Start of Phase I study with SDL-M1: First sub­ject dosed

The clin­i­cal trial in which SmartDyeLivery’s nanocar­rier SDL-M1 will be admin­is­tered to humans for the first time has offi­cially begun. The Phase I trial will test the safety and tol­er­a­bil­ity of the intra­venously admin­is­tered nanocar­rier in healthy vol­un­teers. SDL-M1 is a sus­pen­sion of poly­meric nanopar­ti­cles that deliver an active sub­stance specif­i­cally into the meta­bolic cells of the liver.  The aim is to treat the seri­ous and often pro­tracted dis­or­der of bile for­ma­tion. There is cur­rently no treat­ment option for this com­pli­ca­tion in sep­tic patients, for which the mor­tal­ity rate is over 90 %.

The recruit­ment of vol­un­teer men and women already began at the end of Jan­u­ary. The screen­ing tests to select the first suit­able study par­tic­i­pants have been suc­cess­fully com­pleted and SDL-M1 was applied to the first par­tic­i­pant. “We and our part­ners have worked towards this day with great focus and per­se­ver­ance and we are delighted to have reached this impor­tant mile­stone. In addi­tion to the reg­u­la­tory require­ments, the pro­duc­tion of the nanopar­ti­cles accord­ing to the strictest qual­ity cri­te­ria was a par­tic­u­lar chal­lenge that we, together with our part­ners, suc­cess­fully mas­tered,” said Dr. Marc Lehmann, SmartDyeLivery’s Man­ag­ing Director.

The found­ing team with Prof. Dr. Michael Bauer (Uni­ver­sity Hos­pi­tal Jena) and Prof. Dr. Ulrich S. Schu­bert (Friedrich-Schiller-Uni­ver­sity Jena) is delighted that the appli­ca­tion-ori­ented and tech­no­log­i­cal foun­da­tions that were laid are now lead­ing to a prod­uct in clin­i­cal tri­als that could help affected patients in the future.

Smart­Dye­Liv­ery is col­lab­o­rat­ing with the Char­ité Research Organ­i­sa­tion GmbH in Berlin to con­duct the strictly reg­u­lated clin­i­cal trial. This part­ner with many years of expe­ri­ence, par­tic­u­larly in Phase I stud­ies, has already sup­ported Smart­Dye­Liv­ery dur­ing the process of appli­ca­tion for approval and dur­ing the setup of the first-in-human study.

The ran­dom­ized, dou­ble-blind, placebo-con­trolled clin­i­cal trial with SDL-M1 is divided into two parts: In the first part, ascend­ing sin­gle doses will be tested, fol­lowed by mul­ti­ple ascend­ing doses in the sec­ond part. The tran­si­tion from the first to the sec­ond part of the trial will only take place if strict safety cri­te­ria are met. The dos­ing of the test sub­jects is to be com­pleted this year.

The pre­clin­i­cal tox­i­c­ity and safety stud­ies that led to the approval of the Phase I study showed extremely pos­i­tive results. “We assume that the results from the pre­clin­i­cal study can be con­firmed in humans and are con­vinced that the study will pro­ceed as planned,” said Ste­fan Jahn, Senior Invest­ment Man­ager of the bm|t who has been with Smart­Dye­Liv­ery since the very beginning.

About Smart­Dye­Liv­ery: Smart­Dye­Liv­ery GmbH from Jena is devel­op­ing a uni­ver­sal plat­form tech­nol­ogy based on func­tion­alised nanopar­ti­cles that can be used to trans­port active ingre­di­ents or other car­goes to the desired tar­get site. The aim is to pro­vide new ther­a­peu­tic options for dis­eases that were pre­vi­ously untreat­able or dif­fi­cult to treat. The inno­v­a­tive, patent-pro­tected tech­nol­ogy can also be used for diag­nos­tic or ther­a­nos­tic applications.

Fur­ther infor­ma­tion can be found at  www.smartdyelivery.de

About bm|t: bm|t, based in Erfurt, is a sub­sidiary of Thüringer Auf­baubank and the lead­ing address for invest­ments in Thuringia. bm|t cur­rently man­ages twelve funds with a total vol­ume of around EUR 445 mil­lion, which are to be invested in inno­v­a­tive com­pa­nies in almost all sec­tors and in all phases of cor­po­rate devel­op­ment – both in the start-up and growth phases or in com­pany suc­ces­sion situations.

Fur­ther infor­ma­tion can be found at www.bm‑t.de