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

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).

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.

It has a two-part, placebo-controlled, double-blind, randomised, dose-escalation (single ascending dose) design.

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.

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

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.

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

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

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

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.

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

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