{"id":6196,"date":"2026-02-09T17:21:36","date_gmt":"2026-02-09T14:21:36","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=6196"},"modified":"2026-02-09T17:21:38","modified_gmt":"2026-02-09T14:21:38","slug":"solid-biosciences-aligns-with-fda-on-sgt-003-phase-3-trial-design-for-duchenne-muscular-dystrophy-gene-therapy","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/fr\/solid-biosciences-aligns-with-fda-on-sgt-003-phase-3-trial-design-for-duchenne-muscular-dystrophy-gene-therapy\/","title":{"rendered":"Solid Biosciences s&#039;aligne sur FDA dans le cadre de l&#039;essai de phase 3 SGT-003 pour la th\u00e9rapie g\u00e9nique de la dystrophie musculaire de Duchenne"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Solid Biosciences a annonc\u00e9 une mise \u00e0 jour r\u00e9glementaire positive de sa r\u00e9cente r\u00e9union de type C avec la Food and Drug Administration am\u00e9ricaine (FDA) qui soutient la poursuite du d\u00e9veloppement du SGT-003 en tant que traitement potentiel de la dystrophie musculaire de Duchenne.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>IMPACT DUCHENNE\u00a0: La soci\u00e9t\u00e9 s\u2019est associ\u00e9e \u00e0 FDA concernant la conception d\u2019un essai de phase\u00a03 randomis\u00e9, en double aveugle et contr\u00f4l\u00e9 par placebo \u2013<\/li>\n\n\n\n<li>IMPACT DUCHENNE : La soci\u00e9t\u00e9 pr\u00e9voit l&#039;administration de la premi\u00e8re dose aux participants au premier trimestre 2026 \u2013<\/li>\n\n\n\n<li>La soci\u00e9t\u00e9 pr\u00e9voit des r\u00e9unions suppl\u00e9mentaires avec le FDA au premier semestre 2026 afin de s&#039;accorder sur une voie d&#039;approbation acc\u00e9l\u00e9r\u00e9e potentielle pour le SGT-003.<\/li>\n\n\n\n<li>INSPIRE DUCHENNE\u00a0: Le SGT-003 continue d\u2019\u00eatre g\u00e9n\u00e9ralement bien tol\u00e9r\u00e9 avec 36 participants trait\u00e9s au 9 f\u00e9vrier 2026 dans le cadre de l\u2019essai de phase 1\/2 \u2013<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Le comit\u00e9 FDA a convenu que la conception de l&#039;essai \u00e9tait raisonnable, notamment\u00a0: la population de patients ambulatoires \u00e2g\u00e9s de 7 \u00e0 moins de 12\u00a0ans, le crit\u00e8re d&#039;\u00e9valuation principal de changement par rapport \u00e0 la valeur de r\u00e9f\u00e9rence de la vitesse du temps de lever (TTR) \u00e0 partir de la position couch\u00e9e \u00e9valu\u00e9e \u00e0 18\u00a0mois et d&#039;autres crit\u00e8res d&#039;\u00e9valuation secondaires cl\u00e9s.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Suivre cette page<\/strong>&nbsp;&gt;&gt;&gt;&nbsp;<a href=\"https:\/\/dmdwarrior.com\/fr\/dmd-therapies\/\" target=\"_blank\" rel=\"noreferrer noopener\">Tous les essais cliniques pour la dystrophie musculaire de Duchenne<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Solid Biosciences announced a positive regulatory update from its recent Type C meeting with the U.S. Food and Drug Administration (FDA) that supports the continued advancement of SGT-003 as a potential treatment for Duchenne muscular dystrophy. The FDA agreed that the trial design was reasonable including: the patient population of ambulant participants 7 to &lt;12 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":6197,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[88,110,170,109],"class_list":["post-6196","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-fda","tag-sgt-003","tag-sgt-003-gene-therapy","tag-solid-biosciences"],"subtitle":"Solid a conclu un accord avec le FDA sur la conception globale de l'\u00e9tude pour l'essai clinique de phase 3 randomis\u00e9, en double aveugle et contr\u00f4l\u00e9 par placebo de la soci\u00e9t\u00e9, IMPACT DUCHENNE.","_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/posts\/6196","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/comments?post=6196"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/posts\/6196\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/media\/6197"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/media?parent=6196"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/categories?post=6196"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/tags?post=6196"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}