Amgen’s evolocumab beats Zetia in Ph III GAUSS-2 trial for cholesterol reduction

USA-based Amgen (Nasdaq: AMGN), the world’s largest independent biotech firm, yesterday revealed positive results from the Phase III GAUSS-2 (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-2) trial evaluating evolocumab.

The study was in patients with high cholesterol who cannot tolerate statins and met its co-primary endpoints: the 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, or "bad" cholesterol, compared to ezetimibe (Zetia, from Merck & Co) were consistent with results observed in the Phase II GAUSS trial.

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.