Dapirolizumab Pegol Phase 3 Data Presented at the American College of Rheumatology Shows Significant Reduction in Systemic Lupus Erythematosus Disease Activity

• Dapirolizumab pegol (DZP) met its primary endpoint, demonstrating statistically and clinically significant improvement across all organ systems as measured by BICLA, an endpoint measuring disease activity
• A greater response was observed across multiple clinical endpoints among participants treated with DZP including 50% less severe disease flares compared to participants on standard of care alone
• Systemic Lupus Erythematosus is a chronic, debilitating autoimmune disease affecting multiple organ systems, primarily in women, for whom there is a significant need for additional treatment options

BRUSSELS, Belgium and CAMBRIDGE, Mass., Nov. 19, 2024 (GLOBE NEWSWIRE) — UCB ( Euronext (EPA:) Brussels: UCB) and Biogen Inc. (NASDAQ: NASDAQ:) today presented detailed results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L drug candidate, demonstrating significant clinical improvement in disease activity in people living with moderate-to-severe systemic lupus erythematosus (SLE). The results were shared during an oral, late-breaker presentation at ACR Convergence 2024, the American College of Rheumatology’s annual meeting, in Washington, DC.

There remains a significant unmet need for additional treatment options for people living with systemic lupus erythematosus and the results we observed in PHOENYCS GO suggest dapirolizumab pegol has the potential to be impactful for this chronic and debilitating autoimmune disease. Across clinical endpoints we observed a positive effect and a favorable safety profile, said Megan E.B. Clowse, M.D., principal investigator of the study and Associate Professor of Medicine, Chief of the Division of Rheumatology and Immunology at Duke University School of Medicine. Participants receiving dapirolizumab pegol experienced reduced lupus activity while also tapering steroids, changes important to people living with the disease.

In the PHOENYCS GO study (n=321), dapirolizumab pegol (DZP) was administered intravenously every four weeks. On the primary endpoint measuring improvement of moderate-to-severe disease activity as assessed by achievement of British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) after 48 weeks, study participants receiving DZP plus SOC had a statistically significant 14.6% (95% confidence interval [CI]: 3.3, 25.8; p=0.0110) higher response rate (49.5%) than those receiving SOC alone (34.6%). A higher BICLA response rate reflects a…