Manhattan Gets Approval for Obesity Drug Trial

Manhattan Pharmaceuticals received Swiss regulatory approval to begin its Phase IIa study with oral Oleoyl-estrone (OE), the company’s drug candidate for the treatment of obesity. The single center, Phase IIa study is a randomized, double-blind, placebo-controlled, parallel group study designed to evaluate the safety, preliminary efficacy, and pharmacokinetics of two 14-day dosing cycles in obese adult subjects. Subjects will be randomly enrolled in one of four treatment groups. Dose levels of OE will be placebo, 5, 10, or 20 mg taken once daily. Each 14-day dosing cycle will be followed by a 28-day treatment free evaluation period.

OE is an orally administered, synthetic form of Oleoyl-estrone, a molecule that exists naturally in the body. Results of the Phase I trials with OE showed the compound was well tolerated. Subjects in the Phase Ib study experienced weight loss as well as beneficial changes in blood glucose and cholesterol levels. There was also evidence of OE offering the potential for sustained weight loss after dosing with OE stopped. Clinical laboratory findings included reversible, dose-dependent elevations in estrone and estradiol levels, as well as reductions in testosterone levels.