With its lead obesity drug poised to head to the FDA in search of an approval, Orexigen Therapeutics (OREX) pulled the covers off promising Phase IIb data on a follow-up drug that's now pointed to a late-stage trial.
The San Diego-based developer says that patients taking Empatic--a combination therapy that includes a well-known depression drug--hit the FDA's benchmarks for a successful obesity application. Patients completing 24 weeks of Empatic360 lost 9.9 percent of their baseline body weight, or 22 pounds, compared to 1.7 percent for placebo patients. There were no serious adverse events.
Orexigen is one of several developers pursuing late-stage trials of some of the most closely-watched obesity drugs in the clinic. As the company executives made clear this morning, obesity is a tough condition to treat. Patients are often forced to switch meds and there's a high need for multiple therapies. That significantly enhances the value of the obesity franchise Orexigen has been building.
The company is keeping a tight lid on partnering talks, but its CEO made it clear this morning that Orexigen is looking for a sizeable commitment as it continues to produce convincing trial data. "This is a strategic bet for Big Pharma to make," CEO Mike Narachi told analysts and reporters during a conference call this morning. Some pharma companies likely to be interested in Orexigen's programs are commercializing therapeutics that address ailments "downstream" from obesity--going upstream to a big unmet medical need like obesity "is not a bet taken lightly."