|Amylin, Eli Lilly And Alkermes Announces Phase 2 Study Results|
|By Staff and Wire Reports|
|Friday, 24 June 2011 19:45|
Amylin Pharmaceuticals, Inc., (NASDAQ:AMLN), Eli Lilly and Company (NYSE:LLY) and Alkermes, Inc. (NASDAQ:ALKS) announced additional results from a Phase 2 study of an investigational, once-monthly injectable suspension formulation of exenatide which showed substantial improvements in glycemic control, including reductions in A1C and fasting plasma glucose, with modest weight loss.
The 121-patient study assessed the efficacy, safety and tolerability of three different doses (5 mg, 8 mg and 11 mg) of exenatide once monthly, a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist.
After a total of five injections (20 weeks of treatment), patients receiving exenatide once a month, experienced average improvements in A1C from baseline of 1.3% points for the 5 mg and 8 mg doses and 1.5% points for the 11 mg dose. 50% of those treated with the 5 mg dose, 57% treated with the 8 mg dose and 70% treated with the 11 mg dose achieved an A1C of less than 7%, the ADA-recommended target for good glucose control.
Although some patients lost some weight, exenatide once monthly, is not being studied as a weight-loss product. Fasting plasma glucose was improved with all doses, with reductions of 25 mg/dL with the 5 mg dose, 30 mg/dL with the 8 mg dose and 49 mg/dL with the 11 mg dose.
The mean pharmacokinetic profile showed all three exenatide once monthly doses resulted in steady-state exenatide plasma levels within the known therapeutic range.
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