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Aegerion Pharmaceuticals Announces Final Lomitapide
(AEGR-733) Phase II Data
Results Confirm Preliminary Data and Demonstrate
Strong Efficacy, Safety and Tolerability Profile of Lomitapide
BRIDGEWATER, NJ
(June 16, 2009) — Aegerion Pharmaceuticals, Inc., a
biopharmaceutical company focused on the treatment of
cardiovascular and metabolic disease, today announced final
data
from three separate Phase II trials involving its lead
cholesterol management compound, lomitapide (AEGR-733), which
is a microsomal triglyceride transfer protein inhibitor
(MTP-I) small molecule drug.
The final data was recently presented at the American
Diabetes Association’s “69th Scientific Sessions”
in New Orleans,
LA on June 7, 2009 and the International Symposium
on Atherosclerosis (ISA) in Boston, MA
on June 15, 2009.
The three trials ranged in duration from 8 to 12 weeks and
collected clinical data on more than 460 patients who suffer
from dyslipidemia, a condition in which there are abnormal
levels of lipids in the bloodstream. All three Phase II trials
examined the efficacy, safety and tolerability of lomitapide
when administered in low doses, ranging from 2.5mg to 10mg,
both alone and in combination with lipid lowering therapies
(LLTs) such as Lipitor, Zetia and fenofibrate.
The final data confirm the preliminary results Aegerion
announced in November 2008 and demonstrate the strong
efficacy, safety and tolerability profile of lomitapide,
including:
·
Significant reductions in patients’ low-density-lipoprotein
cholesterol (LDL-C) when administered at the high end of the
tested dose range; patients experienced reductions of up to
35% vs. baseline when used as a monotherapy and up to 66% from
baseline in combination with Lipitor
·
Good additivity in LDL-C reduction when combined with Zetia
and fenofibrate
·
Strong decreases in triglyceride levels of up to 40% when used
as a monotherapy and up to 50% in combination with Lipitor
·
Weight loss of up to 3.0% in generally overweight patients
(BMIs of 25-30 kg/m2) from the study after 12 weeks
on therapy
·
A rate of discontinuation due to liver function test (LFT)
elevations of less than 2.0%
·
Modest increases in hepatic fat with mean levels of 5.1-9.8%
and median levels of 2.4-8.0%
·
Minimal gastrointestinal adverse event discontinuations (less
than 5.0%) when dose titration is utilized
Bill Sasiela, Chief Medical Officer of Aegerion
Pharmaceuticals, said, “We are pleased to receive confirmation
of our original findings from November, which suggest that
lomitapide can safely and effectively lower LDL-C and
triglycerides in patients with elevated lipids. Importantly,
the full collection of Phase II trials conducted in the low
end of lomitapide’s dose range, which involved nearly 550
patients, indicate that patients can achieve significant
reductions in LDL-C when using lomitapide with statin
therapies like Lipitor.
Additionally, these data show that combining lomitapide
with other non-statin drugs like Zetia could provide
meaningful LDL-C reductions in patients that cannot tolerate
statin therapy.
In both cases, we see an improved safety profile over prior
high dose MTP-I development efforts.”
As announced on June 15, 2009, Aegerion is currently
conducting a Phase III trial 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 LDL
cholesterol which leads to life-threatening cardiovascular
events. The
preliminary data from the trial indicate statistically
significant reductions in patients’ LDL-C vs. baseline, while
at the same time reporting a promising safety and tolerability
profile, including low levels of hepatic fat accumulation. For
more information on this announcement, please visit
www.aegerion.com.
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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