PCSK9 inhibitor evolocumab meets main goals in phase 3 trial
The experimental PCSK9 inhibitor evolocumab met the co-primary endpoints in the Phase 3 GAUSS-2 (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-2) trial.
Evolocumab is an investigational fully human monoclonal antibody directed at proprotein convertase subtilisin/kexin type 9 (PCSK9).
In the GAUSS-2 study, 307 hyperlipidemic patients who cannot tolerate statin therapy were randomised to receive subcutaneous evolocumab 140 mg every two weeks or 420 mg monthly with oral placebo or oral ezetimibe with subcutaneous placebo. The primary endpoints were the percent reduction from baseline in LDL-C at week 12 and the mean percent reduction from baseline in LDL-C at weeks 10 and 12.
Safety was generally balanced across the treatment arms. The most common adverse events were headache (7.8% in evolocumab group vs. 8.8% in ezetimibe group), myalgia (7.8% vs. 17.% with ezetimibe), pain in extremity (6.8% vs. 1.0%) and muscle spasms (6.3% vs. 3.9%).
Sean Harper, executive vice president of R&D at Amgen, 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."
Last month, Amgen also revealed that the PCSK9 inhibitor was associated with greater reductions in LDL-C levels than ezetimibe and atorvastatin after 52 weeks of treatment.