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                                    <figcaption>LBL-047 is designed to target both innate and adaptive immune systems through two validated pathways associated with autoimmune disease. Credit: Sai Thaw Kyar/Shutterstock.com.</figcaption>
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<p>Leads Biolabs and Dianthus Therapeutics (DNTH) have initiated a Phase I clinical trial investigating LBL-047 in healthy volunteers and patients with systemic lupus erythematosus (SLE).</p>



<p>The trial aims to assess the pharmacokinetics/pharmacodynamics (PK/PD), safety, and tolerability of LBL-047, a bifunctional fusion protein targeting blood dendritic cell antigen 2 (BDCA2) and transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) ectodomain.</p>



<p>It has a two-part, placebo-controlled, double-blind, randomised, dose-escalation (single ascending dose) design.</p><div>
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<p>Part A will enrol healthy volunteers, led by professor Meng Xianmin at Shanghai Public Health Clinical Centre. Part B will enrol SLE patients, led by professors Ye Shuang and Chen Sheng at Renji Hospital, Shanghai Jiaotong University School of Medicine.</p>



<p>LBL-047 is designed to target both innate and adaptive immune systems through two validated pathways associated with autoimmune disease.</p>



<p>The approach seeks to address multiple autoimmune indications and offer improved outcomes. LBL-047 is intended as a first-line biologic with patient-friendly subcutaneous self-administration and dosing every four weeks or less frequently.</p>



<p>Leads Biolabs and DNTH formed an exclusive global partnership on 16 October 2025, with a total potential deal value up to $1bn.</p>



<p>As part of the agreement, DNTH obtained exclusive global rights, excluding Greater China, to develop, research, commercialise, and manufacture LBL-047.</p>



<p>The therapy is referred to as DNTH212 outside Greater China. DNTH plans to update on prioritised indications in the first half of 2026.</p>



<p>Leads Biolabs chief medical officer Dr Charles Cai said: “We are pleased to announce the successful dosing of the first subject in our Phase I trial of LBL-047. By simultaneously targeting multiple pathways, LBL-047 is designed to address the limitations of single-target therapies.</p>



<p>“We look forward to advancing this programme in collaboration with Dianthus Therapeutics to deliver potentially transformative options for patients worldwide.”</p>
                        
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DNTH

<p>Leads Biolabs and Dianthus Therapeutics (DNTH) have initiated a Phase I clinical trial for LBL-047 in healthy volunteers and patients with systemic lupus erythematosus (SLE). The trial will assess the pharmacokinetics, safety, and tolerability of LBL-047, a bifunctional fusion protein targeting BDCA2 and TACI. The trial has a two-part, placebo-controlled, double-blind, randomised, dose-escalation design. Leads Biolabs and DNTH formed an exclusive global partnership in 2025, with DNTH obtaining global rights, excluding Greater China, to develop and commercialise LBL-047, known as DNTH212 outside Greater China.</p>

Leads Biolabs and DNTH initiate trial of LBL-047 in SLE