Amgen has presented more positive late-stage data on its new cholesterol drug evolocumab.
The top-line results came from the Phase III GAUSS-2 trial evaluating evolocumab in 307 patients with high cholesterol who cannot tolerate statins. The data from the study, which compared the Amgen monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9) with Merck & Co’s Zetia (ezetimibe), showed that evolocumab significantly reduced ‘bad’ low-density lipoprotein cholesterol (LDL-C).
The mean percentage reductions in LDL-C, compared to Zetia, were consistent with results observed in the Phase II GAUSS study, Amgen noted. The latter demonstrated that evolocumab led to 51% reduction in LDL-C levels and 63% when combined with Zetia versus a 15% decline for the Merck drug alone.
Amgen R&D chief Sean Harper said the positive GAUSS-2 results “suggest that evolocumab may offer a new lipid-lowering treatment to meet an important medical need for high-risk patients who cannot tolerate effective doses of statins”. There is much interest in the PCSK9 inhibitor class which blocks a protein that reduces the liver’s ability to remove LDL-C from the blood and the evolocumab programme consists of 13 studies, comprising more than 28,000 patients.
Full details from GAUSS-2 will be submitted to a future medical conference and for publication.
