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siRNA - Small Interfering RNAs02:30

siRNA - Small Interfering RNAs

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Small interfering RNAs, or siRNAs, are short regulatory RNA molecules that can silence genes post-transcriptionally, as well as the transcriptional level in some cases. siRNAs are important for protecting cells against viral infections and silencing transposable genetic elements.
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RNA interference (RNAi) is a cellular mechanism that inhibits gene expression by suppressing its transcription or activating the RNA degradation process. The mechanism was discovered by Andrew Fire and Craig Mello in 1998 in plants. Today, it is observed in almost all eukaryotes, including protozoa, flies, nematodes, insects, parasites, and mammals. This precise cellular mechanism of gene silencing has been developed into a technique that provides an efficient way to identify and determine the...
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RNA interference (RNAi) is a process in which a small non-coding RNA molecule blocks the post-transcriptional expression of a gene by binding to its messenger RNA (mRNA) and preventing the protein from being translated.
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Updated: May 16, 2025

Isolation of High-density Lipoproteins for Non-coding Small RNA Quantification
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Lepodisiran - A Long-Duration Small Interfering RNA Targeting Lipoprotein(a).

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Lepodisiran effectively reduced lipoprotein(a) levels in patients with atherosclerotic cardiovascular disease. This small interfering RNA therapy demonstrated significant, dose-dependent reductions in serum lipoprotein(a) concentrations.

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Area of Science:

  • Cardiovascular Medicine
  • Pharmacology
  • RNA Therapeutics

Background:

  • Elevated lipoprotein(a) [Lp(a)] levels are a known risk factor for atherosclerotic cardiovascular disease (ASCVD).
  • The safety and efficacy of lepodisiran, an extended-duration small interfering RNA (siRNA) targeting hepatic Lp(a) synthesis, were previously unknown.

Purpose of the Study:

  • To evaluate the safety and efficacy of lepodisiran in reducing serum lipoprotein(a) concentrations.
  • To determine the dose-response relationship of lepodisiran in a randomized controlled trial.

Main Methods:

  • 320 participants were randomized to receive lepodisiran (16 mg, 96 mg, or 400 mg) or placebo via subcutaneous injection.
  • The primary endpoint was the time-averaged percent change from baseline in serum Lp(a) concentration from day 60 to day 180, adjusted for placebo.

Main Results:

  • Lepodisiran demonstrated significant, dose-dependent reductions in serum Lp(a) levels.
  • Placebo-adjusted reductions ranged from -40.8% (16 mg) to -93.9% (400 mg) between days 60-180.
  • Adverse events were generally mild, with dose-dependent injection-site reactions observed.

Conclusions:

  • Lepodisiran effectively reduced mean serum lipoprotein(a) concentrations within 60 to 180 days post-administration.
  • The study supports lepodisiran as a potential therapeutic agent for managing elevated Lp(a) levels and reducing ASCVD risk.