Biogen to present additional results from Phase 3 study of dapirolizumab pegol

Biogen (BIIB) announced upcoming presentations from studies evaluating dapirolizumab pegol, a novel Fc-free anti-CD40L drug candidate, in systemic lupus erythematosus to be presented at the American College of Rheumatology Convergence 2025 in Chicago, Illinois. The presentations will show efficacy results of DZP across multiple endpoints including low disease activity/remission, flares, fatigue, joint pain and quality of life. Additional preclinical data will also be presented, demonstrating minimal to no placental transfer of DZP supporting further study in women before, during and after pregnancy. “The data we are presenting at ACR Convergence strengthen our understanding of the range of effects dapirolizumab pegol has in systemic lupus erythematosus, suggesting it has the potential to broadly impact this chronic and debilitating disease,” said Diana Gallagher, MD, Head of AD, MS and Immunology Development Units. “The novel flare analysis of the Phase 3 data presented at ACR, as well as data on quality-of-life metrics and disease activity, further support the potential of dapirolizumab pegol to be a meaningful new therapy in systemic lupus erythematosus. Biogen is committed to advancing its late-stage clinical pipeline which includes programs focusing on the diverse unmet needs of the lupus community.” Dapirolizumab pegol is one of only three biologics to report positive Phase 3 data in a global SLE study. The additional data presented from the PHOENYCS GO trial at ACR suggest a broad impact across endpoints in this Phase 3 study. In the Phase 3 study, DZP met the primary endpoint of improvement of moderate-to-severe disease activity as assessed by achievement of BICLA after 48 weeks. As the first key secondary endpoint had a p-value = 0.1776, all subsequent secondary and tertiary endpoints are descriptive and nominal p-values are included. A second Phase 3 study, PHOENYCS FLY, is ongoing.1,2 Dapirolizumab pegol is being developed under a collaboration between Biogen and UCB.