SAN DIEGO--(BUSINESS WIRE)--Orexigen® Therapeutics, Inc. (Nasdaq: OREX - News), a biopharmaceutical company focused on the treatment of central nervous system disorders, including obesity, today announced completion of enrollment in NB-303 and NB-304, the final two Phase III clinical trials for Contrave®, its lead obesity product candidate. Today’s announcement marks the completion of patient enrollment for the full Contrave Phase III program, keeping Contrave on track for an NDA submission to the FDA in late 2009. The Contrave clinical development program includes four Phase III clinical trials evaluating a variety of obesity and metabolic-related outcome measures. Orexigen previously announced that enrollment was completed in NB-301 and NB-302.
NB-303 is a placebo-controlled, 56-week clinical trial designed to analyze the efficacy, safety and tolerability of Contrave at the expected standard dose with the opportunity for patients to switch to a higher dose if they do not respond after 28 weeks of therapy. This trial is being conducted at 36 centers nationwide and has randomized approximately 1495 patients.
NB-304 is a placebo-controlled, 56-week clinical trial designed to analyze the efficacy, safety and tolerability of Contrave in obese patients with Type II diabetes. Recent studies have demonstrated that obesity is a leading risk factor for diabetes, and this trial is designed to evaluate weight loss and factors related to glucose metabolism. This trial is taking place at 51 centers nationwide and has randomized approximately 500 patients.
“Completing enrollment for the entire Contrave Phase III program on schedule is a profoundly important milestone for the Company. Equally important has been the attention given to the quality execution of these studies by both the Orexigen team and our clinical investigators,” said Orexigen President and CEO, Gary Tollefson, MD, Ph.D. “Beyond the standard measures of efficacy, safety and tolerability, we have designed the Contrave Phase III clinical trials to address a number of the key secondary metabolic and behavioral endpoints that complicate are often associated with obesity.”
Orexigen previously announced completion of enrollment in its NB-301 trial in November 2007 and its NB-302 trial in April 2008. NB-301 is a placebo-controlled, 56-week clinical trial designed to analyze the efficacy, safety and tolerability of two doses of Contrave in generally healthy obese patients. NB-302 is a placebo-controlled, 56-week clinical trial designed to analyze the efficacy, safety and tolerability of Contrave when combined with an intensive behavior modification protocol.
Contrave is a proprietary fixed dose combination of bupropion sustained release (SR) and the Company’s novel formulation of naltrexone SR in a single tablet. Orexigen chose these two constituent drugs based on preclinical data that suggested that they act synergistically to initiate and sustain weight loss. Results from the first Phase III clinical trial are anticipated in late 2008 or early 2009.
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, including obesity. Orexigen’s lead combination product candidates targeted for obesity are Contrave®, which is in Phase III clinical trials, and Empatic™, which is in the later stages of Phase II clinical development. Both product candidates are designed to 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. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “intends,” “potential,” “suggests,” “assuming,” “designed,” “projects” and similar expressions are intended to identify forward-looking statements. These statements are based on the Company’s current beliefs and expectations. These forward-looking statements include statements regarding enrollment, timing, execution and completion of clinical trials of Contrave, the timing of an NDA submission with the FDA for Contrave, the efficacy and safety of Contrave, and the potential to obtain regulatory approval for, and effectively treat obesity with, Contrave. The inclusion of forward-looking statements should not be regarded as a representation by Orexigen that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risk and uncertainties inherent in the Company’s business, including, without limitation: the progress and timing of the Company’s Contrave clinical trials or the development of Contrave; the potential for adverse safety findings relating to Contrave to delay or prevent regulatory filings; 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 described in the Company’s filings with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Orexigen undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Contact:
Orexigen: Graham Cooper, 858-436-8600 or Media: BioCom Partners Stephen Gendel, 212-918-4650
Source: Orexigen Therapeutics, Inc.
