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Evolocumab effectively reduced LDL in phase 3 trial
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Amgen announced that evolocumab met its co-primary efficacy endpoints for the reduction of LDL in the phase 3 MENDEL-2 trial.
Evolocumab (Amgen) is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9).
The randomized, double blind, controlled multicenter MENDEL-2 study was designed to assess the efficacy, safety and tolerability of evolocumab in 614 adults with LDL between 100 mg/dL and 190 mg/dL not treated with lipid-lowering therapy. Participants were randomly assigned to one of six groups to compare two dosing regimens of evolocumab (140 mg every 2 weeks or 420 mg monthly) with placebo and ezetimibe (10 mg daily), according to a press release.
The co-primary endpoints were percent reduction in LDL at 12 weeks and mean percent reduction from baseline at10 and 12 weeks, as compared with placebo and ezetimibe (Zetia, Merck). Results from the MENDEL-2 trial were similar to those observed during the phase 2 MENDEL trial, according to the release.
The most commonly observed adverse events, which occurred in more than 2% of patients assigned evolocumab, included diarrhea, headache, nausea and urinary tract infection. The incidence of adverse events was balanced across the treatment groups.
Sean E. Harper
“Data from the MENDEL-2 monotherapy study in more than 600 patients provide the first of phase 3 results from our comprehensive development program for evolocumab,” Sean E. Harper, MD, executive vice president of research and development for Amgen, stated in the release. “The positive results we have seen with two distinct dosing options suggest that evolocumab may offer a promising approach to treat patients with high cholesterol.”
The company plans to submit the full MENDEL-2 results for publication and presentation at future medical conferences.