Long Acting Byetta Preliminary Results From Phase 2 Study Announced. As a once a week therapy, Byetta can be a blockbuster.”
Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. announced Tuesday the results from the ongoing Phase 2 multi-dose study of a long-acting release (LAR) formulation of BYETTA(TM) (exenatide) injection in patients with type 2 diabetes.
A1C, improved approximately 2 percent for subjects receiving the high dose of exenatide LAR, fasting blood glucose dropped 50mg/dl and average weight loss was 7 pounds compared to placebo.
The study was designed to assess the safety, tolerability and pharmacokinetics of exenatide LAR given once a week. After 15 weeks, both doses of exenatide LAR were well tolerated and expected therapeutic blood levels of exenatide were achieved. Dose-dependent improvements in hemoglobin A1C (A1C) and weight were observed.
A1C, a measure of glucose control, improved approximately 2 percent for subjects receiving the high dose of exenatide LAR, compared to placebo. At the beginning of the study, the average A1C of study participants was approximately 8.5 percent. The decrease in A1C was progressive with no evidence of a plateau at week 15. Twelve of the 14 high-dose subjects who entered the study with an A1C greater than 7 percent achieved an A1C of 7 percent or less at 15 weeks. None of the 14 subjects receiving placebo achieved that target.
Fasting blood glucose concentrations were reduced by approximately 50 mg/dL for subjects in the high dose group compared to those receiving placebo. Subjects in this group experienced an average weight reduction of approximately 9 pounds compared to those receiving placebo.
The most common adverse event was mild nausea, which occurred in approximately 20 percent of subjects in the high dose group compared to approximately 7 percent in the placebo group. No severe gastrointestinal side effects were reported. No severe hypoglycemia was reported, and no subjects receiving exenatide LAR withdrew because of adverse events.
This Phase 2, randomized, placebo-controlled, double-blind study includes 45 subjects with type 2 diabetes who were not achieving adequate glucose control using diet and exercise with or without metformin. Subjects were randomized to receive 15 once-weekly subcutaneous injections of exenatide LAR at one of two doses or placebo. At this time, study participants have completed the active dosing period. Subjects will be observed for an additional 12 weeks with follow-up observations and data analyses ongoing. The companies anticipate that the full study results will be presented in a future scientific forum.
On April 28, 2005, the Food and Drug Administration (FDA) approved twice daily exenatide under the trade name
YETTA(TM) (exenatide) injection for use by people with type 2 diabetes who are unsuccessful at controlling their blood sugar levels despite using commonly prescribed oral medications metformin, a sulfonylurea, or both. Amylin, Lilly, and Alkermes are working together to develop a sustained release, subcutaneous injection of exenatide for the treatment of type 2 diabetes based on Alkermes’ proprietary Medisorb(R) injectable long-acting release drug delivery technology. Exenatide LAR has not been approved by the FDA for marketing in the United States.
BYETTA is the first in a new class of drugs for the treatment of type 2 diabetes called incretin mimetics and exhibits many of the same effects as the human incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1, secreted in response to food intake, has multiple effects on the intestine, liver, pancreas and brain that work in concert to improve blood sugar (1).
About Incretin Mimetics: Incretin mimetics is a new class of treatment in the fight against diabetes. An incretin mimetic works to mimic the anti-diabetic or glucose-lowering actions of naturally occurring human hormones called incretins. These actions include stimulating the body’s ability to produce insulin in response to elevated levels of blood sugar, inhibiting the release of a hormone called glucagon following meals, slowing the rate at which nutrients are absorbed into the bloodstream and reducing food intake. BYETTA is the first FDA-approved agent of this new class of medications.
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