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Updated: Jul 13, 2026

Using Human Induced Pluripotent Stem Cell-derived Hepatocyte-like Cells for Drug Discovery
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Antisense apolipoprotein B therapy: where do we stand?

Fatima Akdim1, Erik S G Stroes, John J P Kastelein

  • 1Department of Vascular Medicine, Academic Medical Centre, University of Amsterdam, The Netherlands.

Current Opinion in Lipidology
|July 11, 2007
PubMed
Summary

ISIS 301012, an antisense oligonucleotide, effectively lowers apolipoprotein B-100 and LDL-cholesterol. This novel lipid-lowering agent also reduces triglycerides, with promising safety but requiring longer trials.

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Published on: January 28, 2021

Area of Science:

  • Pharmacology
  • Cardiovascular Medicine
  • Molecular Biology

Background:

  • Antisense oligonucleotides (ASOs) are therapeutic agents designed to reduce specific messenger RNA (mRNA) levels, thereby decreasing protein synthesis.
  • Apolipoprotein B-100 (ApoB-100) is a key protein synthesized in the liver and is a primary target for lipid-lowering therapies.
  • ASOs demonstrate preferential distribution to the liver, making them suitable for targeting hepatic protein synthesis.

Purpose of the Study:

  • To evaluate the efficacy and safety of ISIS 301012, an antisense oligonucleotide targeting ApoB-100 synthesis.
  • To assess the potential of ISIS 301012 as a lipid-lowering agent, particularly for reducing ApoB-100 and low-density lipoprotein cholesterol (LDL-C).

Main Methods:

  • Administration of ISIS 301012 as monotherapy or in combination with statins.
  • Clinical trials involving healthy volunteers and patients with mild dyslipidemia.
  • Monitoring of lipid profiles, including ApoB-100, LDL-C, and triglycerides.
  • Assessment of safety and tolerability, including injection-site reactions and liver function tests.

Main Results:

  • ISIS 301012 demonstrated significant reductions in ApoB-100 and LDL-C levels.
  • The compound also showed a notable decrease in plasma triglyceride levels.
  • Tolerability was generally encouraging, with mainly mild injection-site reactions and rare liver-function test abnormalities observed.
  • Initial safety data were derived from studies with a limited number of participants.

Conclusions:

  • ISIS 301012 shows promising efficacy in reducing ApoB-100, LDL-C, and triglycerides, based on preclinical and early clinical data.
  • While generally well-tolerated, potential safety concerns include increased liver function tests.
  • Longer-duration clinical trials are necessary to further establish the long-term safety profile of ISIS 301012, particularly regarding hepatic effects.