Amylin and partner Takeda suspended a Phase II trial of their obesity drug, a combination of diabetes drug pramlintide and analogue hormone metreleptin. The study was halted so that the companies could investigate a new antibody-related laboratory with metreleptin treatment in two patients who participated in a previously completed clinical study of obesity.
"The safety of patients in our clinical programs is of paramount concern to the companies. We have taken this precaution so that we can thoroughly investigate this finding," said Orville Kolterman, M.D., senior vice president and chief medical officer of Amylin Pharmaceuticals. Amylin stressed that the halt won't have any impact on the company's lipodystrophy development program investigating the use of metreleptin to treat diabetes and/or hypertriglyceridemia in patients with rare forms of lipodystrophy.
The announcement is one more piece of bad news for the already beleaguered field of obesity drug development. In the past year the FDA has shot down potential treatments from Orexigen, Vivus and Arena Pharmaceuticals. Safety remains the biggest stumbling block for developers in the field.
- check out the release
- here's more from the Wall Street Journal
Special Report: Obesity drugs: Where are we now?