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www.fdanews.com/articles/89721-vernalis-initiates-study-of-drug-for-obesity-type-2-diabetes

VERNALIS INITIATES STUDY OF DRUG FOR OBESITY, TYPE 2 DIABETES

December 12, 2006

Vernalis has begun a Phase I trial of V24343, a cannabinoid type 1 (CB1) antagonist, as a potential treatment for obesity, Type 2 diabetes and related disorders.

CB1 is widely expressed both in peripheral tissues involved in lipid and glucose metabolism and in the brain regions controlling appetite. Blockade of these receptors by selective CB1 receptor antagonists causes weight loss and ameliorates risk factors for obesity related disorders such as cardiovascular disease and Type 2 diabetes. The efficacy of CB1 receptor antagonists in the treatment of obesity, Type 2 diabetes and associated disorders has been clinically demonstrated in recent trials of rimonabant, according to the company.

The Phase I double-blind, randomized, placebo-controlled study in overweight and mildly obese volunteers will be conducted in two parts, a single ascending dose followed by a multiple ascending dose, and is expected to complete in mid-2007. The primary objectives of the Phase I program are to evaluate the safety, tolerability and pharmacokinetics of single and multiple doses of V24343; however, having overweight and mildly obese subjects in the trial ensures that the evaluation of V24343 is carried out in clinically relevant subjects.