Amgen's AMG 145 meets in third Phase III trial

Amgen Inc. (NASDAQ:AMGN) reported data on Thursday from a third Phase III trial evaluating subcutaneous evolocumab ( AMG 145) to treat hyperlipidemia. In the GAUSS-2 trial, evolocumab met the co-primary endpoints of a greater percent reduction in LDL-C from baseline to week 12 and a greater mean percent reduction in LDL-C from baseline to weeks 10 and 12 vs. once-daily oral Zetia ezetimibe from Merck & Co. Inc. (NYSE:MRK). The double-blind international trial enrolled 307 patients with high cholesterol who could not tolerate effective doses of two or more different statins due to muscle-related side effects.

Last month, Amgen reported that evolocumab met the primary endpoints in the Phase III MENDEL-2 and DESCARTES trials. Amgen's Phase III program for evolocumab comprises 13 trials; the company plans to report data from two more trials this quarter. Evolocumab is a human mAb against proprotein convertase subtilisin/kexin type 9 (PCSK9) (see BioCentury Extra, Dec. 19, 2013). ...