SAN DIEGO and CHICAGO, June 23 /PRNewswire-FirstCall/ -- Orexigen(TM) Therapeutics, Inc. , a biopharmaceutical company focused on the treatment of central nervous system disorders with an initial focus on obesity, today announced that data from a sub-study of its Phase IIb multi- center clinical trial of Contrave(TM) demonstrated robust improvements in both visceral fat and insulin resistance.
Contrave is a proprietary fixed dose combination of bupropion SR (sustained release) and Orexigen's novel formulation of naltrexone SR in a single tri-layer tablet. Contrave is designed to act on neurons in the brain with the goal of achieving appetite suppression, decreased food craving, and sustained weight loss.
Across the three Contrave arms, the mean reduction in visceral fat ranged from 13.7% to 16.7% after 24 weeks of treatment compared to a mean 4.6% reduction among the placebo group. Moreover, the effect of Contrave was substantially larger than that seen with either of Contrave's individual components when given alone. Visceral fat is located inside the abdominal cavity and surrounds vital organs such as the liver. Visceral fat accumulation, as opposed to subcutaneous fat which is found just underneath the skin, is associated with increased risk of heart disease and Type II diabetes.
Additional findings from this sub-study of 107 obese subjects revealed that Contrave improved measures of insulin resistance and demonstrated a positive impact on a number of other risk factors including triglycerides, cholesterol, and blood sugar. Together, such improvements hold potential for longer term health benefits.
"These clinical findings suggest the weight loss associated with Contrave also included a substantive loss in visceral fat. This is important for both patients and physicians because of the well-recognized link between visceral fat, diabetes and heart disease," said Gary Tollefson, M.D., Ph.D., Orexigen President and CEO. "We believe that Contrave may represent an important new weapon in the treatment of obesity, not only for the weight loss it appears to produce, but also for its potential impact on the behavioral and metabolic sequelae associated with obesity."
"The effect of Contrave on markers of insulin resistance is a novel observation that has potential to demonstrate a greater level of pharmacological synergy than had been anticipated," said Frank Greenway, M.D., Principal Investigator of the study and Professor and Chief of the outpatient department at the Pennington Biomedical Research Center in Baton Rouge. "In this study, the effect of Contrave on insulin resistance and other metabolic factors was superior to what was seen with placebo, bupropion, or naltrexone alone."
Contrave is now being studied in two separate multi-center Phase III studies, one of which is designed to assess its safety and efficacy in obese subjects with Type II diabetes.
Data on the effect of Contrave on visceral fat and insulin resistance will be presented at the ADA 67th Scientific Sessions on Saturday, June 23rd, 6:00- 7:15pm and Monday, June 25th, 12:00-2:00pm in Chicago (IL). Contrave data can be found in category 20B, poster number 45LB entitled, "Weight Loss with Bupropion and Naltrexone Improves Markers of Insulin-Resistance."
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the development of pharmaceutical product candidates for the treatment of central nervous system disorders, with an initial focus on obesity. Orexigen's lead combination product candidates targeted for obesity are Contrave(TM), which is in Phase III clinical trials, and Empatic(TM) (formerly Excalia(TM)), which is in a Phase IIb clinical trial. Both product candidates take advantage of the Company's understanding of how the brain appears to regulate appetite and energy expenditure, as well as the mechanisms that come into play to limit weight loss over time. Each product candidate is designed to act on a specific group of neurons in the central nervous system with the goal of achieving appetite suppression and sustained weight loss. Further information about the Company can be found at http://www.Orexigen.com.
Forward Looking Statements
Orexigen cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Orexigen that any of its plans will be achieved. For example, statements regarding the potential of Contrave(TM) to produce weight loss and achieve longer term health benefits for metabolic syndromes associated with obesity such as heart disease and diabetes are forward looking statements. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Orexigen's business, including, without limitation: the results of this Phase IIb clinical trial and earlier clinical trials may not be predictive of future results; Orexigen's pending clinical trials may not proceed in the timeframes or in the manner Orexigen expects or at all; unexpected findings relating to Contrave(TM) or Empatic(TM) that could delay or prevent regulatory filings, approval or commercialization, or that could result in recalls or product liability claims; Orexigen and its licensors may not be able to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of its product candidates; and other risks detailed in Orexigen's public filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Orexigen undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
CONTACTS: OREXIGEN MEDIA INVESTORS Graham Cooper Stephen Gendel Jason Spark 858 436-8600 212 918-4650 619 849-6005
Orexigen Therapeutics, Inc.CONTACT: Graham Cooper of Orexigen Therapeutics, Inc., +1-858-436-8600; orMedia, Stephen Gendel, +1-212-918-4650, or Investors, Jason Spark,+1-619-849-6005
Web site: http://www.Orexigen.com//
