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The Lancet Publication Of LAPLACE-TIMI 57 And MENDEL Studies Showed AMG 145 Significantly Reduced LDL Cholesterol
Date:11/6/2012

in LDL-C from baseline for AMG 145 dosed Q4W was 39 percent in the 280 mg group; 43 percent in the 350 mg group; and 48 percent in the 420 mg group compared to five percent increase for placebo.
  • The most commonly reported AEs for AMG 145, were upper respiratory tract infection, nasopharyngitis and diarrhea.
  • "In the MENDEL study, AMG 145 monotherapy showed robust reductions in serum LDL-C with both the Q2W and Q4W dosing regimens in patients with high cholesterol regardless of sex, age, race or cardiovascular risk factors," said Michael Koren, M.D., C.P.I. of Jacksonville Center for Clinical Research. "This study provides support that treatment with AMG 145 may be an alternative approach for LDL-C reduction in patients who cannot take statins."

    These studies are two of four Phase 2 studies of AMG 145 being presented at the American Heart Association Scientific Sessions 2012.

    LAPLACE-TIMI 57 Study Design
    LAPLACE-TIMI 57 (LDL-C Assessment with PCSK9 monoclonaL Antibody inhibition Combined with statin thErapy – Thrombolysis In Myocardial Infarction-57) is a Phase 2 randomized, double-blind, dose-ranging, placebo-controlled study that included eight treatment arms to evaluate the efficacy, safety and tolerability of AMG 145, administered subcutaneously, in 629 patients at risk for cardiovascular disease with LDL-C > 85 mg/dL when added to a stable dose of statin with or without ezetimibe.  Treatment arms included AMG 145 (70 mg, 105 mg and 140 mg) versus placebo Q2W and AMG 145 (280 mg, 350 mg and 420 mg) versus placebo Q4W.  The primary endpoint of the study was the percent change from baseline in LDL-C, measured by preparative ultracentrifugation, at week 12. Secondary efficacy endpoints included the absolute change from baseline in LDL-C at week 12 and the percentage changes from baseline to week 12 in non-high-dens
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