{"id":2999,"date":"2025-02-24T15:54:13","date_gmt":"2025-02-24T12:54:13","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=2999"},"modified":"2025-03-07T12:56:14","modified_gmt":"2025-03-07T09:56:14","slug":"entrada-therapeutics-receives-fda-approval-to-begin-clinical-trial-of-entr-601-44-exon-skipping-treatment","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/zh\/entrada-therapeutics-receives-fda-approval-to-begin-clinical-trial-of-entr-601-44-exon-skipping-treatment\/","title":{"rendered":"Entrada Therapeutics \u83b7\u5f97 FDA \u6279\u51c6\uff0c\u5f00\u59cb ENTR-601-44 \u5916\u663e\u5b50\u8df3\u8dc3\u6cbb\u7597\u4e34\u5e8a\u8bd5\u9a8c"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Entrada Therapeutics, announced that the United States Food and Drug Administration (FDA) has lifted the clinical hold on ENTR-601-44 and provided authorization to initiate ELEVATE-44-102, a Phase 1b multiple ascending dose (MAD) clinical study of ENTR-601-44 for the potential treatment of Duchenne muscular dystrophy (DMD) in adult patients with a confirmed mutation in the DMD gene amenable to exon 44 skipping. [Read More: <a href=\"https:\/\/dmdwarrior.com\/upcoming-exon-44-skipping-therapies-for-dmd\/\" target=\"_blank\" rel=\"noreferrer noopener\">Upcoming Exon 44 Skipping Therapies<\/a>]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The global ELEVATE-44 program, which includes the ELEVATE-44-102 study in the U.S. and ELEVATE-44-201 outside of the U.S., will cover a broad population of patients with DMD and support evaluation of ENTR-601-44 in patients with both early and advanced disease. [Read More:\u00a0<a href=\"https:\/\/dmdwarrior.com\/what-is-exon-skipping-and-how-does-it-work\/\" target=\"_blank\" rel=\"noreferrer noopener\">What is exon skipping?<\/a>]<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Entrada Therapeutics Announces FDA Removal of Clinical Hold on ENTR-601-44<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Receives FDA authorization to initiate ELEVATE-44-102, a Phase 1b multiple ascending dose clinical study of ENTR-601-44 in adults living with Duchenne muscular dystrophy.<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Follows recently received Medicines and Healthcare Products Regulatory Agency authorization in the United Kingdom for ELEVATE-44-201.<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Expands global ELEVATE-44 clinical program to include pediatric, adult, ambulatory and non-ambulatory patients with Duchenne muscular dystrophy.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">The Company plans to initiate study enrollment in the first half of 2026, which would enable a seamless transition into an OLE.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Learn More:<\/strong>\u00a0<a href=\"https:\/\/dmdwarrior.com\/new-gene-therapies-for-duchenne-muscular-dystrophy\/\" target=\"_blank\" rel=\"noreferrer noopener\">Potential Upcoming New Gene Therapies for Duchenne Muscular Dystrophy<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Entrada Therapeutics, announced that the United States Food and Drug Administration (FDA) has lifted the clinical hold on ENTR-601-44 and provided authorization to initiate ELEVATE-44-102, a Phase 1b multiple ascending dose (MAD) clinical study of ENTR-601-44 for the potential treatment of Duchenne muscular dystrophy (DMD) in adult patients with a confirmed mutation in the DMD [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":3002,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[265,233,234,141,127,246,77],"class_list":["post-2999","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-entr-601-44","tag-entrada","tag-entrada-therapeutics","tag-exon-44","tag-exon-44-skipping","tag-exon-44-skipping-therapies","tag-exon-skipping"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts\/2999","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/comments?post=2999"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts\/2999\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/media\/3002"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/media?parent=2999"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/categories?post=2999"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/tags?post=2999"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}