{"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\/tr\/solid-biosciences-aligns-with-fda-on-sgt-003-phase-3-trial-design-for-duchenne-muscular-dystrophy-gene-therapy\/","title":{"rendered":"Solid Biosciences, Duchenne Musk\u00fcler Distrofi Gen Terapisi i\u00e7in SGT-003 Faz 3 Klinik \u00c7al\u0131\u015fmas\u0131n\u0131n Tasar\u0131m\u0131nda FDA ile Anla\u015ft\u0131"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Solid Biosciences, ABD G\u0131da ve \u0130la\u00e7 \u0130daresi (FDA) ile yak\u0131n zamanda ger\u00e7ekle\u015ftirilen C Tipi toplant\u0131s\u0131ndan (FDA) olumlu bir d\u00fczenleyici g\u00fcncelleme ald\u0131\u011f\u0131n\u0131 duyurdu; bu g\u00fcncelleme, SGT-003&#039;\u00fcn Duchenne kas distrofisi i\u00e7in potansiyel bir tedavi olarak geli\u015ftirilmesinin devam\u0131n\u0131 destekliyor.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>IMPACT DUCHENNE: \u015eirket, Faz 3 randomize, \u00e7ift k\u00f6r, plasebo kontroll\u00fc klinik \u00e7al\u0131\u015fma tasar\u0131m\u0131 konusunda FDA ile i\u015f birli\u011fi yap\u0131yor.<\/li>\n\n\n\n<li>IMPACT DUCHENNE: \u015eirket, ilk kat\u0131l\u0131mc\u0131 dozlamas\u0131n\u0131n 2026&#039;n\u0131n ilk \u00e7eyre\u011finde yap\u0131lmas\u0131n\u0131 \u00f6ng\u00f6r\u00fcyor.<\/li>\n\n\n\n<li>\u015eirket, SGT-003 i\u00e7in potansiyel h\u0131zland\u0131r\u0131lm\u0131\u015f onay yoluna ili\u015fkin mutabakata varmak amac\u0131yla 2026 y\u0131l\u0131n\u0131n ilk yar\u0131s\u0131nda FDA ile ek toplant\u0131lar yapmay\u0131 planl\u0131yor.<\/li>\n\n\n\n<li>INSPIRE DUCHENNE: SGT-003, Faz 1\/2 \u00e7al\u0131\u015fmas\u0131nda 9 \u015eubat 2026 itibar\u0131yla 36 kat\u0131l\u0131mc\u0131da genel olarak iyi tolere edilmeye devam etmektedir.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">FDA, a\u015fa\u011f\u0131daki unsurlar\u0131 i\u00e7eren \u00e7al\u0131\u015fma tasar\u0131m\u0131n\u0131n makul oldu\u011funu kabul etti: 7 ila &lt;12 ya\u015f aras\u0131 ayakta durabilen kat\u0131l\u0131mc\u0131lardan olu\u015fan hasta pop\u00fclasyonu, 18. ayda de\u011ferlendirilen s\u0131rt\u00fcst\u00fc pozisyondan kalkma s\u00fcresindeki (TTR) ba\u015flang\u0131\u00e7 de\u011ferine g\u00f6re de\u011fi\u015fimin birincil sonlan\u0131m noktas\u0131 ve di\u011fer \u00f6nemli ikincil sonlan\u0131m noktalar\u0131.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Bu Sayfay\u0131 Takip Edin<\/strong>&nbsp;&gt;&gt;&gt;&nbsp;<a href=\"https:\/\/dmdwarrior.com\/tr\/dmd-therapies\/\" target=\"_blank\" rel=\"noreferrer noopener\">Duchenne i\u00e7in T\u00fcm Klinik Ara\u015ft\u0131rmalar<\/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\/tr\/wp-json\/wp\/v2\/posts\/6196","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/comments?post=6196"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/6196\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media\/6197"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media?parent=6196"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/categories?post=6196"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/tags?post=6196"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}