment. The double-blinded, placebo-controlled, dose-ranging study enrolled 281 patients with a BMI ranging from 30-40 at 20 clinical centers across the U.S. Subjects were randomized into one of four treatment arms comparing placebo with 16 mg., 32 mg., and 48 mg. daily doses of the company’s OBE101 drug candidate. Treatment was administered orally, twice daily, for a duration of 12 weeks. The company expects to present top-level results of the trial in the early fall.
“We are pleased to have completed this study ahead of schedule,” said Dr. Yaffa Beck, CEO of Obecure. “We hope that the results will confirm the potential of our drug for weight loss, as observed in a preliminary trial in a small group of obese women.”
Obecure achieved promising results in a double-blind, placebo- controlled preliminary trial involving 20 obese women who were treated for four weeks with a 16 mg. twice daily dose of OBE101. The study showed that subjects in the treatment arm significantly reduced more weight than their placebo counterparts. Moreover, the weight reduction could be attributed to a reduction in their intake of fatty foods.
“We also believe that the results of the Phase II trial will confirm OBE101′s remarkable safety profile, previously established in more than 100 million people treated for its initial approved indication of vertigo,” added Dr. Beck. “The need for an improved safety/efficacy profile for novel anti-obesity drugs was underscored by the FDA advisory committee’s recent recommendation to deny approval of a new anti-obesity drug being developed by a major pharmaceutical manufacturer because of safety concerns.”
Commenting on the pharmacological breakthrough that OBE101 offers in the area of weight management, Dr. Nir Barak, CSO of Obecure, explained: “We are developing a novel approach for weight management, based on the activation of the histaminergic pathway. Such activation should reduce patients’ appetite and especially their craving for fatty foods, thereby helping them lose weight.”
Obecure is currently conducting two additional Phase II studies using OBE101 in the area of weight management. One study is evaluating OBE101′s potential in preventing the massive weight gain plaguing patients taking Zyprexa, a highly effective antipsychotic medication, with sales topping $4 billion annually. The other study is evaluating the efficacy of the company’s OBE101 drug candidate in improving the plasma lipid profiles of patients treated with Simvastatin. Simvastatin is the most widely prescribed cholesterol-lowering drug and is manufactured generically.
In addition, the NICHD division of the National Institutes of Health is currently conducting a double-blinded, placebo-controlled study to examine OBE101′s mechanism of action and its effect on food consumption and expenditure. It is currently recruiting patients for the study.
About OBE101
OBE101 is comprised of betahistine, approved and marketed worldwide, except in the United States, for the treatment of Meniere’s disease (vertigo). Obecure is repurposing betahistine, which is an H1 receptor agonist and partial H3 receptor antagonist for the treatment of obese individuals and for other weight management indications. Betahistine has an excellent safety profile and has been used for treatment by more than 100 million patients suffering from vertigo and dizziness.
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., an investment company, traded on the Tel Aviv Stock Exchange (TASE:BOLT)