Dapirolizumab pegol, a PEGylated anti-CD40 ligand Fab’ fragment, shows significant efficacy in improving moderate-to-severe systemic lupus erythematosus (SLE) disease activity at 48 weeks.
The large, multinational, randomized, double-blind, placebo-controlled PHOENYCS GO phase 3 trial demonstrated superior British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response rates with dapirolizumab compared to placebo.
Pharmacokinetic and exposure-response modeling support sustained drug exposure as important for maintaining clinical response.
Prior phase 1/2 studies indicate a favorable safety profile without increased thromboembolic risks, a known concern with CD40 ligand targeting therapies.
