Exenatide Continues to Generate Positive Results in Second of Three Phase 3 Studies
November 10 2003 - 4:15PM
PR Newswire (US)
Exenatide Continues to Generate Positive Results in Second of Three
Phase 3 Studies SAN DIEGO, and INDIANAPOLIS, Nov. 10
/PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc., and Eli
Lilly and Company today announced that exenatide (synthetic
exendin-4) produced statistically significant, dose-dependent
reductions in the glucose control endpoint in a seven-month Phase 3
pivotal study in people with type 2 diabetes failing to achieve
target blood glucose levels with sulfonylurea alone. Reductions in
average blood glucose were similar to reductions observed in the
first exenatide pivotal study announced in August 2003. At the end
of the study, 41 percent of subjects completing the study on the
highest dose of exenatide (10 micrograms twice daily) reduced their
hemoglobin A1c (A1C) levels to less than or equal to 7 percent. A1C
is a measure that reflects average glucose levels over the prior 3
to 4 month period. The subjects receiving the highest dose of
exenatide also showed statistically significant reductions in body
weight. This is the second of three pivotal phase 3 studies of
exenatide, the first in a new class of compounds known as incretin
mimetics, which is being developed as a potential treatment for
type 2 diabetes. Results from these three studies will form the
basis of a planned submission to the Food and Drug Administration
(FDA), currently anticipated in mid-2004. The companies are on
track to report the results from the remaining pivotal trial before
the end of the year. Exenatide is being investigated for its
potential to address important unmet medical needs of many people
with type 2 diabetes. Clinical trials suggest that exenatide
treatment decreases blood glucose toward target levels and is
associated with weight loss. The effects on glucose control seen
with exenatide treatment are likely due to several actions that are
similar to those of the naturally occurring incretin hormone
glucagon-like peptide-1 (GLP-1). These actions include stimulating
the body's ability to produce insulin in response to elevated
levels of blood glucose, inhibiting the release of glucagon
following meals and slowing the rate at which nutrients are
absorbed into the bloodstream.(1) In animal studies exenatide
administration resulted in preservation and formation of new beta
cells,(2) the insulin-producing cells in the pancreas, which fail
as type 2 diabetes progresses. Key Study Details Of the 377
randomized subjects, approximately two-thirds received exenatide
and one-third received placebo. Those on active drug received an
introductory 5-microgram dose of exenatide for one month, given by
subcutaneous injection twice a day at breakfast and dinner. This
was followed by six months of exposure to doses of either 5
micrograms or 10 micrograms given twice a day at breakfast and
dinner. Overall, no severe hypoglycemia was observed. As glucose
control improved in the exenatide arms of the study, the rate of
mild to moderate, sulfonylurea-induced hypoglycemia increased.
Patients in the study were instructed to maintain their maximally
effective dose of sulfonylurea unless hypoglycemia occurred, at
which point they were instructed to reduce their dose of
sulfonylurea. Patients treated with the highest dose of exenatide
showed the greatest improvement in A1C and a 36% incidence of mild
to moderate hypoglycemia. In contrast, the placebo arm, with no
improvement in A1C, had an incidence of hypoglycemia of 3%. Only
one subject receiving exenatide withdrew from the study due to mild
to moderate hypoglycemia. Although nausea was the most frequent
adverse event, it was transient in nature and only eight patients
receiving exenatide discontinued as a result. Antibody formation
observed in this study is consistent with previous exenatide data
reported to date. The data do not demonstrate a relationship
between antibody formation and exenatide's sustained effect on A1C.
Diabetes -- The Need for New Treatments Diabetes affects an
estimated 194 million adults worldwide(3) and more than 17 million
in the United States.(4) Approximately 90-95 percent of those
affected have type 2 diabetes, in which either the body does not
produce enough insulin or the cells in the body do not respond
normally to the insulin. According to the US Center for Disease
Control's National Health and Examination Survey, 57 percent of
diabetes patients do not achieve target A1C levels with their
current treatment regimen and approximately 41 percent have A1Cs
above 8 percent. According to the ADA, patients with A1Cs above
target are more likely to develop diabetes-related complications,
such as kidney disease, blindness and heart disease.(5) About
Amylin and Lilly Amylin Pharmaceuticals is committed to improving
the lives of people with diabetes and other metabolic disorders
through the discovery, development and commercialization of
innovative, cost-effective medicines. Further information on Amylin
Pharmaceuticals and its pipeline in metabolism is available at
http://www.amylin.com/. Lilly, a leading innovation-driven
corporation is developing a growing portfolio of best-in-class
pharmaceutical products by applying the latest research from its
own worldwide laboratories and from collaborations with eminent
scientific organizations. Headquartered in Indianapolis, Ind.,
Lilly provides answers -- through medicines and information -- for
some of the world's most urgent medical needs. Additional
information about Lilly is available at http://www.lilly.com/. This
press release contains forward-looking statements, which involve
risks and uncertainties. Actual results could differ materially
from those forward-looking statements discussed in this press
release. There can be no assurance that current or future clinical
trials will confirm the preliminary results referred to in this
release, that a new drug application will be filed for exenatide on
a timely basis, or that exenatide will receive regulatory approvals
or prove to be commercially successful. Additional risks and
uncertainties are described more fully in both Lilly's and Amylin's
most recently filed SEC documents, such as their Annual Reports on
Form 10-K for the fiscal year ended December 31, 2002 under the
heading "Risk Factors," and their Quarterly Reports on Form 10-Q.
(1) Kolterman, O, Buse J, Fineman M, Gaines E, Heintz S, Bicsak T,
Taylor K, Kim D, Aisporna M, Wang Y, Baron A. Synthetic exendin-4
(exenatide) significantly reduces postprandial and fasting glucose
in subjects with type 2 diabetes. Journal of Clinical Endocrinology
& Metabolism 2003; 88(7):3082-3089 (2) Xu G, Stoffers DA,
Habener JF, Bonner-Weir S. Exendin-4 stimulates both b-cell
replication and neogenesis, resulting in increased b-cell mass and
improved glucose tolerance in diabetic rats. Diabetes 1999;
48:2270-2276 (3) The International Diabetes Federation Diabetes
Atlas. Available at:
http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-
87B73F80BC22682A. Accessed August 6, 2003. (4) American Diabetes
Association. Available at:
http://www.diabetes.org/main/info/facts/facts_natl.jsp. Accessed
August 6, 2003. (5) Saaddine JB, Engelgau MM, Beckles GL, Gregg EW,
Thompson TJ, Narayan KM. A diabetes report card for the United
States: Quality of care in the 1990s. Ann Intern Med. 2002;
136:565-574. DATASOURCE: Amylin Pharmaceuticals, Inc.; Eli Lilly
and Company CONTACT: Eric Shearin of Amylin Pharmaceuticals, Inc.,
+1-858-552-2200; or Morry Smulevitz of Eli Lilly and Company,
+1-317-651-5567 Web site: http://www.amylin.com/
http://www.lilly.com/
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