Intranasal Exenatide for Type II Diabetes

Description:

Exenatide, also referred to as exendin-4, is a 39 amino acid peptide that stimulates insulin secretion in response to elevated plasma glucose levels. It has been demonstrated in human clinical trials that exenatide has the ability to address the symptoms often found with patients diagnosed with type II diabetes by slowing the emptying of the stomach, inhibiting production of glucose by the liver and, in addition, appears to suppress the appetite. Exenatide is the active ingredient in the currently marketed product BYETTA^®, as a twice daily injection. BYETTA^® is indicated as an adjunct therapy to improve glycemic control in patients with type II diabetes who are taking metformin, a sulfonylurea, or a combination therapy but have not achieved adequate glycemic control. Exenatide cannot be effectively administered orally, thus creating an opportunity for an intranasal delivery route as an alternative to multiple daily injections.

Development Status:

Phase I

Partnership Status:

Partnered with Amylin Pharmaceuticals, Inc. to develop an intranasal version of exenatide

Intranasal Insulin for Type I Diabetes

Description:

Insulin is a necessary hormone, made by beta cells within the pancreas. Beta cells release insulin in response to the body’s detection of increased blood sugar levels after food intake. In type I diabetes, the body is incapable of producing insulin. Therefore, cells in the patient’s body are unable to appropriately process glucose (sugar) from the blood stream. A wide variety of insulin products are marketed to treat type I diabetes. Typically these products must be injected multiple times per day. Insulin cannot be delivered orally, thus creating the opportunity to replace multiple daily injections with a nasal spray administration.

Development Status:

Nastech reported positive results from a Phase I pharmacokinetic study. This study was designed to evaluate and compare the safety, bioavailability and the glucose response of Nastech’s proprietary intranasal insulin formulation with approved insulin products delivered by injection and inhalation. The pharmacokinetic-pharmacodynamic relationship of the cross-over Phase I study demonstrated a high correlation between either Cmax or AUClast and the maximum glucose response. Dr. Harold E. Lebovitz, Professor of Medicine in the Division of Endocrinology at the State University of New York (SUNY) Health Science Center at Brooklyn states, “the rapid absorption of a nasal product may have a unique value proposition compared with other insulin formulations on the market, especially in type 2 patients who have adequate insulin stores but a slow post-meal insulin response.” Based on the potential of insulin nasal spray to become a safe and effective non-invasive therapy, Nastech will conduct additional formulation work to increase both bioavailability and the duration of effect.

Partnership Status:

Available for Partnering

Clinical Need:

Diabetes is a group of diseases marked by high levels of blood glucose. This results from defects in insulin production, insulin sensitivity, or both. According to the Centers for Disease Control and Prevention, National Institutes of Health and American Diabetes Association, an estimated 20.8 million people in the United States (7% of the population) have diabetes with 1.5 million new people diagnosed every year. Type II diabetes accounts for an estimated 90 to 95 percent of all cases. Diabetes can lead to premature death and serious complications including; heart disease and stroke, high blood pressure, kidney disease, blindness and nervous system disease, to name a few. The total direct and indirect costs resulting from diabetes reached $132 billion in 2002.

Recent News:

06 December 2006: Nastech Announces Positive Phase 1 Clinical Results of Insulin Nasal Spray Compared to Exubera® Inhalation Powder and NovoLog© Insulin Aspart Injection

26 June 2006: Nastech Pharmaceutical Company Inc. Enters into Development and License Agreement with Amylin Pharmaceutical, Inc.

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External Links:

American Diabetes Association
The Endocrine Society
National Center for Chronic Disease Prevention and Health Promotion