Reduction in lipoprotein-associated apoC-III levels following volanesorsen therapy: phase 2 randomized trial results

J Lipid Res. 2016 Apr;57(4):706-13. doi: 10.1194/jlr.M066399. Epub 2016 Feb 4.

Abstract

Elevated apoC-III levels predict increased cardiovascular risk when present on LDL and HDL particles. We developed novel high-throughput chemiluminescent ELISAs that capture apoB, lipoprotein (a) [Lp(a)], and apoA-I in plasma and then detect apoC-III on these individual lipoproteins as apoCIII-apoB, apoCIII-Lp(a), and apoCIII-apoAI complexes, respectively. We assessed the effects on these complexes of placebo or 100-300 mg volanesorsen, a generation 2.0+ antisense drug that targets apoC3 mRNA in patients with hypertriglyceridemia, including familial chylomicronemia syndrome (n = 3), volanesorsen monotherapy (n = 51), and as add-on to fibrate (n = 26), treated for 85 days and followed for 176 days. Compared with placebo, volanesorsen was associated with an 82.3 ± 11.7%, 81.3 ± 15.7%, and 80.8 ± 13.6% reduction in apoCIII-apoB, apoCIII-Lp(a), and apoCIII-apoA-I, respectively (300 mg dose;P< 0.001 for all), at day 92. Strong correlations in all assay measures were noted with total plasma apoC-III, chylomicron-apoC-III, and VLDL-apoC-III. In conclusion, novel high-throughput ELISAs were developed to detect lipoprotein-associated apoC-III, including for the first time on Lp(a). Volanesorsen uniformly lowers apoC-III on apoB-100, Lp(a), and apoA-I lipoproteins, and may be a potent agent to reduce triglycerides and cardiovascular risk mediated by apoC-III.

Keywords: antisense oligonucleotides; apolipoprotein C-III; cardiovascular disease; familial chylomicronemia syndrome; hypertriglyceridemia; remnant lipoproteins; triglycerides.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Apolipoprotein C-III / blood*
  • Apolipoprotein C-III / genetics*
  • Apolipoprotein C-III / metabolism
  • Cardiovascular Diseases / blood
  • Cardiovascular Diseases / genetics
  • Cardiovascular Diseases / therapy
  • Female
  • Humans
  • Male
  • Middle Aged
  • Oligonucleotides, Antisense / genetics*
  • Oligonucleotides, Antisense / therapeutic use*
  • RNA, Messenger / genetics
  • Triglycerides / blood

Substances

  • Apolipoprotein C-III
  • Oligonucleotides, Antisense
  • RNA, Messenger
  • Triglycerides