To All... News,
Amylin Pharmaceuticals Begins First Human Study of Exendin-4, Its Second Diabetes Drug Candidate
PR Newswire, Tuesday, August 18, 1998 at 07:51
SAN DIEGO, Aug. 18 /PRNewswire/ -- Amylin Pharmaceuticals, Inc.
(NASDAQ:AMLN) today announced that it has initiated a Phase 1 clinical study
of AC2993 (exendin-4), an investigational drug for type 2 diabetes. Exendin-4
was originally isolated from the salivary secretions of the Gila monster, a
lizard that is native to the Arizona deserts. Now, a synthetic version of
this peptide is being administered subcutaneously to normal human volunteers.
This single-dose-escalation study, which is taking place in the United
Kingdom, is designed to test the safety and tolerability of exendin-4. Based
on the results of this Phase 1 clinical trial, concept testing studies in
patients with type 2 diabetes could begin in 1999.
"In late 1996, we acquired exclusive patent rights to two exendin
molecules from their discoverer, John Eng, M.D. of Bronx, New York, and have
expeditiously moved exendin-4 through research into early human testing," said
Maurizio Denaro, M.D., Amylin Pharmaceuticals' Executive Vice President and
Chief Technical Officer. "Over 50% of the structure of exendin-4 is
homologous to glucagon-like peptide-1 (GLP-1), a human hormone thought to be
important in glucose metabolism. However, exendin-4 is pharmaceutically more
attractive than GLP-1, one reason being its longer duration of biological
action. Data that we have obtained so far from animal models supports the
idea that exendin-4 may be a promising drug candidate for treating type 2
diabetes and related metabolic disorders such as obesity."
Exendin-4 has been shown to exert effects that appear important for
metabolic and glucose control. In animal models, exendin-4 stimulated
secretion of insulin (a glucose-lowering hormone) in the presence of excess
blood-glucose concentrations and not during periods of hypoglycemia -_
dangerously low blood-glucose concentrations. Exendin-4 also modulated
gastric emptying to slow the entry of ingested nutrients into the bloodstream.
Chronic subcutaneous administration of exendin-4 lessened food consumption in
obese animals, leading to reduced body weight. Most importantly,
administration of exendin-4 has resulted in near normalization of glucose
control in animal models of type 2 diabetes.
Type 2 diabetes is a complex disease typically characterized by elevated
blood-glucose concentrations, insulin resistance and obesity. As the disease
progresses, treatment often becomes ineffective and must be supplemented or
replaced with insulin. The Company believes that exendin-4 has the potential
to be of therapeutic value across a wide scope of this disease. Currently, it
is estimated that 15 million people in the United States suffer from type 2
diabetes.
"Initiation of this modest-cost Phase 1 study of exendin-4 is part of the
Company's directed strategy to broaden its metabolic drug development
activities beyond pramlintide," said Joseph C. Cook, Jr., Amylin's Chairman
and Chief Executive Officer. "Pramlintide, a synthetic analogue of human
amylin that was invented and patented by the Company, is the subject of four
ongoing Phase 3 clinical trials. We expect to report results from two of
these studies in the fourth quarter of this year. We are currently in
discussions with potential corporate partners who might aid in the development
and commercialization of pramlintide and/or exendin-4."
Amylin Pharmaceuticals, Inc. is focused on developing novel medicines for
treating metabolic disorders. The Company has pioneered research of the
hormone amylin, which is believed to play an important role in metabolic
control and is missing or deficient in millions of people with diabetes. The
Company is developing pramlintide, its patented synthetic analog of human
amylin, for the treatment of diabetes. Four, ongoing Phase 3 clinical studies
of pramlintide are fully enrolled. The studies, two each in type 1 and
insulin-using type 2 diabetes, are designed to test pramlintide's safety and
efficacy and thereby support regulatory filings in Europe and the United
States. AC2993 (exendin-4), an investigational drug for type 2 diabetes and
related metabolic disorders, is currently undergoing Phase 1 safety and
tolerability testing. The Company has a research and development pipeline
within the field of metabolic disorders, including preclinical programs for
GLP-1 for type 2 diabetes and obesity, lipid-lowering antioxidants for
atherosclerosis and prevention of restenosis, and new drug targets for
obesity, including mitochondrial uncoupling proteins. Amylin Pharmaceuticals
is headquartered in San Diego, California and has European operations
headquartered in Oxford, U.K.
This press release contains forward-looking statements that involve risks
and uncertainties. The Company's actual results could differ materially from
those discussed herein, due to risks and uncertainties regarding, among other
things, the drug discovery and development process, the results of the
Company's ongoing and planned clinical studies of pramlintide and AC2993
(exendin-4), the Company's ability to raise additional capital to finance its
business operations, the timing of filing for regulatory approval of
pramlintide, and if such approval is received, time to market thereafter.
Additional risks and uncertainties are described in the Company's most
recently filed SEC documents, such as its Form 10-K and 10-Q.
SOURCE Amylin Pharmaceuticals, Inc.
-0- 08/18/98
/CONTACT: Richard W. Krawiec, Ph.D., Director of Corporate Communications
of Amylin Pharmaceuticals, Inc., 619-552-2200/
/Company News On-Call: prnewswire.com or fax, 800-758-5804,
ext. 100201/
/Web site: amylin.com
Companies or Securities discussed in this article:
Symbol Name
NASDAQ:AMLN Amylin Pharmaceuticals Inc
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