Dianthus Therapeutics (NASDAQ:DNTH) and Nanjing Leads Biolabs Co., announced the initiation of a Phase 1 clinical trial for LBL-047 (also known as DNTH212), a bifunctional fusion protein designed to treat severe autoimmune conditions.
The first subject was dosed on December 23, 2025, marking the first clinical milestone of a global partnership valued at up to $1 billion.
The investigational therapy employs a "dual-action" mechanism that simultaneously targets two clinically validated pathways.
By inhibiting the BDCA2 protein on plasmacytoid dendritic cells, it aims to reduce Type 1 interferon production; concurrently, it blocks the BAFF and APRIL proteins to suppress B-cell survival.
This integrated approach is intended to provide superior efficacy over existing single-target biologics for patients with systemic lupus erythematosus (SLE).
The Phase 1 study is a two-part, randomized, double-blind trial conducted in China.
Part A will evaluate safety and pharmacokinetics in healthy volunteers, while Part B will focus on patients with SLE.
Dianthus, which secured exclusive rights to the drug outside of Greater China in October, anticipates top-line data from the healthy volunteer portion in the second half of 2026.