Amgen Reports Data From Phase 3 Studies On Evolocumab

(RTTNews) - Amgen (AMGN) announced new detailed data from two Phase 3 pivotal studies that showed treatment with its novel investigational cholesterol-lowering medication, evolocumab (AMG 145), resulted in a statistically significant reduction in low-density lipoprotein cholesterol (LDL-C) between 37-39 percent, compared to ezetimibe in patients with high cholesterol who cannot tolerate statins (GAUSS-2) and between 55-76 percent compared to placebo when used in combination with statin therapy in patients with high cholesterol (LAPLACE-2).

Results from the two separate Phase 3 studies, GAUSS-2 and LAPLACE-2, were presented today as Late-Breaking Clinical Trials and complement the three Phase 3 studies presented yesterday as Featured Clinical Research at the American College of Cardiology's 63rd Annual Scientific Session.

Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove LDL-C from the blood.

Goal Achievement After Utilizing an Anti-PCSK9 Antibody in StatinIntolerant Subjects-2 or GAUSS-2 study showed that in 307 patients with high cholesterol who could not tolerate effective doses of at least two different statins due to muscle-related side effects, treatment with subcutaneous evolocumab (140 mg every two weeks or 420 mg monthly), significantly reduced mean LDL-C by 37-39 percent from baseline compared to ezetimibe.

Data from the GAUSS-2 study suggest evolocumab could be a promising lipid-lowering treatment for patients with high cholesterol who cannot tolerate effective doses of statins.

LDL-C Assessment with PCSK9 MonoclonaL Antibody Inhibition Combined with Statin ThErapy-2 or LAPLACE-2 tudy showed that in 1,896 patients with high cholesterol (LDL-C >80 mg/dL), treatment with subcutaneous evolocumab (140 mg every two weeks or 420 mg monthly) in combination with different daily doses of statin therapy significantly reduced mean LDL-C by 55-76 percent from baseline compared to placebo and 38-47 percent from baseline compared to ezetimibe.

"The positive results from the LAPLACE-2 study show that adding evolocumab to statin therapy additionally lowers LDL cholesterol levels when added to moderate or high doses of statins," said LAPLACE-2 lead investigator Jennifer Robinson.