Aegerion Study Shows Combination Treatment With AEGR-733 And Zetia(R) Reduces LDL Levels By 35% After Four Weeks Of Therapy

Main Category: Cholesterol
Also Included In: Cardiovascular / Cardiology;  Clinical Trials / Drug Trials
Article Date: 16 Nov 2006 - 0:00 PDT

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Aegerion Pharmaceuticals, Inc., a specialty pharmaceuticals company focused on the treatment of cardiovascular and metabolic disease, today announced interim results from its on-going phase II clinical trial involving its lead cholesterol management compound, AEGR-733, alone and in combination with Zetia(R) (ezetimibe). In the study, patients treated with a combination of 10 mg dose of Zetia(R) and 5 mg AEGR-733 achieved a LDL reduction of 35% after 4 weeks. Patients treated with Zetia(R) alone achieved a 20% reduction in LDL cholesterol. There was no difference in discontinuation rates between the patients treated with the combination of AEGR 733 plus 10 mg of Zetia(R) vs. those treated with 10 mg of Zetia(R) alone. In addition, treatment with both 5 mg and 7.5 mg doses of AEGR 733 were shown to be effective as monotherapy (mean LDL- C reductions of 19% and 28%, respectively).

"These results are a demonstration of the potential broad applicability of AEGR-733 in treatment as a monotherapy and in combination with current lipid lowering therapies," commented Fredrick F. Samaha, MD, Associate Professor of Medicine, University of Pennsylvania School of Medicine and the principal investigator for this study. "There is a clear unmet medical need in the management of hypercholesterolemia and this class of compounds, known as MTP-inhibitors, has the potential to play an important role as treatment patterns continue to evolve in the direction of combination therapy."

Final study results for the current trial are expected in the first quarter of 2007. Aegerion plans to initiate several additional Phase II trials in early 2007, including one that will examine the LDL lowering efficacy of various doses of AEGR 733 used in combination with Lipitor(R) vs. the agents used as monotherapy.

About Aegerion Pharmaceuticals

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, including AEGR 733, are microsomal triglyceride transfer protein (MTP) inhibitors that have demonstrated significant LDL lowering activity in human trials. Aegerion has recently licensed a second MTP inhibitor compound, implitapide, and plans to enter additional phase II testing with implitapide in 2007.

Aegerion Pharmaceuticals, Inc.
http://www.aegerion.com/

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