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for the market. All the above companies point to other measurements of effectiveness, like their drugs’ ability to help reduce the risk of diabetes, high blood pressure, high cholesterol, and depression—all ailments related to obesity.
Amylin’s game plan is unlike other companies, which are developing small-molecule drugs, taken as oral pills, that hit receptors on brain cells that control whether people feel full. The problem with those medicines is that they tend to hit other cells in the brain that control moods, leading to side effects, Weyer has said.
The Amylin approach is to use pramlintide, a genetically modified version of a hormone that’s secreted from the pancreas to slow down stomach emptying. It’s combined with metreleptin, a genetically modified version of the leptin hormone that’s secreted from fat cells, which sends a signal to the brain that it’s time to stop eating, Weyer says. The company’s scientists believe the drugs have complementary action, which is greater than either individual part, Weyer says. Since they are relatively large molecules, they are too big to cross the blood-brain barrier, and shouldn’t cause mood-altering side effects, he says.
What are the next steps for Amylin? Weyer wasn’t ready to make many announcements when we talked. The company wants to see the full one-year results which should come out by the end of 2009 and get presented at a major medical meeting in 2010. It will need to carefully look over the data from the Phase II trial to determine the Phase III clinical trial design, which will go a long way toward finding a market niche for the Amylin drug combo.
Amylin is currently working on a device that would allow pramlintide and metreleptin to be given in a single shot, instead of in two shots a day, although Weyer said it’s too early to comment on how that might be incorporated into Amylin’s development plans. But he made it sound like the drug will be positioned in the market as the big gun for weight loss, and won’t try to hang its hat entirely on some secondary measurements of effectiveness.