ReviewMyocardial Infarction

Cell type–specific microRNA therapies for myocardial infarction

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Science Translational Medicine  10 Feb 2021:
Vol. 13, Issue 580, eabd0914
DOI: 10.1126/scitranslmed.abd0914

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  • RE: First-in-human study of an antisense oligonucleotide targeting miR-132 in chronic heart failure patients
    • Bohao Liu, MD/PhD Student, Columbia University
    • Other Contributors:
      • Bryan Wang, MD/PhD Student, Columbia University

    We thank Dr. Thum for the update with additional information on the antisense oligonucleotide targeting miR-132 currently in clinical development. This work is indeed an important step in the development of microRNA therapeutics in cardiac disease, for the first time demonstrating the safety of an agent in human patients. Additionally, we were impressed by the comprehensiveness of the study which included considerations of oligonucleotide chemistry and route of delivery. We hope this study will serve as a model for the future development of microRNA therapies and we eagerly await the results of future clinical trials which may demonstrate the efficacy of CDR132L in the treatment of heart failure.

    Competing Interests: None declared.
  • First-in-human study of an antisense oligonucleotide targeting miR-132 in chronic heart failure patients

    With great interest we have read the review article "Cell type–specific microRNA therapies for myocardial infarction" by Liu and colleages. Here they mention an ongoing study on the miRNA inhibitor CDR132L in heart failure patients ( NCT04045405). In fact, that study carried out by Cardior Pharmaceuticals GmbH, a spinoff company of Hannover Medical School in Germany, was recently published in the European Heart Journal (see below for full reference) and we aim here to give a short overview of the findings.
    The aim of this world-wide first study of an antisense oligonucleotide in heart failure patients (Phase 1b study) was to assess safety, pharmacokinetics, target engagement, and exploratory pharmacodynamic effects of CDR132L in patients on standard-of-care therapy for chronic ischaemic HF in a randomized, placebo-controlled, double-blind, dose-escalation study (NCT04045405). Twenty-eight patients were randomized to receive CDR132L (0.32, 1, 3, and 10 mg/kg body weight) or placebo (0.9% saline) in two intravenous infusions, 4 weeks apart in four cohorts of seven (five verum and two placebo) patients each. CDR132L was safe and well tolerated, without apparent dose-limiting toxicity. A pharmacokinetic/pharmacodynamic dose modelling approach suggested an effective dose level at ≥1 mg/kg CDR132L. CDR132L treatment resulted in a dose-dependent, sustained miR-132 reduction in plasma. Patients given CDR132L ≥1 mg/kg displayed a median 23.3% NT-pro...

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    Competing Interests: Founder and Shareholder of Cardior Pharmaceuticals GmbH

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