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Leads Biolabs And Dianthus Therapeutics Announce Initiation of Phase 1 Trial Of LBL-047 (DNTH212) In Healthy Volunteers and Patients With Systemic Lupus Erythematosus (SLE)
LBL-047 (DNTH212) is a bifunctional fusion protein targeting plasmacytoid dendritic cell (pDC) BDCA2 to reduce Type 1 interferon production, while
About this update from Dianthus Therapeutics, Inc.
[{"type":"text","content":"LBL-047 (DNTH212) is a bifunctional fusion protein targeting plasmacytoid dendritic cell (pDC) BDCA2 to reduce Type 1 interferon production, while simultaneously inhibiting BAFF/APRIL to suppress B cell function Top-line results in healthy volunteers anticipated in 2H’26 Dianthus to provide update on indication prioritization in 1H’26 LBL-047 (DNTH212) has the potential to be a first-line biologic in multiple autoimmune disorders with patient-friendly S.C. self-administration and Q4W or less frequent dosing NANJING, China and NEW YORK and WALTHAM, Mass., Dec. 23, 2025 (GLOBE NEWSWIRE) -- Nanjing Leads Biolabs Co., Ltd. (“Leads Biolabs”) (9887.HK), a clinical-stage biotechnology company focused on developing innovative therapies in oncology, autoimmune, and other severe diseases, and Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to developing next-generation therapies to transform the treatment of severe autoimmune diseases, today announced the first subject has been successfully dosed in the Phase 1 clinical trial of LBL-047 (DNTH212), a potential first- and best-in-class anti-BDCA2/TACI bifunctional fusion protein developed by Leads Biolabs. This two-part, double-blind, randomized, placebo-controlled, dose-escalation (single ascending dose) Phase 1 trial is designed to evaluate the safety, tolerability and PK/PD of LBL-047 (DNTH212) in healthy volunteers (Part A) and patients with systemic lupus erythematosus (Part B). The healthy volunteer part of the study is led by Professor Meng Xianmin at Shanghai Public Health Clinical Center, while the SLE part is led by Professors Ye Shuang and Chen Sheng at Renji Hospital, Shanghai Jiaotong University School of Medicine. By targeting both the innate and adaptive immune systems via two clinically validated pathways that are known drivers of autoimmune disease, this complementary and differentiated approach has the potential to address multiple autoimmune indications with improved outcomes. LBL-047 (DNTH212) has the potential to be a first-line biologic with patient-friendly, S.C. self-administration and Q4W or less frequent dosing. On October 16, 2025, Leads Biolabs entered into an exclusive global partnership with Dianthus, with the total potential deal value reaching up to $1 billion. Under the agreement, Dianthus licensed exclusive globa...