AMG 145 meets hypercholesterolemia endpoints

Amgen Inc. (NASDAQ:AMGN) said subcutaneous AMG 145 met the primary endpoints in a pair of double-blind, international Phase II trials to treat hypercholesterolemia. In the GAUSS study, 280, 350 and 420 mg AMG 145 alone every four weeks each met the primary endpoint of reducing LDL-C from baseline to week 12 (41%, 43% and 51%, respectively) vs. 15% for placebo plus ezetimibe (p<0.0001 for all). In a fifth arm, high-dose AMG 145 plus ezetimibe also met the primary endpoint of reducing LDL-C from baseline to week 12 vs. placebo plus ezetimibe. GAUSS enrolled 160 patients aged 18-75 years with hypercholesterolemia who could not tolerate effective statin doses due to muscle-related side effects.

In RUTHERFORD, 350 and 420 mg doses of AMG 145 given every four weeks each met the primary endpoint of reducing LDL-C from baseline to week 12 (43% and 55% respectively) vs. a 1% increase for placebo (p<0.001 for both). The trial enrolled 168 patients with heterozygous familial hypercholesterolemia (heFH) on a stable dose of statin therapy with or without ezetimibe. ...