{"id":6359,"date":"2018-03-22T12:41:12","date_gmt":"2018-03-22T12:41:12","guid":{"rendered":"https:\/\/laforcedmd.com\/?p=6359"},"modified":"2022-05-03T18:17:26","modified_gmt":"2022-05-03T18:17:26","slug":"new-dmd-exon-skipping-therapy","status":"publish","type":"post","link":"https:\/\/laforcedmd.com\/en\/new-dmd-exon-skipping-therapy\/","title":{"rendered":"New DMD exon-skipping therapy on the way"},"content":{"rendered":"<p><strong>Following positive results obtained in Phase I\/II trial of SRP-4053 (Golodirsen), Sarepta Therapeutics has announced a plan to submit a new drug application (NDA) for accelerated approval of Golodirsen in patients with Duchenne muscular dystrophy (DMD).<\/strong><\/p>\n<p><strong>According to the results of the clinical study, Golodirsen significantly boosted dystrophin protein production in 25 boys with confirmed deletions of the DMD gene amenable to exon 53 skipping. This mutation affects about 8 percent of all DMD patients.<\/strong><\/p>\n<p>&nbsp;<\/p>\n<h4>What is Golodirsen?<\/h4>\n<p>Golodirsen uses exon-skipping technology and works by binding to exon\u00a053 of the dystrophin sequence to exclude, or skip, this part of the line. This helps produce a smaller but functional form of dystrophin protein.<\/p>\n<p>&nbsp;<\/p>\n<h4>Positive results<\/h4>\n<p>Golodirsen showed the potential to treat Duchenne muscular dystrophy (DMD) in the first clinical trial of DMD patients.\u00a0<a href=\"http:\/\/investorrelations.sarepta.com\/news-releases\/news-release-details\/sarepta-therapeutics-announces-positive-results-its-study\">Press release<\/a><\/p>\n<p>&nbsp;<\/p>\n<h4>Why do we need to skip an exon?<\/h4>\n<p>DMD is caused by specific errors (mutations) in the gene that codes for dystrophin. Dystrophin is a protein that plays a crucial role in the function of muscle cells and protects them from damage as muscles contract and relaxes. These mutations in the dystrophin gene lead to a lack of dystrophin protein in muscles. Without enough dystrophin, muscles gradually grow weaker until they can\u2019t move at all, and eventually, breathing and heart function are lost.<\/p>\n<p>The condition is universally fatal, and death usually occurs before the age of 30, generally due to respiratory or cardiac failure.<\/p>\n<p>&nbsp;<\/p>\n<h4>More about Golodirsen<\/h4>\n<p>Golodirsen uses Sarepta\u2019s proprietary phosphorodiamidate morpholino oligomer (PMO)<strong>*<\/strong> chemistry and exon-skipping technology to skip exon\u00a053 of the\u00a0<em>DMD<\/em>\u00a0gene. Golodirsen is designed to bind to exon\u00a053 of dystrophin pre-mRNA, resulting in exclusion, or \u201cskipping,\u201d of this exon during mRNA processing in patients with genetic mutations that are amenable to exon\u00a053 skipping. Exon skipping is intended to allow for the production of an internally truncated but functional dystrophin protein.<\/p>\n<p>Golodirsen is one of the investigational candidates currently being evaluated in the ESSENCE study, a global, randomized, double-blind, placebo-controlled study evaluating efficacy and safety in patients amenable to skipping exons\u00a045 or 53.<\/p>\n<p><em><strong>*<\/strong>a phosphorodiamidate Morpholino oligomer\u00a0(PMO), is a type of\u00a0oligomer\u00a0molecule\u00a0(colloquially, an\u00a0oligo) used in\u00a0molecular biology\u00a0to modify\u00a0gene expression.\u00a0<\/em><\/p>\n<p>&nbsp;<\/p>\n<h4>More about the clinical trial<\/h4>\n<p><b>\u00a0<\/b>ESSENCE: Phase\u00a0III Study<\/p>\n<p><strong>Purpose:<\/strong>\u00a0The main objective of this study is to evaluate the efficacy of SRP-4045 and SRP-4053 compared to placebo in Duchenne muscular dystrophy (DMD) patients with out-of-frame deletion mutations amenable to skipping exon\u00a045 and exon\u00a053, respectively.<\/p>\n<p><strong>Location:<\/strong>\u00a0United States, Europe, Canada, Israel<\/p>\n<p>For more information, please visit\u00a0<a href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT02500381?term=NCT02500381&amp;rank=1\">www.clinicaltrials.gov<\/a>\u00a0or\u00a0<span style=\"color: #0000ff;\"><a style=\"color: #0000ff;\" href=\"https:\/\/essencetrial.com\/\">www.essencetrial.com<\/a><\/span><\/p>\n<p>&nbsp;<\/p>\n<h4>Sources:<\/h4>\n<p><span style=\"color: #0000ff;\"><a style=\"color: #0000ff;\" href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02310906\" target=\"_blank\" rel=\"noopener noreferrer\">Clinical Trials<\/a><\/span><\/p>\n<p><span style=\"color: #0000ff;\"><a style=\"color: #0000ff;\" href=\"https:\/\/musculardystrophynews.com\/2017\/09\/11\/dmd-exon-53-skipping-therapy-golodirsen-improves-dystrophin-expression-sarepta-says\/\" target=\"_blank\" rel=\"noopener noreferrer\">Muscular Dystrophy News<\/a><\/span><\/p>\n<p><span style=\"color: #0000ff;\"><a style=\"color: #0000ff;\" href=\"http:\/\/investorrelations.sarepta.com\/news-releases\/news-release-details\/sarepta-therapeutics-announces-plan-submit-new-drug-application\" target=\"_blank\" rel=\"noopener noreferrer\">Investor Relations<\/a><\/span><\/p>\n<p><span style=\"color: #0000ff;\"><a style=\"color: #0000ff;\" href=\"https:\/\/en.wikipedia.org\/wiki\/Morpholino\" target=\"_blank\" rel=\"noopener noreferrer\">Wikipedia<\/a><\/span><\/p>\n<p><span style=\"color: #0000ff;\"><a style=\"color: #0000ff;\" href=\"\/?p=4911\" target=\"_blank\" rel=\"noopener noreferrer\">Portrait of Duchenne &#8211; Exon skipping and gene therapy &#8211; Blog<\/a><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Following positive results obtained in Phase I\/II trial of SRP-4053 (Golodirsen), Sarepta Therapeutics has announced a plan to submit a new drug application (NDA) for accelerated approval of Golodirsen in patients with Duchenne muscular dystrophy (DMD). According to the results of the clinical study, Golodirsen significantly boosted dystrophin protein production in 25 boys with confirmed [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":6372,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[12,17,18],"tags":[],"class_list":["post-6359","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-research","category-treatments"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>New DMD exon-skipping therapy on the way - La Force dmd<\/title>\n<meta name=\"description\" content=\"Sarepta announced a plan to submit a new drug application (NDA) for accelerated approval of Golodirsen, a exon-skipping therapy, for DMD\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/laforcedmd.com\/en\/new-dmd-exon-skipping-therapy\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"New DMD exon-skipping therapy on the way - 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