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October 4, 2007
Aegerion Pharmaceuticals, Inc. Presents Final Results of Phase II
Clinical Trials for AEGR-733 at Drugs Affecting Lipid
Metabolism (DALM) 2007 Conference
Lead Compound Produces Significant LDL-Cholesterol Reduction
and Weight Loss When Combined with ZetiaŽ in
Hypercholesterolemic Patients
BRIDGEWATER, NJ (October 4, 2007) — Aegerion
Pharmaceuticals, Inc., a specialty pharmaceutical company
focused on the treatment of cardiovascular and metabolic
diseases, today announced final results of Phase II clinical
trials involving its lead cholesterol management compound,
an MTP-inhibitor, AEGR-733 either alone or in combination
with ezetimibe (brand name: ZetiaŽ*).The data were presented
in two posters at the Drugs Affecting Lipid Metabolism
(DALM) 2007 conference (October 4-7, 2007, New York, NY).
In the study measuring LDL-cholesterol (LDL-C, or “bad
cholesterol”) reduction, patients treated with a combination
10 mg of ezetimibe and 10 mg AEGR-733 experienced LDL-C
reductions of 46%. Patients treated with 10 mg of ezetimibe
alone experienced a 20% reduction in LDL-C levels.
Significantly greater reductions in total cholesterol,
non-HDL-cholesterol, Lp(a), and apoB were observed in the
group receiving combined AEGR-733 and ezetimibe. There was no difference in the
rate of discontinuations between the groups treated with
AEGR-733 plus ezetimibe versus those treated with ezetimibe
alone.
In a separate analysis of these data, the ability of AEGR-733 alone
or in combination with ezetimibe was assessed for its
ability to cause weight loss.
Over the course of this study, patients were
counseled on a low fat/low cholesterol diet but with no
emphasis on total calories or weight reduction. Drug treatment
consisted of ezetimibe alone (10 mg), AEGR-733 in escalating
doses at 5 mg, then 7.5 mg, then 10 mg, or a combination of
the two drugs for 12 weeks. Weight was monitored over the
course of the study.
By 12 weeks, subjects receiving ezetimibe alone experienced
weight loss of about 0.2 kg; those receiving AEGR-733
monotherapy about 0.7 kg, and subjects receiving combined
AEGR-733 plus ezetimibe, about 1.4 kg. The reduction in
weight was statistically significant from baseline for
patients receiving combination therapy. Weight loss was not
significantly greater for the combination group versus
ezetimibe alone and was greater in those patients with a
higher baseline body mass index.
A tendency toward
greater effects on weight loss was consistently seen in the
AEGR-733 in combination with ezetimibe than with either
treatment alone.
“These trial results support the LDL-cholesterol lowering
effects of AEGR-733 to clinically relevant target levels,”
said Jerry Wisler, Aegerion
Pharmaceuticals’ President and Chief Executive Officer. “In
addition, there are a considerable number of patients that
cannot tolerate statin therapy and have few other avenues
for robust cholesterol reduction.
We believe that these results demonstrate that the
combination of AEGR-733 and ezetimibe could benefit this
patient population. In addition, the potential for patients
to lose weight may represent another benefit of the
MTP-inhibitor class of compounds.”
Other presentations about AEGR-733 included an oral
presentation on the drug candidate’s effect on single-dose
pharmacokinetics of ezetimibe, and two poster presentations,
one on its effects on single-dose fenofibrate (TriCorŽ,
Abbott) pharmacokinetics, and one on its impact on statin
pharmacokinetics. These trials demonstrated that 10 mg of
AEGR-733 does not result in clinically meaningful drug-drug
interactions with five commonly prescribed lipid lowering
compounds, opening the possibility for future trials and use
of AEGR-733 with these compounds. Additionally, AEGR-733 10
mg resulted in reductions in LDL-C of 20-42% after only
seven days of treatment in these 5 patient cohorts.
* ZetiaŽ
(ezetimibe) is a registered trademark of MSP Singapore
Company, LLC.
About AEGR-733
AEGR-733 is a novel proprietary MTP-inhibitor under
development for the treatment of dyslipidemia (abnormal
lipid levels in the bloodstream). Inhibiting the MTP enzyme
reduces blood levels of cholesterol and triglyceride by
limiting the production of lipoproteins from the intestine
and liver. In the United States alone, nearly 100 million
adults have total blood cholesterol values of 200 mg/dL and
higher, and 34.5 million have levels of 240 and above.
Current guidelines recommend that appropriate LDL levels in
patients at high risk of cardiovascular disease should be
less than 100 mg/dL, or below 70 mg/dL for very high-risk
patients. Under these guidelines, 36 million people would be
eligible for treatment. Standard therapies, such as statins
and cholesterol absorption inhibitors, do not effectively
lower LDL-C to target levels in a significant number of
patients.
About Aegerion
Pharmaceuticals, Inc.
Aegerion Pharmaceuticals, Inc. is a privately held specialty
pharmaceutical company focused on the development and
commercialization of promising pharmaceuticals to treat
cardiovascular and metabolic disease. The Company’s initial
focus is on hyperlipidemia. Its most advanced products have
demonstrated significant LDL lowering activity in human
trials and are currently in Phase II testing.
Contact
Kate Childress,
Vox Medica Health-care Public Relations Group
(t) 215-238-8500 ext 1107
(e)
kchildress@voxmedica.com
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