AMG 145: Phase II data

The double-blind, international Phase II GAUSS trial in 160 patients showed that all 3 doses of subcutaneous AMG 145 alone and AMG 145 plus ezetimibe met the primary endpoint of reducing LDL-C from baseline to week 12 vs. placebo plus ezetimibe. Specifically, AMG 145 alone given every 4 weeks led to mean reductions in LDL-C from baseline to week 12 of 41% in the 280 mg dose arm, 43% in the 350 mg dose arm and 51% in the 420 mg dose arm vs. 15 % for placebo (p<0.001 for all). Additionally, 420 mg AMG 145 every 4 weeks plus once-daily ezetimibe led to a mean reduction in LDL-C from baseline to week 12 of 63% vs. placebo plus ezetimibe (p<0.001). On secondary endpoints, Amgen said AMG 145 led to reductions in total cholesterol, non-HDL-C, APOB, and the ratios of total cholesterol/HDL-C and APOB/APOA1. Furthermore, AMG 145 alone reduced lipoprotein(a) (LPA) by 20-26% as monotherapy and by 29% in combination with ezetimibe vs. placebo plus ezetimibe (p<0.01 for all). AMG 145 alone and in combination with ezetimibe also significantly increased HDL-C by 6-12% vs. a 1% reduction for placebo plus ezetimibe (p<0.001). ...