Amgen has announced positive top-line results from its GAUSS-2  trial of evolocumab (AMG 145) for the treatment of high cholesterol in patients who cannot tolerate statins. Evolocumab is a fully human monoclonal antibody that that is designed to bind to proprotein convertase subtilisin/kexin type 9 (PCSK9) proteins that target LDL receptors and inhibit PCSK9 from adhering to LDL receptors on the surface of the liver.

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The GAUSS-2 (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-2) trial enrolled 307 patients with high cholesterol who could not tolerate effective doses of at least two different statins due to muscle-related side effects.  Patients were randomized and received one of four treatments: subcutaneous evolocumab 140mg every two weeks and oral placebo daily; subcutaneous evolocumab 420mg monthly and oral placebo daily; subcutaneous placebo every two weeks and oral ezetimibe 10mg daily; or subcutaneous placebo monthly and oral ezetimibe 10mg daily.

Evolocumab achieved its co-primary endpoints of percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at week 12 and the mean percent reduction from baseline in LDL-C at weeks 10 and 12. The mean percent reductions in LDL-C for patients taking evolocumab compared to ezetimibe were consistent with the Phase 2 GAUSS study results.

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