Comprehensive review of adverse reactions and toxicology in ASO-based therapies for Duchenne Muscular Dystrophy: From FDA-approved drugs to peptide-conjugated ASO

Duchenne Muscular Dystrophy (DMD) is a devastating X-linked genetic disorder characterized by progressive muscle degeneration due to mutations in the dystrophin gene. This results in the absence or dysfunction of the dystrophin protein, leading to muscle weakness, loss of ambulation, respiratory iss...

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Main Authors: Umme Sabrina Haque, Melissa Kohut, Toshifumi Yokota
Format: Article
Language:English
Published: Elsevier 2024-01-01
Series:Current Research in Toxicology
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Online Access:http://www.sciencedirect.com/science/article/pii/S2666027X24000355
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author Umme Sabrina Haque
Melissa Kohut
Toshifumi Yokota
author_facet Umme Sabrina Haque
Melissa Kohut
Toshifumi Yokota
author_sort Umme Sabrina Haque
collection DOAJ
description Duchenne Muscular Dystrophy (DMD) is a devastating X-linked genetic disorder characterized by progressive muscle degeneration due to mutations in the dystrophin gene. This results in the absence or dysfunction of the dystrophin protein, leading to muscle weakness, loss of ambulation, respiratory issues, and cardiac complications, often leading to premature death. Recently, antisense oligonucleotide (ASO)-mediated exon skipping has emerged as a promising therapeutic strategy for DMD. Notably, the FDA has conditionally approved four ASO therapies for DMD, with numerous others in various stages of clinical development, indicating the growing interest and potential in this field. To enhance ASO-based therapies, researchers have explored the novel concept of conjugating peptides to the phosphorodiamidate morpholino backbone (PMO) of ASOs, leading to the development of peptide-conjugated PMOs (PPMOs). These PPMOs have demonstrated significantly improved pharmacokinetic profiles, potentially augmenting their therapeutic effectiveness. Despite the optimism surrounding ASOs and PPMOs, concerns persist regarding their efficacy and safety. To comprehensively evaluate these therapies, it is imperative to expand patient populations in clinical trials and conduct thorough investigations into the associated risks. This article provides a comprehensive review and discussion of the available data pertaining to adverse reactions and toxicology associated with FDA-approved ASO drugs for DMD. Furthermore, it offers insights into the emerging category of peptide-conjugated ASO drugs those are clinical and preclinical trials, shedding light on their potential benefits and challenges.
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spelling doaj-art-4bc8b59de5f7483da8fd0386aaf8f26c2024-12-14T06:32:52ZengElsevierCurrent Research in Toxicology2666-027X2024-01-017100182Comprehensive review of adverse reactions and toxicology in ASO-based therapies for Duchenne Muscular Dystrophy: From FDA-approved drugs to peptide-conjugated ASOUmme Sabrina Haque0Melissa Kohut1Toshifumi Yokota2Department of Neuroscience, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB T6G 2H7, Canada; Department of Medical Genetics, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB T6G 2H7, CanadaDepartment of Neuroscience, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB T6G 2H7, Canada; Department of Medical Genetics, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB T6G 2H7, CanadaDepartment of Medical Genetics, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB T6G 2H7, Canada; The Friends of Garrett Cumming Research & Muscular Dystrophy Canada HM Toupin Neurological Science Research, Edmonton, AB T6G 2H7, Canada; Corresponding author.Duchenne Muscular Dystrophy (DMD) is a devastating X-linked genetic disorder characterized by progressive muscle degeneration due to mutations in the dystrophin gene. This results in the absence or dysfunction of the dystrophin protein, leading to muscle weakness, loss of ambulation, respiratory issues, and cardiac complications, often leading to premature death. Recently, antisense oligonucleotide (ASO)-mediated exon skipping has emerged as a promising therapeutic strategy for DMD. Notably, the FDA has conditionally approved four ASO therapies for DMD, with numerous others in various stages of clinical development, indicating the growing interest and potential in this field. To enhance ASO-based therapies, researchers have explored the novel concept of conjugating peptides to the phosphorodiamidate morpholino backbone (PMO) of ASOs, leading to the development of peptide-conjugated PMOs (PPMOs). These PPMOs have demonstrated significantly improved pharmacokinetic profiles, potentially augmenting their therapeutic effectiveness. Despite the optimism surrounding ASOs and PPMOs, concerns persist regarding their efficacy and safety. To comprehensively evaluate these therapies, it is imperative to expand patient populations in clinical trials and conduct thorough investigations into the associated risks. This article provides a comprehensive review and discussion of the available data pertaining to adverse reactions and toxicology associated with FDA-approved ASO drugs for DMD. Furthermore, it offers insights into the emerging category of peptide-conjugated ASO drugs those are clinical and preclinical trials, shedding light on their potential benefits and challenges.http://www.sciencedirect.com/science/article/pii/S2666027X24000355DMDEteplirsenGolodirsenViltolarsenCasimersenSRP-5051
spellingShingle Umme Sabrina Haque
Melissa Kohut
Toshifumi Yokota
Comprehensive review of adverse reactions and toxicology in ASO-based therapies for Duchenne Muscular Dystrophy: From FDA-approved drugs to peptide-conjugated ASO
Current Research in Toxicology
DMD
Eteplirsen
Golodirsen
Viltolarsen
Casimersen
SRP-5051
title Comprehensive review of adverse reactions and toxicology in ASO-based therapies for Duchenne Muscular Dystrophy: From FDA-approved drugs to peptide-conjugated ASO
title_full Comprehensive review of adverse reactions and toxicology in ASO-based therapies for Duchenne Muscular Dystrophy: From FDA-approved drugs to peptide-conjugated ASO
title_fullStr Comprehensive review of adverse reactions and toxicology in ASO-based therapies for Duchenne Muscular Dystrophy: From FDA-approved drugs to peptide-conjugated ASO
title_full_unstemmed Comprehensive review of adverse reactions and toxicology in ASO-based therapies for Duchenne Muscular Dystrophy: From FDA-approved drugs to peptide-conjugated ASO
title_short Comprehensive review of adverse reactions and toxicology in ASO-based therapies for Duchenne Muscular Dystrophy: From FDA-approved drugs to peptide-conjugated ASO
title_sort comprehensive review of adverse reactions and toxicology in aso based therapies for duchenne muscular dystrophy from fda approved drugs to peptide conjugated aso
topic DMD
Eteplirsen
Golodirsen
Viltolarsen
Casimersen
SRP-5051
url http://www.sciencedirect.com/science/article/pii/S2666027X24000355
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