Amgen's AMG 145 meets in Phase III hyperlipidemia trial

Amgen Inc. (NASDAQ:AMGN) said subcutaneous evolocumab ( AMG 145) given monthly at 420 mg or every two weeks at 140 mg each met the co-primary endpoints in the Phase III MENDEL-2 trial to treat hyperlipidemia. Monthly evolocumab and evolocumab every two weeks led to a greater percent reduction in LDL-C from baseline to week 12, a co-primary endpoint, and a greater mean percent reduction in LDL-C from baseline to weeks 10 and 12, a co-primary endpoint, compared to both placebo and once-daily oral Zetia ezetimibe from Merck & Co. Inc. (NYSE:MRK). The double-blind, international trial enrolled 614 patients with high cholesterol -- defined as LDL-C levels of 100 mg/dL or greater but less than 190 mg/dL -- who were not receiving lipid-lowering therapy. Amgen is not disclosing detailed data from the trial.

Data from MENDEL-2 are the first data to be reported from Amgen's Phase III program for evolocumab, which comprises 13 trials. Next quarter, the company plans to report data from three more trials in the program. Evolocumab is a human mAb against proprotein convertase subtilisin/kexin type 9 (PCSK9). ...