Partners UCB (FRA: UNC) and Biogen Inc. (NASDAQ: BIIB) have announced positive results from a Phase III study of their co-developed drug candidate, dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L agent, when combined with the standard-of-care (SOC) in patients with moderate-to-severe systemic lupus erythematosus (SLE). The findings, which indicate a significant reduction in disease activity, were presented at ACR Convergence 2024 in Washington, DC.
Study Design and Primary Endpoint
In the study, dapirolizumab pegol (DZP) was administered intravenously every four weeks. The primary endpoint, measuring the improvement of moderate-to-severe disease activity as assessed by the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) after 48 weeks, showed that patients receiving DZP plus SOC had a statistically significant 14.6% higher response rate (49.5%) compared to those receiving SOC alone (34.6%). This higher BICLA response rate indicates a treatment response across all affected organs at baseline and is associated with meaningful clinical benefit.
Secondary Endpoint and Statistical Significance
Regarding the first secondary endpoint of BICLA response at Week 24, patients receiving DZP plus SOC exhibited a 7.9% higher response rate (46.6%) than those on SOC alone (38.3%). However, this difference did not reach statistical significance.
Dapirolizumab Pegol’s Mechanism of Action
Dapirolizumab pegol is a novel investigational humanized Fc-free polyethylene glycol (PEG)-conjugated antigen-binding (Fab’) fragment. It works by inhibiting CD40L signaling, which has been shown to reduce B cell activation and autoantibody production, mitigate type 1 interferon (IFN) secretion, and attenuate T cell and antigen-presenting cell (APC) activation.-Fineline Info & Tech
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