{"id":5302,"date":"2025-12-09T17:14:24","date_gmt":"2025-12-09T14:14:24","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=5302"},"modified":"2025-12-09T17:25:38","modified_gmt":"2025-12-09T14:25:38","slug":"satellos-receives-fda-and-international-clearance-to-commence-pediatric-phase-2-testing-of-sat-3247-for-duchenne-muscular-dystrophy","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/zh\/satellos-receives-fda-and-international-clearance-to-commence-pediatric-phase-2-testing-of-sat-3247-for-duchenne-muscular-dystrophy\/","title":{"rendered":"Satellos \u83b7\u5f97 FDA \u548c\u56fd\u9645\u6279\u51c6\uff0c\u5f00\u59cb\u5bf9 SAT-3247 \u8fdb\u884c\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\u7684\u513f\u79d1 II \u671f\u8bd5\u9a8c"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Satellos\u516c\u53f8\u5ba3\u5e03\uff0c\u5176\u7814\u53d1\u7684\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\uff08IND\uff09\u5df2\u83b7\u5f97\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\uff08FDA\uff09\u53ca\u5176\u4ed6\u56fd\u9645\u76d1\u7ba1\u673a\u6784\u7684\u6279\u51c6\uff0c\u5c06\u542f\u52a8\u4e00\u9879\u4e3a\u671f\u4e09\u4e2a\u6708\u7684\u968f\u673a\u3001\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u7684II\u671f\u6982\u5ff5\u9a8c\u8bc1\u8bd5\u9a8c\u2014\u2014SAT-3247-CL-201\u3002\u8be5\u7814\u7a76\u5c06\u8bc4\u4f30SAT-3247\u572851\u540d\u786e\u8bca\u4e3a\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\uff08Duchenne\u6216DMD\uff09\u7684\u53ef\u72ec\u7acb\u884c\u8d70\u513f\u7ae5\u4e2d\u7684\u7597\u6548\u3002 <a href=\"https:\/\/dmdwarrior.com\/zh\/potential-of-sat-3247-to-restore-muscle-regeneration-in-duchenne-published-in-nature\/\" target=\"_blank\" rel=\"noreferrer noopener\">SAT-3247 \u5177\u6709\u6062\u590d\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\u60a3\u8005\u808c\u8089\u518d\u751f\u7684\u6f5c\u529b\uff0c\u76f8\u5173\u7814\u7a76\u53d1\u8868\u4e8e\u300a\u81ea\u7136\u300b\u6742\u5fd7\u3002<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">SAT-3247 \u7684\u4e34\u5e8a\u8bd5\u9a8c<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u4e00\u9879\u5b89\u6170\u5242\u5bf9\u7167\u7684 II \u671f\u7814\u7a76\u5c06\u8bc4\u4f30 SAT-3247 \u6cbb\u7597\u4e09\u4e2a\u6708\u5bf9\u53ef\u72ec\u7acb\u884c\u8d70\u7684\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\u60a3\u513f\u7684\u7597\u6548\u3002<\/li>\n\n\n\n<li>\u7814\u7a76\u7ec8\u70b9\u5305\u62ec\u5b89\u5168\u6027\u548c\u8010\u53d7\u6027\u3001\u5bf9\u808c\u8089\u529b\u91cf\u548c\u529f\u80fd\u7684\u5f71\u54cd\uff0c\u4ee5\u53ca\u5bf9\u808c\u8089\u8d28\u91cf\u548c\u518d\u751f\u80fd\u529b\u7684\u5f71\u54cd\u3002<\/li>\n\n\n\n<li>\u9884\u8ba1\u9996\u4f8b\u7814\u7a76\u53c2\u4e0e\u8005\u5c06\u4e8e2025\u5e74\u5e95\u5165\u7ec4\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u201c\u6211\u4eec\u5f88\u9ad8\u5174\u83b7\u5f97\u7f8e\u56fd\u548c\u5168\u7403\u6279\u51c6\uff0c\u542f\u52a8\u6211\u4eec\u540d\u4e3aBASECAMP\u7684SAT-3247\u7684II\u671f\u513f\u79d1\u7814\u7a76\u3002\u8fd9\u4e00\u91cd\u8981\u91cc\u7a0b\u7891\u4f7fSatellos\u80fd\u591f\u8bc1\u660eSAT-3247\u6709\u6f5c\u529b\u5b89\u5168\u5730\u6062\u590d\u60a3\u6709\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\u7684\u513f\u7ae5\u7684\u8eab\u4f53\u4fee\u590d\u548c\u518d\u751f\u808c\u8089\u7684\u80fd\u529b\uff0c\u5e76\u6539\u53d8\u75be\u75c5\u7684\u8fdb\u5c55\uff0c\u201dSatellos\u8054\u5408\u521b\u59cb\u4eba\u517c\u9996\u5e2d\u6267\u884c\u5b98Frank Gleeson\u8868\u793a\u3002. <strong>\u201c\u6211\u4eec\u5728\u6210\u4eba 1b \u671f\u7814\u7a76\u4e2d\u83b7\u5f97\u4e86\u4ee4\u4eba\u9f13\u821e\u7684\u529f\u80fd\u6570\u636e\uff0c\u6211\u4eec\u6709\u4fe1\u5fc3 SAT-3247 \u80fd\u5bf9\u60a3\u6709\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\u7684\u513f\u7ae5\u4ea7\u751f\u5f71\u54cd\uff0c\u6211\u4eec\u5f88\u9ad8\u5174\u5373\u5c06\u5f00\u59cb\u8bd5\u9a8c\u7684\u62db\u52df\u5de5\u4f5c\u3002\u201d<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u9664\u4e86\u83b7\u5f97 FDA \u7684\u6279\u51c6\u5916\uff0c\u82f1\u56fd\u836f\u54c1\u548c\u4fdd\u5065\u4ea7\u54c1\u76d1\u7ba1\u5c40 (MHRA) \u8fd8\u6279\u51c6\u4e86\u8be5\u516c\u53f8\u7684\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7 (CTA)\uff1b\u6fb3\u5927\u5229\u4e9a\u4eba\u7c7b\u7814\u7a76\u4f26\u7406\u59d4\u5458\u4f1a (HREC) \u63a5\u53d7\u4e86\u6cbb\u7597\u7528\u54c1\u7ba1\u7406\u5c40 (TGA) \u7684\u4e34\u5e8a\u8bd5\u9a8c\u901a\u77e5 (CTN) \u65b9\u6848\uff0c\u4ee5\u83b7\u5f97\u76d1\u7ba1\u6388\u6743\uff1b\u585e\u5c14\u7ef4\u4e9a\u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u7ba1\u7406\u5c40 (ALIMS) \u4e5f\u6279\u51c6\u4e86\u8be5\u516c\u53f8\u7684 CTA\u3002. <strong>\u8be5\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u4ecd\u5728\u6b27\u76df\u548c\u52a0\u62ff\u5927\u6309\u7167\u65e2\u5b9a\u65f6\u95f4\u8868\u548c\u7a0b\u5e8f\u8fdb\u884c\u5ba1\u67e5\u3002.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>SAT-3247 \u662f\u4e00\u79cd\u53e3\u670d\u5c0f\u5206\u5b50\u7597\u6cd5\uff0c\u65e8\u5728\u6062\u590d\u4eba\u4f53\u518d\u751f\u808c\u8089\u7684\u80fd\u529b\uff0c\u800c\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\u60a3\u8005\u7684\u808c\u8089\u518d\u751f\u8fc7\u7a0b\u53d7\u5230\u635f\u5bb3\u3002<\/strong> \u5728\u4e00\u9879\u9488\u5bf9\u6210\u5e74\u4eba\u7684 1a\/b \u671f\u7814\u7a76\u4e2d\uff0cSAT-3247 \u5b89\u5168\u6027\u826f\u597d\uff0c\u8010\u53d7\u6027\u4f73\uff0c\u4e14\u5177\u6709\u7406\u60f3\u7684\u836f\u4ee3\u52a8\u529b\u5b66 (PK) \u7279\u5f81\u3002\u8be5\u7814\u7a76\u7684 B \u90e8\u5206\u7eb3\u5165\u4e86\u63a5\u53d7 SAT-3247 \u6cbb\u7597 28 \u5929\u7684\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\u6210\u5e74\u60a3\u8005\uff0c\u7ed3\u679c\u663e\u793a\uff0c\u4f18\u52bf\u624b\u6700\u5927\u63e1\u529b\u5e73\u5747\u63d0\u9ad8 118.61 \u500d\uff0c\u975e\u4f18\u52bf\u624b\u6700\u5927\u63e1\u529b\u5e73\u5747\u63d0\u9ad8 97.91 \u500d\uff0c\u63e1\u529b\u5927\u7ea6\u4ece\u7ea6 2 \u516c\u65a4\u589e\u52a0\u5230\u7ea6 4 \u516c\u65a4\uff0c\u76f8\u5f53\u4e8e\u7ffb\u4e86\u4e00\u756a\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>BASECAMP \u662f\u4e00\u9879\u4e3a\u671f\u4e09\u4e2a\u6708\u7684\u5168\u7403\u6027\u3001\u968f\u673a\u3001\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u7684\u6982\u5ff5\u9a8c\u8bc1\u7814\u7a76\uff0c\u7eb3\u5165 51 \u540d\u53ef\u72ec\u7acb\u884c\u8d70\u7684\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\u60a3\u513f\u3002\u4e3b\u8981\u7ec8\u70b9\u5c06\u8bc4\u4f30 SAT-3247 \u7684\u5b89\u5168\u6027\u548c\u8010\u53d7\u6027\u53ca\u5176\u5bf9\u808c\u8089\u529b\u91cf\u7684\u5f71\u54cd\u3002.<\/strong> \u6b21\u8981\u7ec8\u70b9\u5c06\u8bc4\u4f30 SAT-3247 \u5bf9\u808c\u8089\u8d28\u91cf\u3001\u529f\u80fd\u548c\u518d\u751f\u7684\u5f71\u54cd\u3002\u9884\u8ba1\u9996\u4f8b\u53d7\u8bd5\u8005\u5c06\u4e8e 2025 \u5e74\u5e95\u5165\u7ec4\u3002Satellos \u9884\u8ba1\u5c06\u4e8e 2026 \u5e74\u7b2c\u4e8c\u5b63\u5ea6\u516c\u5e03 BASECAMP \u7814\u7a76\u7684\u521d\u6b65\u4e2d\u671f\u6570\u636e\uff0c\u5e76\u4e8e 2026 \u5e74\u7b2c\u4e00\u5b63\u5ea6\u516c\u5e03 LT-001 \u7814\u7a76\uff08\u9488\u5bf9 DMD \u6210\u5e74\u60a3\u8005\uff09\u7684\u6570\u636e\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u5173\u4e8e SAT-3247<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">SAT-3247 \u662f\u4e00\u79cd\u4e13\u6709\u7684\u53e3\u670d\u5c0f\u5206\u5b50\u836f\u7269\uff0c\u7531 Satellos \u516c\u53f8\u5f00\u53d1\uff0c\u65e8\u5728\u4e3a\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7 (DMD) \u53ca\u5176\u4ed6\u9000\u884c\u6027\u6216\u635f\u4f24\u6027\u75be\u75c5\u4e2d\u53d7\u635f\u7684\u9aa8\u9abc\u808c\u518d\u751f\u63d0\u4f9b\u4e00\u79cd\u65b0\u578b\u7597\u6cd5\u3002Satellos \u516c\u53f8\u6b63\u81f4\u529b\u4e8e\u63a8\u8fdb SAT-3247 \u7684\u7814\u53d1\uff0c\u4f7f\u5176\u6210\u4e3a\u4e00\u79cd\u6f5c\u5728\u7684 DMD \u6cbb\u7597\u836f\u7269\uff0c\u5176\u7597\u6548\u72ec\u7acb\u4e8e\u808c\u8425\u517b\u4e0d\u826f\u86cb\u767d\uff0c\u4e14\u4e0d\u53d7\u5916\u663e\u5b50\u7a81\u53d8\u72b6\u6001\u7684\u5f71\u54cd\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u5173\u6ce8\u6b64\u9875\u9762<\/strong>&nbsp;&gt;&gt;&gt;&nbsp;<a href=\"https:\/\/dmdwarrior.com\/zh\/dmd-therapies\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u6240\u6709\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\u7684\u4e34\u5e8a\u8bd5\u9a8c<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Satellos reported that it has obtained Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) and additional international regulators to initiate SAT-3247-CL-201\u2014a three-month, randomized, double-blind, placebo-controlled Phase 2 proof-of-concept trial. The study will evaluate SAT-3247 in 51 ambulatory children diagnosed with Duchenne muscular dystrophy (Duchenne or DMD). >> Potential of SAT-3247 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":5304,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[88,254,251,252,253,259],"class_list":["post-5302","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-fda","tag-frank-gleeson","tag-sat-3247","tag-satellos","tag-satellos-bioscience","tag-stem-cell-therapy"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts\/5302","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=5302"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts\/5302\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/media\/5304"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/media?parent=5302"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/categories?post=5302"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/tags?post=5302"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}