Phase III Trials Underway of Axokine for Treatment of Obesity

Two Phase III studies have begun to test a new diet drug called Axokine for the treatment of obesity. The trials will study the long-term maintenance of weight loss after use of the drug but following shorter-term treatments than previously tested.

Axokine is a genetically re-engineered version of a human protein similar to leptin. Preclinical studies have shown that Axokine given by injection travels through the bloodstream to reach an area of the brain (hypothalamus) that regulates body weight. Researchers believe that Axokine activates a signal that suppresses appetite.

The randomized, double blind studies of 300 overweight or obese participants each will test the safety and effectiveness of Axokine compared with a placebo over two different time periods. Participants in the first study will be given Axokine or a placebo for 6 months and then will be followed for an additional 6 months after they stop taking the drug.

In the second study, participants will be given Axokine or a placebo for 3 months and the follow up will last for 9 months. The trials will both take place at the same time. At the end of the each study's follow up period, patients will be given Axokine or a placebo for a short period of re-treatment. Each study will run for a total of 18 months from enrollment to completion.

"Obesity is increasingly recognized as a significant global medical problem that requires new treatment options," said Dr. Louis Aronne, Clinical Associate Professor of Medicine at Cornell University Medical College and co-researcher of the studies. "I'm pleased by the progress of this unique new product candidate for obesity."

"In these new trials, we want to examine shorter term regimens which may be appropriate for patients who can reach their weight loss objectives over shorter time periods with our investigational candidate," said Dr. Leonard S. Schleifer, President of Regeneron, maker of Axokine. "These studies are designed to explore results we observed in Phase II, which showed that subjects taking Axokine for 3 months were able, on average, to maintain their weight loss during a 36-week evaluation period after treatment ended."

Other sources: Regeneron