{"id":4534,"date":"2025-09-22T14:57:32","date_gmt":"2025-09-22T11:57:32","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=4534"},"modified":"2025-09-22T15:27:53","modified_gmt":"2025-09-22T12:27:53","slug":"satellos-submits-ind-to-fda-for-phase-2-sat-3247-clinical-trial-in-duchenne-muscular-dystrophy","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/tr\/satellos-submits-ind-to-fda-for-phase-2-sat-3247-clinical-trial-in-duchenne-muscular-dystrophy\/","title":{"rendered":"Satellos, Duchenne Kas Distrofisi'nde SAT-3247 Faz 2  Klinik Denemesi i\u00e7in FDA'ya Ba\u015fvuruda Bulundu"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Satellos Bioscience, ABD G\u0131da ve \u0130la\u00e7 Dairesi&#039;ne (FDA) Ara\u015ft\u0131rma Ama\u00e7l\u0131 Yeni \u0130la\u00e7 (IND) ba\u015fvurusunda bulundu\u011funu ve Birle\u015fik Krall\u0131k, Avrupa, S\u0131rbistan ve Avustralya&#039;da paralel d\u00fczenleyici ba\u015fvurularda bulunarak, Duchenne kas distrofisi (Duchenne veya DMD) olan ayakta tedavi g\u00f6ren \u00e7ocuklarda SAT-3247&#039;nin Faz 2 klinik \u00e7al\u0131\u015fmas\u0131n\u0131 ba\u015flatt\u0131\u011f\u0131n\u0131 duyurdu.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Planlanan 2. Faz denemesine, FDA onay\u0131n\u0131n ard\u0131ndan ABD&#039;de Duchenne&#039;li \u00e7ocuklar ve \u00fclke sa\u011fl\u0131k otoritelerinin onaylar\u0131n\u0131n ard\u0131ndan k\u00fcresel olarak dahil edilecek.<\/strong> \u00dc\u00e7 ayl\u0131k randomize, plasebo kontroll\u00fc \u00e7al\u0131\u015fma, g\u00fcvenlik ve tolerans\u0131n yan\u0131 s\u0131ra g\u00fc\u00e7, i\u015flev, biyobelirte\u00e7ler ve kas sa\u011fl\u0131\u011f\u0131n\u0131n temel \u00f6l\u00e7\u00fcmlerini de\u011ferlendirecektir. Bu \u00e7al\u0131\u015fma i\u00e7in dokuz ayl\u0131k a\u00e7\u0131k etiketli bir uzatma da planlanmaktad\u0131r.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u00d6ne \u00c7\u0131kan Konular<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>ABD, \u0130ngiltere, Avrupa, S\u0131rbistan ve Avustralya&#039;da d\u00fczenleyici ba\u015fvurular yap\u0131ld\u0131<\/strong><\/li>\n\n\n\n<li>Y\u00fcr\u00fcyebilen \u00e7ocuklarda g\u00fcvenli\u011fi, farmakokineti\u011fi, dozu, kas biyopsilerini ve fonksiyon \u00f6l\u00e7\u00fcmlerini de\u011ferlendirmek i\u00e7in \u00fc\u00e7 ayl\u0131k randomize plasebo kontroll\u00fc \u00e7al\u0131\u015fma<\/li>\n\n\n\n<li><strong>\u00c7al\u0131\u015fmaya ilk hastan\u0131n 2025 y\u0131l\u0131 sonuna kadar dahil edilmesi bekleniyor<\/strong><\/li>\n\n\n\n<li>Avustralya&#039;da Faz 1b \u00e7al\u0131\u015fmas\u0131ndan yeti\u015fkin hastalarla uzun vadeli uzatma \u00e7al\u0131\u015fmas\u0131 onayland\u0131; ek yeti\u015fkin hastalar\u0131n da dahil edilmesi planlan\u0131yor<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Satellos Kurucu Orta\u011f\u0131 ve CEO'su Frank Gleeson, \"ABD ve d\u00fcnya genelinde Faz 2 klinik deneme ba\u015fvurular\u0131m\u0131z\u0131 sunmak, Satellos'un Duchenne'i yeni bir \u015fekilde tedavi etme potansiyelini ilerletmesinde \u00f6nemli bir d\u00f6n\u00fcm noktas\u0131d\u0131r,\" dedi. \"Mevcut tedaviler, Duchenne'deki temel sorunu, yani v\u00fccudun bozulmu\u015f kas onar\u0131m s\u00fcrecini ele alm\u0131yor. SAT-3247 ile amac\u0131m\u0131z, kaslar\u0131 onarma, fonksiyonel sonu\u00e7lar\u0131 iyile\u015ftirme ve hayatlar\u0131 ger\u00e7ekten de\u011fi\u015ftirme potansiyeline sahip bu rejeneratif d\u00f6ng\u00fcy\u00fc yeniden ba\u015flatmak.\"<\/p>\n\n\n\n<figure class=\"wp-block-embed is-type-video is-provider-vimeo wp-block-embed-vimeo\"><div class=\"wp-block-embed__wrapper\">\n<iframe loading=\"lazy\" title=\"Satellos: SAT-3247 Etki Mekanizmas\u0131\" src=\"https:\/\/player.vimeo.com\/video\/1111725853?h=ad68c0e107&amp;dnt=1&amp;app_id=122963\" width=\"696\" height=\"392\" frameborder=\"0\" allow=\"autoplay; fullscreen; picture-in-picture; clipboard-write; encrypted-media; web-share\" referrerpolicy=\"strict-origin-when-cross-origin\"><\/iframe>\n<\/div><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">SAT-3247&#039;nin Klinik Denemeleri<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>SAT-3247, Duchenne&#039;de bozulan bir s\u00fcre\u00e7 olan kaslar\u0131n yenilenme yetene\u011fini v\u00fccudun yeniden canland\u0131rmas\u0131 i\u00e7in tasarlanm\u0131\u015f, oral, k\u00fc\u00e7\u00fck molek\u00fcll\u00fc bir tedavidir.<\/strong> Duchenne&#039;li be\u015f yeti\u015fkinde yak\u0131n zamanda tamamlanan bir Faz 1b \u00e7al\u0131\u015fmas\u0131nda, SAT-3247 g\u00fcvenli ve iyi tolere edilmi\u015f ve Duchenne&#039;li yeti\u015fkinlerde SAT-3247&#039;nin farmakokineti\u011fi sa\u011fl\u0131kl\u0131 g\u00f6n\u00fcll\u00fclerinkiyle \u00f6rt\u00fc\u015fm\u00fc\u015ft\u00fcr. Daha da \u00f6nemlisi, etkililik ara\u015ft\u0131r\u0131lm\u0131\u015f ve 28 g\u00fcn boyunca kavrama g\u00fcc\u00fcnde yakla\u015f\u0131k iki kat\u0131na \u00e7\u0131kma ve kuvvet vital kapasitesinde (akci\u011fer fonksiyonu) 5% iyile\u015fme g\u00f6zlenmi\u015ftir. Satellos, Faz 1b \u00e7al\u0131\u015fmas\u0131na kat\u0131lan bireyler aras\u0131nda uzun vadeli g\u00fcvenlik ve etkinli\u011fi de\u011ferlendirmek \u00fczere Avustralya&#039;da 11 ayl\u0131k bir uzatma \u00e7al\u0131\u015fmas\u0131 ba\u015flatm\u0131\u015ft\u0131r. Bu \u00e7al\u0131\u015fman\u0131n daha da geni\u015fletilmesi planlanmaktad\u0131r. <strong>Devam\u0131n\u0131 oku<\/strong>: <a href=\"https:\/\/dmdwarrior.com\/tr\/satellos-sat-3247-stem-cell-approach-may-restore-muscle-regeneration-in-duchenne-muscular-dystrophy\/\">Satellos SAT-3247 Yakla\u015f\u0131m\u0131<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Satellos Bioscience announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), along with parallel regulatory filings in the United Kingdom, Europe, Serbia and Australia, to initiate a Phase 2 clinical trial of SAT-3247 in ambulatory children with Duchenne muscular dystrophy (Duchenne or DMD). The planned Phase [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":4536,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[137,88,254,251,252,253],"class_list":["post-4534","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-clinical-trial","tag-fda","tag-frank-gleeson","tag-sat-3247","tag-satellos","tag-satellos-bioscience"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/4534","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=4534"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/4534\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media\/4536"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media?parent=4534"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/categories?post=4534"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/tags?post=4534"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}