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Aegerion Pharmaceuticals Announces Interim Lomitapide
(AEGR-733) Phase III Data Demonstrates Significant Lowering
of LDL Cholesterol with Promising Hepatic Safety Profile
Webcast of Company-Sponsored Symposium to Review Clinical Data
Scheduled for June 16th 2009, 12:30-2:00 pm ET at
the ISA (International Symposium on Atherosclerosis) in
Boston, MA
BRIDGEWATER, NJ
(June 15, 2009) — Aegerion Pharmaceuticals, Inc., a
biopharmaceutical company focused on the treatment of
cardiovascular and metabolic disease, today announced interim
data
from its ongoing pivotal Phase III trial involving its lead
cholesterol management compound, lomitapide (AEGR-733), which
is a microsomal triglyceride transfer protein (MTP) inhibitor
small molecule drug.
This pivotal trial is designed to evaluate the
efficacy, safety and tolerability of lomitapide for the
treatment of patients with Homozygous Familial
Hypercholesterolemia (HoFH), a rare and extremely serious
condition resulting in severely elevated levels of low-density
lipoprotein cholesterol (LDL-C), which leads to
life-threatening cardiovascular events.
Patients afflicted by this condition face a severely
curtailed life expectancy and limited treatment options.
Preliminary data from this trial indicate that
lomitapide significantly reduced patients’ LDL-C vs. baseline,
was well tolerated and demonstrated a promising safety
profile, including low levels of hepatic fat accumulation.
There are 19 patients currently enrolled in the ongoing Phase
III trial, which is studying lomitapide in HoFH patients, and
the interim analysis examined 10 patients who had been in the
trial and on lomitapide for a minimum of six months.
In this trial, patients are titrated up to a maximum
tolerated dose of lomitapide (up to 60 mg/day).
On average, at their maximum tolerated dose, these 10
patients have experienced an additional reduction in LDL-C of
44% on top of existing background therapy.
Average baseline LDL-C levels in this trial were 351
mg/dl and four of the 10 patients achieved an LDL-C level
below 100 mg/dl. The reduction in LDL-C levels is consistent
with the more than 50% reduction seen when lomitapide was used
as a monotherapy in a separate Phase II study, the results of
which were published in the
New England Journal of
Medicine in January 2007.
This trial continues to suggest a promising safety and
tolerability profile.
Of the 19 patients currently enrolled in the trial, two
have discontinued due to GI side effects.
There have been no discontinuations due to liver enzyme
elevations. The
trial also includes magnetic resonance spectroscopy to
quantify the level of the patients’ hepatic fat.
The average hepatic fat level after six months of
treatment was approximately 8%.
This preliminary data compares favorably to what the
Company believes are the relevant clinical benchmarks for
hepatic fat.
Bill Sasiela, Chief Medical Officer of Aegerion
Pharmaceuticals, said, “We are pleased with these promising
interim results that suggest the ability of lomitapide to
significantly and safely lower the LDL-C levels of the most
severe and refractory patients.
We are hopeful that these results will continue over
the course of this pivotal Phase III trial and believe that
lomitapide could become an important part of the treatment
regimen for severe dyslipidemic patients who have limited
treatment options today. Importantly, while this trial focuses
on the most severe patients, we are continuing to develop
lomitapide for other appropriate populations, including
patients with severe, refractory heterozygous familial
hypercholesterolemia, such as those eligible for lipid
apheresis.”
In conjunction with the ISA in Boston, MA, an Aegerion-sponsored
Symposium to review its clinical data is scheduled for June
16th 2009 from 12:30-2:00 pm ET at the Sheraton Boston Hotel
in the Republic Ballroom. The Symposium will be webcast and
can be accessed through the following link:
http://psav.mediasite.com/psav/Viewer/?peid=6aa374dc25084161a6be28cf6557de32
About LOMITAPIDE
(AEGR-733)
Lomitapide (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.
About Aegerion
Pharmaceuticals, Inc.
Aegerion Pharmaceuticals, Inc. is a privately held
biopharmaceutical company focused on the development and
commercialization of promising pharmaceuticals to treat
cardiovascular and metabolic disease. The Company’s primary
focus is on hyperlipidemia. Its most advanced products have
demonstrated significant LDL lowering activity in human trials
and are currently in Phase III testing.
Company Contact:
Aegerion Pharmaceuticals, Inc.
Will Lewis, Co-Founder and Chief Financial Officer
(908) 707-2100
Media Contact:
Sard Verbinnen & Co.
Jim Barron/Lesley Bogdanow/Nick Lawler
(212) 687-8080
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