{"id":3455,"date":"2025-03-31T13:16:29","date_gmt":"2025-03-31T10:16:29","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=3455"},"modified":"2025-11-03T20:22:57","modified_gmt":"2025-11-03T17:22:57","slug":"keros-therapeutics-announces-initial-topline-results-from-the-phase-1-clinical-trial-of-ker-065-in-healthy-volunteers","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/tr\/keros-therapeutics-announces-initial-topline-results-from-the-phase-1-clinical-trial-of-ker-065-in-healthy-volunteers\/","title":{"rendered":"Keros Therapeutics, Sa\u011fl\u0131kl\u0131 G\u00f6n\u00fcll\u00fclerde KER-065&#039;nin 1. Faz Klinik Denemesinden \u0130lk \u00d6nemli Sonu\u00e7lar\u0131 Duyurdu"},"content":{"rendered":"<p class=\"wp-block-paragraph\">D\u00f6n\u00fc\u015ft\u00fcr\u00fcc\u00fc b\u00fcy\u00fcme fakt\u00f6r\u00fc-beta (&quot;TGF-\u00df&quot;) protein ailesinin i\u015flevsiz sinyalizasyonuyla ba\u011flant\u0131l\u0131 bozukluklar\u0131 olan \u00e7ok \u00e7e\u015fitli hastalar\u0131 tedavi etmek i\u00e7in yeni terap\u00f6tikler geli\u015ftirmeye ve ticarile\u015ftirmeye odaklanan klinik a\u015famadaki bir biyofarmas\u00f6tik \u015firket olan Keros Therapeutics, bug\u00fcn sa\u011fl\u0131kl\u0131 g\u00f6n\u00fcll\u00fclerde KER-065&#039;nin Faz 1 klinik \u00e7al\u0131\u015fmas\u0131ndan ilk \u00f6nemli sonu\u00e7lar\u0131 duyurdu. Bu devam eden \u00e7al\u0131\u015fman\u0131n \u00f6nemli sonu\u00e7lar\u0131, \u00e7oklu artan doz (&quot;MAD&quot;) tedavi d\u00f6nemi boyunca (85. G\u00fcn) elde edildi.<\/p>\n\n\n\n<div class=\"wp-block-rank-math-toc-block\" id=\"rank-math-toc\"><h2>\u0130\u00e7indekiler<\/h2><nav><ul><li><a href=\"#key-findings-from-ker-065-include\">KER-065&#039;den \u00d6nemli Bulgular<\/a><\/li><li><a href=\"#about-the-ker-065-phase-1-clinical-trial\">KER-065 Faz 1 Klinik \u00c7al\u0131\u015fmas\u0131 Hakk\u0131nda<\/a><\/li><li><a href=\"#about-ker-065\">KER-065 Hakk\u0131nda<\/a><\/li><\/ul><\/nav><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"key-findings-from-ker-065-include\">KER-065&#039;den \u00d6nemli Bulgular<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>KER-065 genel olarak iyi tolere edildi ve bug\u00fcne kadar \u00f6nemli bir g\u00fcvenlik sinyali g\u00f6zlemlenmedi\n<ul class=\"wp-block-list\">\n<li>Ciddi bir olumsuz olay veya doz s\u0131n\u0131rlay\u0131c\u0131 toksisite bildirilmedi<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>\u0130lgi duyulan dokularda aktivin inhibisyonuna dair kan\u0131t, KER-065&#039;nin ortaya \u00e7\u0131kard\u0131\u011f\u0131 gibi:\n<ul class=\"wp-block-list\">\n<li>Kemik olu\u015fumunun bir biyobelirteci olan kemi\u011fe \u00f6zg\u00fc alkalin fosfatta (BSAP) art\u0131\u015flar ve kemik rezorpsiyonunun bir biyobelirteci olan C-Terminal Telopeptid&#039;de (CTX) azalmalar<\/li>\n\n\n\n<li>Ya\u011f mobilizasyonunun biyobelirteci olan adiponektinde art\u0131\u015flar ve ya\u011f k\u00fctlesinin biyobelirteci olan leptinde azalmalar<\/li>\n\n\n\n<li>Kemik mineral yo\u011funlu\u011funda ve kas k\u00fctlesinde art\u0131\u015flar ve ya\u011f k\u00fctlesinde azalmalarla g\u00f6sterildi\u011fi gibi v\u00fccut kompozisyonunda meydana gelen de\u011fi\u015fiklikler, bunlar\u0131n t\u00fcm\u00fc aktivin inhibisyonuyla tutarl\u0131yd\u0131<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"about-the-ker-065-phase-1-clinical-trial\">KER-065 Faz 1 Klinik \u00c7al\u0131\u015fmas\u0131 Hakk\u0131nda<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">KER-065 Faz 1 klinik \u00e7al\u0131\u015fmas\u0131, sa\u011fl\u0131kl\u0131 g\u00f6n\u00fcll\u00fclerde randomize, \u00e7ift k\u00f6r, plasebo kontroll\u00fc, iki par\u00e7al\u0131 doz art\u0131rma (tek artan doz ve MAD) \u00e7al\u0131\u015fmas\u0131d\u0131r. Bu \u00e7al\u0131\u015fman\u0131n birincil hedefleri, KER-065&#039;nin g\u00fcvenli\u011fini, tolere edilebilirli\u011fini ve farmakokineti\u011fini de\u011ferlendirmekti. Ke\u015fifsel son noktalar, kemik, ya\u011f dokusu, kas, kalp dokusu ve fibroz \u00fczerindeki farmakodinamik etkinin de\u011ferlendirmelerini i\u00e7erir. (<a href=\"https:\/\/ir.kerostx.com\/news-releases\/news-release-details\/keros-therapeutics-announces-initial-topline-results-phase-1\" target=\"_blank\" rel=\"noreferrer noopener\">Devam\u0131n\u0131 oku<\/a>)<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"about-ker-065\">KER-065 Hakk\u0131nda<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">KER-065, aktivin resept\u00f6r\u00fc tip IIA ve aktivin resept\u00f6r\u00fc tip IIB&#039;den t\u00fcretilen ve Fc alan\u0131 olarak bilinen insan antikorunun bir k\u0131sm\u0131na kayna\u015ft\u0131r\u0131lm\u0131\u015f modifiye edilmi\u015f bir ligand ba\u011flay\u0131c\u0131 alandan olu\u015fan yeni bir ligand tuza\u011f\u0131d\u0131r. KER-065, bir ligand tuza\u011f\u0131 olarak hareket etmek ve iskelet kas\u0131 rejenerasyonunu art\u0131rmak, kas boyutunu ve g\u00fcc\u00fcn\u00fc art\u0131rmak, v\u00fccut ya\u011f\u0131n\u0131 azaltmak, iskelet kas\u0131n\u0131n fibrozunu azaltmak ve kemik g\u00fcc\u00fcn\u00fc art\u0131rmak i\u00e7in aktivin resept\u00f6rleri arac\u0131l\u0131\u011f\u0131yla sinyal g\u00f6nderen iki ligand olan miyostatin ve aktivin A&#039;n\u0131n biyolojik etkilerini engellemek \u00fczere tasarlanm\u0131\u015ft\u0131r. KER-065&#039;yi, ba\u015flang\u0131\u00e7ta DMD&#039;ye odaklanarak n\u00f6rom\u00fcsk\u00fcler hastal\u0131klar\u0131n tedavisi i\u00e7in geli\u015ftiriyoruz.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Devam\u0131n\u0131 oku<\/strong>:\u00a0<a href=\"https:\/\/dmdwarrior.com\/tr\/dmd-therapies\/\" target=\"_blank\" rel=\"noreferrer noopener\">Duchenne \u0130\u00e7in Klinik Ara\u015ft\u0131rmalar (T\u00fcm Ara\u015ft\u0131rmalar\u0131n Listesi)<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Keros Therapeutics, a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (\u201cTGF-\u00df\u201d) family of proteins, today announced initial topline results from the Phase 1 clinical trial of KER-065 in healthy volunteers. Topline results [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":3457,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[27],"tags":[137,337,336],"class_list":["post-3455","post","type-post","status-publish","format-standard","has-post-thumbnail","category-research","tag-clinical-trial","tag-ker-065","tag-keros-therapeutics"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/3455","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=3455"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/3455\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media\/3457"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media?parent=3455"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/categories?post=3455"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/tags?post=3455"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}