NEUROGEN BEGINS TRIAL OF OBESITY DRUG

Neurogen announced it has begun Phase I human testing of its leading drug candidate for treatment of obesity. The compound, NGD-4715, works as an antagonist at the melanin-concentrating hormone receptor-1 (MCH1).

The ongoing Phase I clinical trial is a randomized, double-blind, placebo-controlled evaluation in overweight and obese subjects of the safety, pharmacokinetics and pharmacodynamics of single rising oral doses of NGD-4715. The study has a planned total enrollment of up to 84 male and female subjects. This single-center study will be conducted in the U.S., and standard safety assessments will be made.

Neurogen's obesity program is focused on blocking MCH1. When the neuropeptide MCH binds to the receptor it stimulates food intake. Reported studies in rodents support MCH being an important mediator of caloric intake. Deletion of MCH or the MCH1 receptor gene resulted in lean animals, while over-production of MCH caused increased weight gain. Neurogen scientists presented data in 2004 that the company believes were the first reported findings of the utility of an MCH1 antagonist in a non-rodent species. The company's studies indicated that selectively blocking MCH1 was sufficient to achieve a significant reduction in food intake in a higher animal species.

"While the MCH1 mechanism has been a target of high interest in the pharmaceutical community, we believe most in the industry have encountered significant obstacles to advancing drug candidates into human studies," William Koster, president and CEO of Neurogen, said.