Aegerion Pharmaceuticals, Inc. Presents Final Results of Phase II Clinical Trials for AEGR-733 at Drugs Affecting Lipid Metabolism (DALM) 2007 ConferenceLead Compound Produces Significant LDL-Cholesterol Reduction and Weight Loss When Combined with Zetia(R) in Hypercholesterolemic Patients
BRIDGEWATER, N.J., Oct. 4 /PRNewswire/ -- 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: Zetia(R)*). The data were presented in two posters at the XVI International Symposium on Drugs Affecting Lipid Metabolism (DALM) (October 04, 2007-7, 2007, New York, NY), jointly sponsored by the Weill Cornell Medical College (New York, NY) and the Giovanni Lorenzini Medical Foundation (Milan, Italy and Houston, TX).
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 (TriCor(R), 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.
* Zetia(R) (ezetimibe) is a registered trademark of MSP Singapore Company, LLC.
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.
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Posted: October 2007