On November 19, 2024, UCB and Biogen Inc. presented detailed results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol (DZP) at ACR Convergence 2024, the American College of Rheumatology’s annual meeting. The data demonstrated significant clinical improvement in disease activity for individuals living with moderate-to-severe systemic lupus erythematosus (SLE).
In the PHOENYCS GO study (n=321), participants receiving DZP plus standard-of-care (SOC) showed a statistically significant 14.6% higher response rate (49.5%) on the primary endpoint, British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA), at Week 48 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.
Subsequent analyses of additional secondary endpoints revealed clinical improvements in the DZP group, including SLE Responder Index (SRI)-4 response, corticosteroid tapering, and prevention of severe BILAG flares. The safety profile of dapirolizumab pegol was generally favorable and consistent with previous studies. Based on these results, UCB and Biogen plan to initiate a second Phase 3 trial, PHOENYCS FLY, in 2024, further advancing this potential treatment for SLE.
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