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

Clinical Trial Results - Dapirolizumab pegol (DZP) met its primary endpoint, showing statistically and clinically significant improvement across all organ systems as measured by BICLA, with a 14.6% higher response rate (49.5%) compared to standard of care (SOC) alone (34.6%) [1][2] - Participants receiving DZP experienced 50% fewer severe disease flares compared to those on SOC alone [1] - At Week 24, DZP plus SOC showed a 7.9% higher BICLA response rate (46.6%) compared to SOC alone (38.3%), though the difference was not statistically significant [3] Secondary Endpoints and Clinical Improvements - 17.1% more participants receiving DZP reduced their corticosteroid dose from >7.5 mg/day to ≤7.5 mg/day at Week 48 (72.4% vs. 52.9%) [4] - DZP plus SOC showed an 18.8% higher SRI-4 response rate at Week 48 (60.1% vs. 41.1%) [4] - A 1.8-fold greater decrease in SLEDAI-2K was observed in the DZP group compared to SOC alone at Week 48 (-6.1 vs. -4.2) [4] - 20.9% more participants in the DZP group achieved Lupus Low Disease Activity State (LLDAS) at Week 48 (40.9% vs. 19.6%) [4] Safety Profile - The safety profile of DZP was generally favorable, with 82.6% of participants experiencing treatment-emergent adverse events (TEAEs) compared to 75.0% in the SOC group [6] - Serious TEAEs were reported in 9.9% of participants receiving DZP plus SOC compared to 14.8% in the SOC group [6] - Opportunistic infections were reported in 2.8% of participants receiving DZP plus SOC compared to 0.9% in the SOC group [6] Disease Background - Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease affecting multiple organ systems, primarily in women, with 90% of cases occurring in women aged 15-55 [9] - SLE is associated with a higher risk of death from infections and cardiovascular disease, and pregnancy in women with SLE carries higher maternal and fetal risks [9] Drug Mechanism and Development - Dapirolizumab pegol is a novel Fc-free anti-CD40L drug candidate that inhibits CD40L signaling, reducing B cell activation and autoantibody production [10] - The drug is currently in Phase 3 clinical development for SLE under a collaboration between UCB and Biogen [10] Company Information - UCB is a global biopharmaceutical company focused on severe diseases of the immune system and central nervous system, listed on Euronext Brussels [11] - Biogen is a leading biotechnology company pioneering innovative science to deliver new medicines, founded in 1978 [12]