Phase 3 data shows Dapirolizumab pegol is effective in treating SLE, reducing fatigue and disease activity.

From GlobeNewswire: 2025-06-12 01:00:00

Dapirolizumab pegol (DZP) demonstrated efficacy in treating systemic lupus erythematosus (SLE) in the PHOENYCS GO study, improving fatigue and disease activity measures. Participants receiving DZP showed significant improvements in fatigue compared to standard care, with more experiencing no or low disease activity at Week 48. A Phase 3 trial is ongoing to confirm these results. DZP also showed promise in helping patients achieve remission and low disease activity, potentially reducing long-term organ damage and glucocorticoid exposure. The safety profile of DZP was generally favorable, with a higher proportion of participants experiencing adverse events in the DZP group.

SLE is a chronic autoimmune disease affecting multiple organ systems, with symptoms like rash, arthritis, and nephritis. DZP is a novel Fc-free anti-CD40L drug candidate that has shown significant clinical improvements in SLE disease activity, fatigue, and remission. The results were presented at EULAR 2025, showing the potential for DZP to become a new medication for people living with SLE. A second Phase 3 trial of DZP is ongoing. Individuals from certain populations are at higher risk for more aggressive SLE, emphasizing the need for effective treatments like DZP. In the PHOENYCS GO study, Dapirolizumab pegol (DZP) demonstrated effectiveness in improving fatigue and disease activity in patients with systemic lupus erythematosus (SLE). By Week 48, more individuals on DZP had lower disease activity compared to standard care, with improvements seen as early as Week 12. DZP inhibits CD40L signaling to reduce B cell activation, autoantibody production, type 1 interferon secretion, and T cell and antigen-presenting cell activation. Currently in Phase 3 development for SLE, DZP is a collaborative effort between UCB and Biogen, global biopharmaceutical companies focused on innovative treatments for severe diseases. Dapirolizumab pegol (DZP) has shown effectiveness in treating systemic lupus erythematosus (SLE) by improving fatigue and reducing disease activity in the PHOENYCS GO study. Results at Week 48 showed more patients on DZP had low or no disease activity compared to standard care, with improvements seen as early as Week 12. UCB is closely monitoring the development for financial implications. Biogen also announced a new strategy for sustainable growth, highlighting the potential of its late-stage pipeline and ongoing product launches like LEQEMBI. These statements are forward-looking and subject to risks and uncertainties in drug development and commercialization. Dapirolizumab pegol (DZP) demonstrated effectiveness in treating systemic lupus erythematosus (SLE) in the PHOENYCS GO study. Results showed improvements in fatigue and disease activity, with more patients on DZP experiencing low disease activity compared to standard care. The study found positive outcomes as early as Week 12, lasting through Week 48. These findings offer hope for SLE patients struggling with symptoms. However, uncertainties remain, as with any medical research, and further studies are needed to validate these results. SLE affects a significant number of individuals worldwide, highlighting the importance of continued research and treatment development in this area.



Read more at GlobeNewswire: Dapirolizumab Pegol Phase 3 Data in SLE Presented at the