Amgen announced detailed data from its Phase 3 TESLA study evaluating evolocumab (AMG 145) in patients with homozygous familial hypercholesterolemia (HoFH). Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9).
TESLA (Trial Evaluating PCSK9 Antibody in Subjects with LDL Receptor Abnormalities) is a two-part Phase 2/3 trial designed to evaluate the safety, tolerability and efficacy of evolocumab. The Phase 2 12-week, open-label, single-arm, multicenter part of the trial (TESLA Part A) evaluated eight patients with HoFH who were on stable drug therapy for ≥4 weeks. Patients received evolocumab 420mg subcutaneous once monthly for a minimum of 12 weeks, followed by every two weeks for another 12 weeks. The primary endpoint was the percent reduction from baseline in LDL-C at week 12.
The Phase 3 12-week, double-blind, randomized, placebo-controlled, multicenter part of the trial (TESLA Part B) evaluated evolocumab compared to placebo in 49 adults and adolescents ≥12 years with HoFH (LDL-C >130mg/dL) who were on a stable dose of statin therapy and other lipid-lowering medications. Patients were randomized to evolocumab 420mg subcutaneous monthly or placebo subcutaneous monthly. The primary endpoint was the percent reduction from baseline in LDL-C at week 12.
Phase 3 data from the TESLA study showed that adding evolocumab 420mg subcutaneous monthly to a stable dose of statin therapy and other lipid-lowering medications significantly reduced LDL-C by 31% (P<0.001) from baseline at week 12 compared to placebo.
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