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Orexigen Therapeutics, Inc. (OREX) announced positive results today from a 24-week, Phase 2b trial for Empatic(TM)(bupropion SR/zonisamide SR), the Company's second late stage investigational combination drug for the treatment of obesity. The trial met its primary efficacy endpoint by demonstrating statistically significantly greater weight loss for both Empatic doses compared to monotherapies and placebo.
These data follow the announcement by the Company in July 2009 that Phase 3 trials evaluating Contrave(R) (bupropion SR/naltrexone SR), its lead investigational drug for the treatment of obesity, met their co-primary endpoints, exceeding the FDA categorical efficacy benchmark for clinically significant weight loss.
Mike Narachi, President and CEO of Orexigen, noted in a conference call today, "We are the only company with two late-stage product candidates for obesity."
He commented, "Empatic achieved its primary goal for the trial and produced significantly greater weight loss than any of its constituent parts. Patients who completed the trial at the higher dose achieved an average 9.9% weight loss after 24 weeks of therapy with a clear trajectory of continued loss beyond that point."
Dr. Eduardo Dunayevich, Chief Medical Officer of Orexigen, explained, "Both Empatic doses appear efficacious and could provide dosing flexibility. The vast majority of patients on both doses lost at least 5% of their body weight, and 48% of the patients lost at least 10% of body weight. Around 20% of patients lost at least 15% of their body weight. Furthermore, the average weight loss for these patients was in the range of 30-40 pounds. We also saw improvements in secondary biomarkers that included waist circumference, triglycerides, insulin levels and blood pressure."
Mr. Narachi concluded, "These results, along with Contrave(R), affirm the strength of our obesity franchise. They could complement each other and uniquely position us to cover a broad range of the obesity market. We also expect that partners will see a compelling opportunity to invest in an obesity franchise rather than a single product."
The Company plans to meet with the FDA for an End of Phase 2 meeting to discuss these data with the goal of defining a Phase 3 plan for Empatic. The Company remains on track to file a New Drug Application (NDA) for Contrave with the FDA in the first half of 2010.
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