Biogen, UCB present results from Phase 3 PHOENYCS GO study of DZP

UCB and Biogen (BIIB) presented additional detailed results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol, DZP, a novel Fc-free anti-CD40L drug candidate. In the study, DZP demonstrated significant clinical improvements in disease activity in people living with moderate-to-severe systemic lupus erythematosus, as measured by the British Isles Lupus Assessment Group-based Composite Lupus Assessment at Week 48, the primary endpoint. Improvements were also seen across additional clinical measures, including fatigue and disease activity/remission. These results were presented at EULAR 2025, the European Alliance of Associations for Rheumatology’s annual meeting, in Barcelona, Spain. The safety and efficacy of DZP in SLE have not been established, and it is not approved for use in SLE by any regulatory authority worldwide. A second Phase 3 trial of dapirolizumab pegol is ongoing with the goal of confirming the results from PHOENYCS GO. In an analysis of the impact of DZP on patient-reported fatigue in people with SLE participating in the PHOENYCS GO study, individuals receiving DZP in addition to standard of care treatment demonstrated improvements across two fatigue measurements: Improvements in Functional Assessment of Chronic Illness Therapy-Fatigue scores were greater in the DZP group, compared with SOC alone at Week 48. Using FATIGUE-PRO, a measure recently developed to capture the patient experience of fatigue in SLE, greater improvements from baseline were observed in people receiving DZP compared with SOC alone in the Physical Fatigue, Mental and Cognitive, and Susceptibility to Fatigue scales at Week 48.