San Diego, CA, 11:00 am EDT, October 22, 2006 OREXIGENTM Therapeutics, Inc., a privately held clinical-stage neuroscience company developing novel strategic approaches to the treatment of obesity, today announced that ExcaliaTM, a combination of two centrally-acting medications intended to provide and sustain clinically important weight loss, demonstrated significant weight loss in a six month, double-blind, phase IIa clinical study. The magnitude of weight reduction exceeded that seen with placebo. The findings showed that patients completing the blinded 24-week phase lost on average 9.2% of their weight from baseline using Excalia compared to an average of 0.4% weight loss from baseline for patients using placebo. The study results further demonstrate that weight loss continued through an additional 24 week open-label period achieving an average weight loss of 12% from baseline by 48 weeks. These top line phase IIa data for Excalia were presented at the annual meeting of the North American Association for the Study of Obesity (NAASO) in Boston.
"Excalia is designed to achieve an aggressive weight loss trajectory and then to delay the typical weight loss 'plateau' by offsetting one of the body's natural compensatory pathways. These phase II data suggest a level of efficacy that exceeded our expectations in relation to existing approaches," said Gary Tollefson, M.D., Ph.D., OREXIGEN president and CEO. "Excalia is designed to act on a specific reciprocally paired group of hypothalamic neurons that we believe will yield a clinically meaningful weight loss trajectory among significantly overweight individuals. We believe that these positive data support our theoretical approach."
Excalia is a proprietary combination of bupropion, a dopamine and norepinephrine reuptake inhibitor, plus zonisamide, an approved anticonvulsant medication. OREXIGEN's preclinical research suggests that combining these two central nervous system d
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