Statistical Significance Achieved for Primary Endpoint in Phase 3 Study
SAN DIEGO, Aug. 31 /PRNewswire/ -- Amylin Pharmaceuticals, Inc.
(Nasdaq: AMLN) today announced that its lead diabetes drug candidate,
SYMLIN(TM) (pramlintide acetate), produced a statistically significant
lowering of the primary glucose control endpoint in a one-year study in people
with type 2 diabetes who use insulin. Additionally, study participants who
received SYMLIN experienced a statistically significant reduction in body
weight.
In the intent-to-treat analysis, patients receiving SYMLIN in addition to
their usual diabetes therapy achieved a statistically significant improvement
in glycated hemoglobin (HbA1c) at 6 months, compared to those in the control
group, who received their usual diabetes therapy alone. Those receiving a
dosage of 120 micrograms twice daily (BID) achieved a reduction of 0.7% in the
primary endpoint of HbA1c at 6 months, compared to a reduction of 0.3% in the
control group (p=0.003). For patients in the SYMLIN 120 microgram BID group
who completed one year of treatment, the reduction in HbA1c was 0.7%, compared
with a reduction of 0.1% for the control group (p=0.001). The lower dosage
group, SYMLIN 90 micrograms BID, did not reach statistical significance for
the primary endpoint (p=0.057). Overall, the observations in the SYMLIN
120 and 90 microgram BID groups are consistent with previously reported study
results.
SYMLIN is an investigational new drug in Phase 3 development for use in
type 1 and insulin-using type 2 diabetes. The Company has not submitted
applications for regulatory review, and regulatory authorities have not yet
made a determination as to the safety or efficacy of SYMLIN.
Study Design
People with type 2 diabetes whose usual diabetes treatment regimens
comprised insulin with or without oral hypoglycemic agents were enrolled in
over 75 research centers in the US. At least 90% of those enrolled in the
study were using multiple injections of insulin each day. Participants
continued their usual diabetes treatment regimens and were randomized to
receive SYMLIN 120 micrograms BID, SYMLIN 90 micrograms BID, or placebo.
HbA1c, an accepted clinical standard, was measured to assess glucose control
during the one-year study. The primary endpoint was change in HbA1c from
baseline to 6 months for the SYMLIN groups compared with the control group. A
predefined secondary endpoint was HbA1c change from baseline in study
participants who were identified as glycemic "responders" by having achieved
at least a 0.5% HbA1c reduction four weeks after the initiation of study drug.
Additional Study Results
-- Participants receiving SYMLIN 120 micrograms BID lost 3.1 pounds at
the end of one year, while those in the control group gained 1.5
pounds (p=0.001).
-- In the SYMLIN 120 microgram BID group, 44% of participants were
identified as glycemic "responders." As observed in previous studies,
this "responder" rate was approximately twice that of the control
group. Glycemic "responders" in the SYMLIN 120 microgram BID group
had an average reduction in HbA1c of at least 1.0% from Week 13
through the end of the one-year study.
-- No safety issues of concern were identified during the study, and the
data indicated that all dosages were well tolerated. There was no
difference in the annual event rate for severe hypoglycemia between
the SYMLIN and control groups.
"I am pleased to see these results, which show a statistically significant
improvement in HbA1c. Patients with type 2 diabetes using multiple insulin
injections each day have limited therapeutic options, and additional therapies
are much needed," noted Robert E. Ratner, MD, MedStar Research Institute,
Washington DC. "Data from the recently completed United Kingdom Prospective
Diabetes Study (UKPDS) demonstrated that, in people with type 2 diabetes,
reducing glucose reduces the risk of diabetic complications. Additionally,
patients in the UKPDS noted weight gain in association with improved glycemic
control."
Type 2, or adult onset, diabetes is a progressive disorder. Approximately
19 million people in North America and Western Europe have been diagnosed with
type 2 diabetes. Initially able to manage their diabetes with diet, exercise,
and/or oral diabetes medications, over time many people need injections of
insulin each day to enable their bodies to metabolize and store food. Amylin
estimates that approximately 3.3 million people with type 2 diabetes in North
America and Western Europe use multiple insulin injections each day. These
people, who have limited available therapeutic options, are the focus of the
SYMLIN clinical development program for type 2 diabetes.
"People with type 2 diabetes who use multiple injections of insulin each
day frequently experience persistent weight gain, in spite of the use of
combination therapies. Concern about weight gain often limits their ability
to achieve and maintain their glycemic targets," said Matthew C. Riddle, MD,
Oregon Health Science University, Portland. "A new therapy that could help
these people move toward their glucose goals without gaining weight would be a
welcome addition to their treatment regimens."
Type 1 Study On Schedule
The Company's ongoing one-year, Phase 3, US study of SYMLIN in type 1
diabetes is on schedule. Results are planned to be reported in the fourth
quarter of this year.
"We are excited to learn that the SYMLIN 120 microgram BID group achieved
the primary endpoint in this US study," said Joseph C. Cook, Jr., Chairman and
Chief Executive Officer at Amylin Pharmaceuticals. "With these results in
insulin-using type 2 diabetes, and if we achieve favorable results in the
ongoing type 1 diabetes study, the Company intends to submit applications to
appropriate regulatory authorities in North America and Europe in mid-2000."
Amylin Pharmaceuticals, Inc. is a development pharmaceutical company
focused on metabolic disorders, and specializing in preclinical
characterization of lead molecules and demonstration of proof of principle in
humans. The Company has pioneered research of the hormone amylin and is
developing SYMLIN(TM) (pramlintide acetate), a synthetic analog of human
amylin, for the treatment of diabetes in people using insulin. AC2993
(synthetic exendin-4), the Company's second diabetes drug candidate, is being
evaluated in type 2 diabetes and related metabolic disorders. The Company has
successfully completed a Phase 1 safety and tolerability trial and a clinical
study of AC2993 in people with type 2 diabetes. A Phase 2, multiple-dose
study in people with type 2 diabetes is currently in progress and results are
planned to be reported in the fourth quarter of 1999. The Company has
demonstrated that AC2993 is biologically active in animal models when
administered via noninjectable routes. The Company is currently engaged in
partnership discussions for SYMLIN and AC2993. Amylin Pharmaceuticals is
headquartered in San Diego, California. Further information on the Company
and its development pipeline is available at amylin.com. |
