Obecure completes patient treatment in obesity trial

Drug maker Obecure has completed the treatment of patients in its phase II obesity trial. The company expects to present top-level results of the trial in the early fall.

The double-blinded, placebo-controlled, dose-ranging study enrolled 281 patients with a BMI ranging from 30-40 at 20 at clinical centers across the US. 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.

Obecure says it achieved promising results in a 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,” Dr Nir Barak, CSO of Obecure, said. “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.”

The company is 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, an antipsychotic medication. The other study is evaluating the efficacy of the company’s OBE101 drug candidate in improving the plasma lipid profiles of patients treated with cholesterol-lowering drug simvastatin.