OREXIGEN(TM) Therapeutics To Present First Clinical Results For Contrave(TM) To Treat Obesity
09 Jun 2006
OREXIGEN(TM) Therapeutics, Inc., a privately held clinical-stage neuroscience company developing a novel strategic approach to the treatment of obesity, today announced that the company's lead program, Contrave(TM), has shown positive results in Phase II clinical studies and is now being assessed in Phase III trials. Contrave and a companion clinical program Excalia(TM) are rationally formulated, proprietary combinations of marketed CNS products. They are based on innovative approaches to the treatment of obesity that apply OREXIGEN's proprietary approach to drug screening combined with the company's knowledge of how the brain regulates appetite, energy expenditure, food cravings, and in turn, body weight.
Top line Phase II data for Contrave will be presented by Frank Greenway, M.D., chief of the Clinical Obesity Laboratory and Outpatient Research Clinic at the Pennington Biomedical Research Center, and discussed concurrently in a plenary session, "Obesity Treatment: Behavioral vs. Pharmacological vs. Surgical Approaches," by Louis Aronne, M.D., Clinical Professor of Medicine at Weill Cornell University Medical College and director of the Comprehensive Weight Control Program at New York Presbyterian Hospital-Weill Cornell Medical Center, at the upcoming annual Scientific Sessions of the American Diabetes Association, Saturday at 10 am.
"OREXIGEN's unique approach to the treatment of obesity reflects the key role of the central nervous system in the regulation of appetite, food intake and weight," said OREXIGEN President and CEO, Gary Tollefson, M.D., Ph.D. "We approach obesity as a clinical condition in which the central nervous system contributes significantly to the development and persistence of weight gain. Specifically the science we are applying in our late stage Contrave program seeks to address mild to moderate obesity -- often with food cravings -- whereas our Excalia program is targeted at moderate to severe obesity which is often associated with medical complications."
Both of OREXIGEN's clinical programs are new formulations of proprietary combinations of CNS drugs that target specific pathways intended to achieve distinctive weight loss profiles. The company's underlying preclinical research suggests that combinations may be more effective than monotherapy in both promoting and sustaining weight loss. OREXIGEN leverages its proprietary science to rapidly screen candidate combinations to determine which formulations demonstrate the optimal balance and synergistic activity needed to advance to the clinic. In addition to its proprietary science, the company's approach is protected by broad patent filings around composition, use and formulations.
Dr. Tollefson added, "In addition to our distinctive scientific approach, OREXIGEN's unique business model combining novel proprietary screening with repurposed drugs is enabling us to reduce the time needed to progress to commercialization and reduce our development costs, at the same time that it increases our technical probability of success." OREXIGEN has raised more than $45 million from leading venture investors since its founding in 2003.
"Despite epidemic rates of obesity, few people seek drug therapy, possibly because, as published reports indicate, currently approved regimens help individuals achieve only modest weight loss, which then stalls at a plateau," said OREXIGEN chief scientist Michael Cowley, Ph.D. "By contrast, our approach is uniquely intended to achieve and sustain weight loss by enhancing satiety, diminishing appetite, improving energy expenditure and minimizing the body's efforts to compensate for weight loss."
Obesity is associated with a heightened risk for a number of medical problems including cardiovascular disease, type II diabetes, sleep disorders and a shortened life expectancy According to the Centers for Disease Control, two thirds of American adults are overweight and thirty percent are obese, meaning they are more than 20% over their ideal weight. In the United States the number of obese people is projected to reach 82 million Americans in the next five years.
OREXIGEN(TM) Therapeutics, Inc.
Obesity Drug 
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