{"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\/es\/solid-biosciences-aligns-with-fda-on-sgt-003-phase-3-trial-design-for-duchenne-muscular-dystrophy-gene-therapy\/","title":{"rendered":"Solid Biosciences se alinea con FDA en el dise\u00f1o del ensayo de fase 3 SGT-003 para la terapia g\u00e9nica de la distrofia muscular de Duchenne"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Solid Biosciences anunci\u00f3 una actualizaci\u00f3n regulatoria positiva de su reciente reuni\u00f3n Tipo C con la Administraci\u00f3n de Alimentos y Medicamentos de EE. UU. (FDA) que respalda el avance continuo de SGT-003 como un posible tratamiento para la distrofia muscular de Duchenne.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>IMPACTO DUCHENNE: La empresa se aline\u00f3 con FDA en el dise\u00f1o de un ensayo de fase 3 aleatorizado, doble ciego y controlado con placebo.<\/li>\n\n\n\n<li>IMPACTO DUCHENNE: La compa\u00f1\u00eda prev\u00e9 la primera dosis a los participantes en el primer trimestre de 2026 \u2013<\/li>\n\n\n\n<li>La empresa planea reuniones adicionales con el FDA en el primer semestre de 2026 para alinearse en una posible v\u00eda de aprobaci\u00f3n acelerada para SGT-003.<\/li>\n\n\n\n<li>INSPIRE DUCHENNE: SGT-003 sigue siendo generalmente bien tolerado con 36 participantes dosificados hasta el 9 de febrero de 2026, en el ensayo de fase 1\/2.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">El FDA estuvo de acuerdo en que el dise\u00f1o del ensayo era razonable e inclu\u00eda: la poblaci\u00f3n de pacientes ambulatorios de 7 a &lt;12 a\u00f1os de edad, el criterio de valoraci\u00f3n principal del cambio desde el valor inicial en la velocidad del tiempo de ascenso (TTR) desde la posici\u00f3n supina evaluada a los 18 meses y otros criterios de valoraci\u00f3n secundarios clave.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Sigue esta p\u00e1gina<\/strong>&nbsp;&gt;&gt;&gt;&nbsp;<a href=\"https:\/\/dmdwarrior.com\/es\/dmd-therapies\/\" target=\"_blank\" rel=\"noreferrer noopener\">Todos los ensayos cl\u00ednicos para la distrofia muscular 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"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/posts\/6196","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/comments?post=6196"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/posts\/6196\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/media\/6197"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/media?parent=6196"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/categories?post=6196"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/tags?post=6196"}],"curies":[{"name":"gracias","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}