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Evolocumab meets primary efficacy endpoints in phase 3 study
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Evolocumab, a PCSK9 inhibitor, showed favorable results from a phase 3 trial assessing its efficacy as a cholesterol-lowering therapy in statin-intolerant patients, according to a press release issued by Amgen.
The drug, an investigational fully human monoclonal antibody, achieved its co-primary endpoints of percent reduction from baseline in LDL at 12 weeks, and mean percent reduction in LDL at 10 and 12 weeks.
The multicenter, double blind GAUSS-2 trial included a cohort of 307 patients with high cholesterol who experienced muscle-related side effects when treated with effective doses of at least two different statins. Patients were randomly assigned to one of the following treatment groups:
- Daily oral placebo with 140 mg subcutaneous evolocumab every 2 weeks
- Daily oral placebo with 420 mg subcutaneous evolocumab monthly
- 10 mg orally administered ezetimibe with subcutaneous placebo every 2 weeks
- 10 mg orally administered ezetimibe with subcutaneous placebo monthly
Similar safety results were observed across the four groups, with headache, myalgia, extremity pain and muscle spasms the most common adverse events, according to the release.
The trial is one of 13 phase 3 studies assessing evolocumab, which will include a planned total of more than 28,000 patients. In other trials within the program, the company will also evaluate the efficacy of the drug in combination with statins and as a standalone therapy among patients with hyperlipidemia, as well as among patients with heterozygous and homozygous familial hypercholesterolemia.
Sean E. Harper
“We are pleased to continue to see promising results from the phase 3 studies in our comprehensive development program for evolocumab,” Sean E. Harper, MD, executive vice president of research and development at the company, said in the release. “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.”
Data from GAUSS-2 will be submitted to a future medical conference and for publication, according to the release.