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)

Core Insights - LBL-047 (DNTH212) is a bifunctional fusion protein targeting plasmacytoid dendritic cells to reduce Type 1 interferon production and inhibit B cell function, with top-line results expected in the second half of 2026 [1][4] - The drug has the potential to be a first-line biologic for multiple autoimmune disorders, offering patient-friendly subcutaneous self-administration and dosing every four weeks or less [1][3] Company Overview - Leads Biolabs is a clinical-stage biotechnology company focused on developing innovative therapies for oncology, autoimmune, and severe diseases, with a pipeline of 14 drug candidates, including six in clinical stages [10][11] - Dianthus Therapeutics is also a clinical-stage biotechnology company dedicated to next-generation therapies for severe autoimmune diseases, with a team of experienced biotech and pharma executives [9] Clinical Trial Details - The Phase 1 trial of LBL-047 (DNTH212) is a two-part, double-blind, randomized, placebo-controlled study designed to evaluate safety, tolerability, and pharmacokinetics in healthy volunteers and patients with systemic lupus erythematosus [2] - The trial is being conducted in collaboration with leading medical professionals in Shanghai, with the healthy volunteer part led by Professor Meng Xianmin and the SLE part by Professors Ye Shuang and Chen Sheng [2] Partnership and Development - Leads Biolabs entered an exclusive global partnership with Dianthus, with a total potential deal value of up to $1 billion, allowing Dianthus to develop and commercialize LBL-047 outside Greater China [4] - Dianthus plans to provide updates on prioritized indications for DNTH212 in the first half of 2026 [4]