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Orexigen is the only company with two late-stage product candidates to address a broad spectrum of obesity patients
SAN DIEGO, CA USA | July 9, 2008 | Orexigen(R) Therapeutics, Inc. (Nasdaq: OREX) announced today that it has begun randomizing patients in ZB-202, a second Phase IIb clinical trial for Empatic(TM), one of the Company's two late-stage obesity product candidates. The trial is designed to build on highly encouraging safety and efficacy results from a previous Phase IIb trial of Empatic, which demonstrated robust weight loss at 48 weeks ranging from approximately 11 percent to 15 percent in obese patients completing the trial and a discontinuation rate due to adverse events that was not significantly different than placebo.
"Initiation of ZB-202 is an important milestone for our Empatic program and the final anticipated step before moving into Phase III development," said Gary Tollefson, M.D., Ph.D., Orexigen President and CEO. "Empatic continues to be an important component of the Company's obesity program. Along with Contrave(R), now in Phase III clinical trials, these product candidates both have the potential to target a large, distinct and complementary segment within the obesity market."
Orexigen is the only company currently developing two late-stage product candidates to address the full spectrum of obesity ranging from mild-to-moderate and moderate-to-severe obesity. Obesity has become a national epidemic, with more than 70 million Americans classified as obese and 300,000 deaths a year attributable to obesity, according to the Centers for Disease Control (CDC). Obesity is associated with a number of significant medical conditions, including diabetes, hypertension, high cholesterol and coronary artery disease, among others. Research has shown that obesity has a greater impact on the development of chronic conditions in the U.S. than poverty, nicotine or alcohol abuse. Obesity also places a significant financial burden on the economy with mortality and morbidity costs estimated to exceed $100 billion annually.
Empatic combines zonisamide and bupropion, two existing drugs that have been independently approved by the U.S. Food and Drug Administration (FDA) to treat other central nervous system disorders. Orexigen has developed a proprietary sustained release (SR) formulation of zonisamide that has demonstrated a better tolerability profile than the legacy, immediate release (IR) formulation. These two drugs were selected based on their complementary activity in reducing appetite, increasing the body's burning of calories and sustaining weight loss.
The Company's other late-stage obesity product candidate, Contrave(R), is a combination of bupropion SR and naltrexone in a proprietary SR formulation that also appears to result in improved tolerability compared to the legacy naltrexone IR formulation. Contrave currently is being studied in four Phase III clinical trials that are fully enrolled. The program continues on schedule with initial results anticipated in late 2008 or early 2009 and the filing of a New Drug Application (NDA) with the FDA projected for late 2009.
Phase IIb Empatic Trial Details
ZB-202 is a randomized, double-blind, placebo-controlled trial involving approximately 720 generally healthy, nondiabetic obese patients at 20 sites nationwide. The primary endpoint for this trial is percent change in body weight after 24 weeks of blinded therapy. Patients will be randomized to one of six treatment groups including two of the Empatic doses associated with weight loss in the previous Phase IIb trial. The efficacy of Empatic will be compared against zonisamide monotherapy, bupropion monotherapy and placebo. Trial results are expected in the second half of 2009.
About Orexigen Therapeutics
Orexigen(R) Therapeutics, Inc. is a biopharmaceutical company focused on the development of pharmaceutical product candidates for the treatment of central nervous system disorders, including obesity. The Company's late-stage product candidates targeting obesity are Contrave(R), which is in Phase III clinical trials, and Empatic(TM), which is in Phase IIb clinical development. Orexigen is developing other proprietary drugs for use in other central nervous system disorders. Further information about the Company and its pipeline can be found at http://www.Orexigen.com.
SOURCE Orexigen Therapeutics, Inc. |
