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Dapirolizumab pegol (DZP) Phase 3 study presentations in SLE to show efficacy results across multiple clinical endpoints, including low disease activity/remission, flares, fatigue, joint pain and quality of life
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Presentation of preclinical study of DZP showing minimal to no human placental transfer
CAMBRIDGE, Mass., Oct. 22, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced upcoming presentations from studies evaluating dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L drug candidate, in systemic lupus erythematosus (SLE) to be presented at the American College of Rheumatology (ACR) Convergence 2025 (October 24-29) 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 at Biogen. “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 (NCT06617325), is ongoing.1,2 Dapirolizumab pegol is being developed under a collaboration between Biogen and UCB.
Details of the presentations are as follows:
Title: Improvement of Fatigue, Musculoskeletal Pain, and Morning Stiffness in Patients with Systemic Lupus Erythematosus Treated with Dapirolizumab Pegol: 48-Week Results from a Phase 3 Trial
Poster Presentation Date & Time: Sunday, October 26, 2025, Poster Session A, 10:30 AM -12:30 PM CT / 11:30 AM – 1:30 PM ET
Poster Number: 0644
Title: Achievement of Low Disease Activity and Remission in Patients with Systemic Lupus Erythematosus Treated with Dapirolizumab Pegol: 48-Week Results from a Phase 3 Trial
Poster Presentation Date & Time: Sunday, October 26, 2025, Poster Session A, 10:30 AM -12:30 PM CT / 11:30 AM – 1:30 PM ET
Poster Number: 0645
Title: Alternative Definitions of Moderate Flares that Simulate Clinical Practice in Systemic Lupus Erythematosus: Post Hoc Exploration of Moderate Flares in Patients Treated with Dapirolizumab Pegol in a 48-Week Phase 3 Trial
Poster Presentation Date & Time: Monday, October 27, 2025, Poster Session B, 10:30 AM -12:30 PM CT / 11:30 AM – 1:30 PM ET
Poster Number: 1542
Title: Dapirolizumab Pegol Demonstrated Improvement in Quality of Life of Patients with Systemic Lupus Erythematosus: LupusQoL Results from a Phase 3 Trial
Poster Presentation Date & Time: Tuesday, October 28, 2025, Poster Session C, 10:30 AM -12:30 PM CT / 11:30 AM – 1:30 PM ET
Poster Number: 2441
Title: Dapirolizumab Pegol, a Novel CD40L Inhibitor, Showed No Adverse Outcomes in an In Vivo Non-Human Primate Reprotoxicity Study and Displayed Minimal to No Human Placental Transfer in an Ex Vivo Study
Abstract Presentation Date & Time: Tuesday, October 28, 2025, Abstract Session, 4:00-4:15 PM CT / 5:00-5:15 PM ET
Abstract Number: 2631
About Dapirolizumab Pegol
Dapirolizumab pegol is a novel investigational humanized Fc-free polyethylene glycol (PEG)-conjugated antigen-binding (Fab’) fragment. Dapirolizumab pegol inhibits 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.3 Dapirolizumab pegol is presently in Phase 3 clinical development for the treatment of systemic lupus erythematosus (SLE) under a collaboration between UCB and Biogen.1,2
About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient’s lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.
References:
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Clinicaltrials.gov (NCT04294667). A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus (PHOENYCS GO) 2023. Available at: https://clinicaltrials.gov/ct2/show/NCT04294667. Retrieved September 22, 2025.
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Clinicaltrials.gov (NCT06617325). A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus (PHOENYCS FLY) 2024. Available at https://clinicaltrials.gov/study/NCT06617325. Retrieved September 22, 2025.
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Furie RA, Bruce IN, Dörner T, et al. Phase 2 randomized, placebo-controlled trial of dapirolizumab pegol in patients with moderate to severe active systemic lupus erythematosus (SLE). Rheumatology (Oxford).2021;60(11): 5397-407.