Clinical proof-of-concept study will also evaluate whether metreleptin can reduce the amount of insulin needed by patients with type 1 diabetes

NEW YORK and SAN DIEGO, Nov. 16, 2010 /PRNewswire-USNewswire/ -- The Juvenile Diabetes Research Foundation (JDRF) and Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) announced today that they entered into a research collaboration agreement to provide financial support for a clinical proof-of-concept study to investigate the effects of metreleptin, an analog of the human hormone leptin, in patients with type 1 diabetes. Researchers at The University of Texas (UT) Southwestern Medical Center will conduct the study.

Prior studies at UT Southwestern conducted in animal models with type 1 diabetes showed an improvement in blood glucose, blood fats, and cholesterol following administration of the hormone. The clinical study will help to determine if similar improvements in glucose, and reduction of the amount of insulin required, can be achieved in people with type 1 diabetes. Leptin is a hormone secreted by fat cells that plays a fundamental role in the regulation of glucose metabolism.

"Better blood glucose control means healthier living for people with type 1 diabetes," said Aaron Kowalski, Ph.D., Assistant Vice President of Treatment Therapies at JDRF. "If effective in humans, metreleptin, when used with insulin, could change the way people manage their disease. Less insulin usage and fewer low blood sugar episodes would represent a significant improvement in quality of life for certain people living with type 1 diabetes today."

"Building on our development experience with type 1 diabetes, we continually look for ways to unleash the potential of peptide and protein science to help the millions of patients with diabetes better manage their disease," said David Maggs, MD, MRCP, Vice President for R&D Strategic Relations at Amylin. "We are pleased to partner on this important research program with an organization that shares our passion for investigating the potential promise of new and innovative therapies."

The research collaboration agreement between JDRF and Amylin is part of JDRF's Industry Discovery and Development Partnership (IDDP) program through which JDRF partners with pharmaceutical, biotechnology, and medical device companies focused on the discovery, development, and delivery of therapeutics and devices for type 1 diabetes and its complications. Since the IDDP program was established in 2004, JDRF has funded 35 partnerships with 29 companies and committed approximately $71 million to accelerate research that will lead to better treatments and a cure for type 1 diabetes.

About the Study

This proof-of-concept clinical study will investigate whether treatment with metreleptin can help improve blood sugar control and decrease the daily doses of insulin required in patients with type 1 diabetes. This is the first clinical study evaluating metreleptin treatment in patients with type 1 diabetes. The study will also evaluate whether treatment with metreleptin can improve variability in blood sugar levels, including the propensity for hypoglycemia (low blood sugar levels), which affects many people with type 1 diabetes.

Conducted by researchers at UT Southwestern in Dallas, Texas, including Roger Unger, MD, professor of internal medicine, the study will enroll 12 to 15 patients with type 1 diabetes. Patients will add metreleptin twice a day to their usual insulin therapy over a five-month period. The insulin dosage will gradually be reduced to further characterize the effect of metreleptin on overall blood glucose. This study will build on recent preclinical findings by Dr. Unger and his team that showed leptin administration improved blood glucose levels, blood fats, and cholesterol in animal models of type 1 diabetes.

Abhimanyu Garg, MD and Greg Clark, MD will conduct the clinical arm of the project. Additional information about UT Southwestern can be found at www.utsouthwestern.edu.

"We were highly encouraged by the results of our study of leptin in animal models and look forward to learning whether using metreleptin with insulin yields similar results in humans," said Dr. Unger. "Achieving a substantial reduction in insulin doses and lowering the risk of low blood glucose levels could enhance the quality of life for people with type 1 diabetes."  

About Leptin

Leptin, a fat cell hormone that plays a key role in regulating metabolism, was first discovered in 1994 by Dr. Jeffrey Friedman of The Rockefeller University in New York. Dr. Friedman has won numerous awards during his career and recently won the 2010 Lasker Award in basic medical research for his work. Metreleptin, an analog of human leptin, has been studied as a potential treatment for obesity, type 2 diabetes, and severe lipodystrophy.

About JDRF

JDRF is a leader in setting the agenda for diabetes research worldwide, and is the largest charitable funder of and advocate for type 1 diabetes research. The mission of JDRF is to find a cure for diabetes and its complications through the support of research. Type 1 diabetes is an autoimmune disease that strikes children and adults suddenly, and can be fatal. Until a cure is found, people with type 1 diabetes have to test their blood sugar and give themselves insulin injections multiple times or use a pump - each day, every day of their lives. And even with that intensive care, insulin is not a cure for diabetes, nor does it prevent its potential complications, which may include kidney failure, blindness, heart disease, stroke, and amputation. To help improve the lives of people with type 1 diabetes while working toward a cure, one of JDRF's research goals is to support research to develop products that can dramatically improve blood glucose control in people with type 1 diabetes so they can live healthier lives with less risk of developing disease-related complications.  

Since its founding in 1970 by parents of children with type 1 diabetes, JDRF has awarded more than $1.5 billion to diabetes research, including more than $107 million last year. More than 80 percent of JDRF's expenditures directly support research and research-related education. For more information, please visit www.jdrf.org.

About Amylin Pharmaceuticals, Inc.

Amylin Pharmaceuticals is a biopharmaceutical company dedicated to improving lives of patients through the discovery, development and commercialization of innovative medicines. Amylin has developed and gained approval for two first-in-class medicines for diabetes, SYMLIN®(pramlintide acetate) injection and BYETTA® (exenatide) injection. Amylin's research and development activities leverage the Company's expertise in metabolism to develop potential therapies to treat diabetes and obesity. Amylin is headquartered in San Diego, Calif. Further information on Amylin Pharmaceuticals is available at http://www.amylin.com.

This press release contains forward-looking statements about Amylin, which involve risks and uncertainties. Amylin's actual results could differ materially from those discussed herein due to a number of risks and uncertainties, including that clinical trials or studies, including the metreleptin clinical study mentioned in this press release, may not start when planned, confirm previous results, be predictive of real world use, or achieve intended clinical endpoints; preclinical studies, including the preclinical study mentioned in this press release, may not be predictive; our product candidates may not receive regulatory approval; and inherent scientific, regulatory and other risks in the drug development and commercialization process; SYMLIN and the SymlinPen, and the revenues generated from these products, may be affected by competition, unexpected new data, technical or safety issues, or manufacturing and supply issues. Commercial and government reimbursement and pricing decisions and the pace of market acceptance may also affect the potential for SYMLIN and the SymlinPen®. These and additional risks and uncertainties are described more fully in Amylin's most recently filed SEC documents, including its Form 10-Q. Amylin undertakes no duty to update these forward-looking statements.

SOURCE Juvenile Diabetes Research Foundation