{"id":16777,"date":"2025-04-03T13:30:41","date_gmt":"2025-04-03T11:30:41","guid":{"rendered":"https:\/\/www.bm-t.de\/?p=16777"},"modified":"2025-04-04T08:17:51","modified_gmt":"2025-04-04T06:17:51","slug":"smartdyelivery-starts-first-clinical-study-with-polymeric-nanocarriers","status":"publish","type":"post","link":"https:\/\/www.bm-t.de\/en\/2025-en\/smartdyelivery-starts-first-clinical-study-with-polymeric-nanocarriers\/","title":{"rendered":"SmartDyeLivery starts first clinical study with polymeric nanocarriers"},"content":{"rendered":"

Start of Phase I study with SDL-M1: First sub\u00adject dosed<\/strong><\/p>\n

The clin\u00adi\u00adcal trial in which SmartDyeLivery\u2019s nanocar\u00adrier SDL-M1 will be admin\u00adis\u00adtered to humans for the first time has offi\u00adcially begun. The Phase I trial will test the safety and tol\u00ader\u00ada\u00adbil\u00adity of the intra\u00advenously admin\u00adis\u00adtered nanocar\u00adrier in healthy vol\u00adun\u00adteers. SDL-M1 is a sus\u00adpen\u00adsion of poly\u00admeric nanopar\u00adti\u00adcles that deliver an active sub\u00adstance specif\u00adi\u00adcally into the meta\u00adbolic cells of the liver.  The aim is to treat the seri\u00adous and often pro\u00adtracted dis\u00ador\u00adder of bile for\u00adma\u00adtion. There is cur\u00adrently no treat\u00adment option for this com\u00adpli\u00adca\u00adtion in sep\u00adtic patients, for which the mor\u00adtal\u00adity rate is over 90 %.<\/p>\n

The recruit\u00adment of vol\u00adun\u00adteer men and women already began at the end of Jan\u00adu\u00adary. The screen\u00ading tests to select the first suit\u00adable study par\u00adtic\u00adi\u00adpants have been suc\u00adcess\u00adfully com\u00adpleted and SDL-M1 was applied to the first par\u00adtic\u00adi\u00adpant. \u201cWe and our part\u00adners have worked towards this day with great focus and per\u00adse\u00adver\u00adance and we are delighted to have reached this impor\u00adtant mile\u00adstone. In addi\u00adtion to the reg\u00adu\u00adla\u00adtory require\u00adments, the pro\u00adduc\u00adtion of the nanopar\u00adti\u00adcles accord\u00ading to the strictest qual\u00adity cri\u00adte\u00adria was a par\u00adtic\u00adu\u00adlar chal\u00adlenge that we, together with our part\u00adners, suc\u00adcess\u00adfully mas\u00adtered,\u201d said Dr. Marc Lehmann, SmartDyeLivery\u2019s Man\u00adag\u00ading Director.<\/p>\n

The found\u00ading team with Prof. Dr. Michael Bauer (Uni\u00adver\u00adsity Hos\u00adpi\u00adtal Jena) and Prof. Dr. Ulrich S. Schu\u00adbert (Friedrich-Schiller-Uni\u00adver\u00adsity Jena) is delighted that the appli\u00adca\u00adtion-ori\u00adented and tech\u00adno\u00adlog\u00adi\u00adcal foun\u00adda\u00adtions that were laid are now lead\u00ading to a prod\u00aduct in clin\u00adi\u00adcal tri\u00adals that could help affected patients in the future.<\/p>\n

Smart\u00adDye\u00adLiv\u00adery is col\u00adlab\u00ado\u00adrat\u00ading with the Char\u00adit\u00e9 Research Organ\u00adi\u00adsa\u00adtion GmbH in Berlin to con\u00adduct the strictly reg\u00adu\u00adlated clin\u00adi\u00adcal trial. This part\u00adner with many years of expe\u00adri\u00adence, par\u00adtic\u00adu\u00adlarly in Phase I stud\u00adies, has already sup\u00adported Smart\u00adDye\u00adLiv\u00adery dur\u00ading the process of appli\u00adca\u00adtion for approval and dur\u00ading the setup of the first-in-human study.<\/p>\n

The ran\u00addom\u00adized, dou\u00adble-blind, placebo-con\u00adtrolled clin\u00adi\u00adcal trial with SDL-M1 is divided into two parts: In the first part, ascend\u00ading sin\u00adgle doses will be tested, fol\u00adlowed by mul\u00adti\u00adple ascend\u00ading doses in the sec\u00adond part. The tran\u00adsi\u00adtion from the first to the sec\u00adond part of the trial will only take place if strict safety cri\u00adte\u00adria are met. The dos\u00ading of the test sub\u00adjects is to be com\u00adpleted this year.<\/p>\n

The pre\u00adclin\u00adi\u00adcal tox\u00adi\u00adc\u00adity and safety stud\u00adies that led to the approval of the Phase I study showed extremely pos\u00adi\u00adtive results. \u201cWe assume that the results from the pre\u00adclin\u00adi\u00adcal study can be con\u00adfirmed in humans and are con\u00advinced that the study will pro\u00adceed as planned,\u201d said Ste\u00adfan Jahn, Senior Invest\u00adment Man\u00adager of the bm|t who has been with Smart\u00adDye\u00adLiv\u00adery since the very beginning.<\/p>\n

 <\/p>\n

About Smart\u00adDye\u00adLiv\u00adery: <\/strong>Smart\u00adDye\u00adLiv\u00adery GmbH from Jena is devel\u00adop\u00ading a uni\u00adver\u00adsal plat\u00adform tech\u00adnol\u00adogy based on func\u00adtion\u00adalised nanopar\u00adti\u00adcles that can be used to trans\u00adport active ingre\u00addi\u00adents or other car\u00adgoes to the desired tar\u00adget site. The aim is to pro\u00advide new ther\u00ada\u00adpeu\u00adtic options for dis\u00adeases that were pre\u00advi\u00adously untreat\u00adable or dif\u00adfi\u00adcult to treat. The inno\u00adv\u00ada\u00adtive, patent-pro\u00adtected tech\u00adnol\u00adogy can also be used for diag\u00adnos\u00adtic or ther\u00ada\u00adnos\u00adtic applications.<\/p>\n

Fur\u00adther infor\u00adma\u00adtion can be found at  www.smartdyelivery.de<\/a><\/p>\n

 <\/strong><\/p>\n

About bm|t: <\/strong>bm|t, based in Erfurt, is a sub\u00adsidiary of Th\u00fcringer Auf\u00adbaubank and the lead\u00ading address for invest\u00adments in Thuringia. bm|t cur\u00adrently man\u00adages twelve funds with a total vol\u00adume of around EUR 445 mil\u00adlion, which are to be invested in inno\u00adv\u00ada\u00adtive com\u00adpa\u00adnies in almost all sec\u00adtors and in all phases of cor\u00adpo\u00adrate devel\u00adop\u00adment \u2013 both in the start-up and growth phases or in com\u00adpany suc\u00adces\u00adsion situations.<\/p>\n

Fur\u00adther infor\u00adma\u00adtion can be found at www.bm\u2011t.de<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

The clin\u00adi\u00adcal trial in which SmartDyeLivery\u2019s nanocar\u00adrier SDL-M1 will be admin\u00adis\u00adtered to humans for the first time has offi\u00adcially begun.<\/p>\n","protected":false},"author":2,"featured_media":13094,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"wp_typography_post_enhancements_disabled":false,"footnotes":""},"categories":[262],"tags":[176,177,210,159,171],"class_list":["post-16777","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-2025-en","tag-bm-t-en","tag-bmt-en","tag-investeepartner","tag-investment-en","tag-thuringia"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/posts\/16777","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/comments?post=16777"}],"version-history":[{"count":1,"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/posts\/16777\/revisions"}],"predecessor-version":[{"id":16858,"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/posts\/16777\/revisions\/16858"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/media\/13094"}],"wp:attachment":[{"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/media?parent=16777"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/categories?post=16777"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/tags?post=16777"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}