SAN DIEGO, May 22 /PRNewswire-FirstCall/ -- Orexigen Therapeutics, Inc. , a biopharmaceutical company focused on the treatment of central nervous system disorders, with an initial focus on obesity, today announced the initiation of the second study in its Phase III clinical trial program for its lead product candidate Contrave(TM) as a treatment for obesity. The program includes a set of four registration trials evaluating a variety of obesity-related outcome measures.
This trial is a 56-week study intended to assess both the safety and efficacy of Contrave in obese subjects who also manifest type II diabetes. Recent studies have demonstrated that obesity is a leading risk factor for various metabolic disorders, such as diabetes, and this trial will evaluate both weight loss as well as several factors related to glucose metabolism. The trial will take place at approximately 40 centers nationwide and OREXIGEN plans to enroll approximately 525 individuals. Patient recruitment is now underway. Please see http://www.clinicaltrials.gov for more information.
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. OREXIGEN chose these two constituent drugs based on the results of its model used to screen potential drug combinations and OREXIGEN’s understanding of circuitries in the brain that regulate appetite and energy balance. In a previous Phase IIb multi-center clinical trial, Contrave demonstrated statistically significant weight loss at 48-weeks compared to bupropion SR alone, naltrexone IR (immediate release) alone, and placebo.
“Contrave is a unique approach to weight loss based on our understanding of the central nervous system,” said Gary Tollefson, M.D., Ph.D., OREXIGEN president and CEO. “Contrave has been shown to activate central pathways associated with both a reduction in appetite and an increase in the expenditure of energy, while blocking the body’s attempts to curtail overall weight loss. This latter phenomenon has been referred to as the classic ‘diet plateau.’” In addition, Dr. Tollefson indicated that the company also has preliminary evidence that Contrave may positively affect risk factors associated with type II diabetes.
In April, OREXIGEN initiated enrollment in its first Phase III clinical trial, a 56-week study intended to help evaluate Contrave’s weight loss potential alone or when combined with intense diet, exercise and behavior modification. The study is taking place at nine centers nationwide and plans to enroll approximately 800 subjects.
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 a Phase III clinical trial, and Empatic(TM) (formerly Excalia(TM)), which is in a Phase IIb clinical trial. Both product candidates take advantage of recent understandings of how the brain appears to regulate our appetite and energy expenditure, and sustained weight loss, as well as mechanisms that come into play to limit the amount of potential weight loss. 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 efficacy of Contrave for the treatment of obesity or its potential to affect risk factors associated with type II diabetes may be 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: OREXIGEN’s Phase III clinical trials may not proceed in the timeframes or in the manner OREXIGEN expects or at all; the results of earlier clinical trials may not be predictive of future results; the scientific theories relating to the central nervous system on which OREXIGEN has based its development programs may not result in product candidates with sufficient efficacy or safety to obtain regulatory approval or commercial success; we and our licensors may not be able to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of our 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: Graham Cooper Stephen Gendel 858 436-8600 BioCom Partners 212 918-4650
Orexigen Therapeutics, Inc.
CONTACT: Graham Cooper of OREXIGEN, +1-858-436-8600; or Media: StephenGendel of BioCom Partners, +1-212-918-4650
