Amylin and Takeda Suspend Obesity Study to Consider Metreleptin Data
The hits just keep coming for San Diego’s Amylin Pharmaceuticals (NASDAQ: AMLN), and not in a good way.
Amylin and Japanese strategic partner Takeda Pharmaceutical said today they have suspended a clinical trial examining the safety and effectiveness of an obesity drug candidate that combines pramlintide acetate, a synthetic analog of the natural hormone Amylin, with metreleptin, an analog of human leptin.
The companies formed a collaboration in November 2009 to co-develop the combination of pramlintide and metreleptin for obesity, in a deal with potential value to Amylin of more than $1 billion The partners say the study was voluntarily halted to investigate a new antibody-related laboratory finding with metreleptin treatment in two patients who participated in a previously completed clinical study of obesity.
Amylin notes that its decision does not affect another drug development program that is investigating the use of metreleptin to treat rare forms of lipodystrophy.
Earlier this month, Amylin, Lilly, and Alkermes suffered a setback in their development of exenatide once-weekly (Bydureon) for Type 2 diabetes, when they disclosed the treatment did not provide superior efficacy over an existing treatment.
The biggest shock came last October, when the FDA refused to approve exenatide once-weekly (Bydureon) for U.S. sale to diabetes patients. Regulators insisted that the company provide more data on the drug’s effect on heart rhythms.