UCB and Biogen Inc. (BIIB) have released detailed findings from their Phase 3 PHOENYCS GO study, which assessed the efficacy of dapirolizumab pegol, an Fc-free anti-CD40L drug candidate, in treating individuals with moderate-to-severe systemic lupus erythematosus. The study revealed marked clinical improvements in disease activity, successfully achieving its primary endpoint by demonstrating statistically and clinically significant enhancements across all organ systems. The company highlighted that participants treated with dapirolizumab pegol exhibited a notably greater response across various clinical endpoints, experiencing 50% fewer severe disease flare-ups compared to those receiving standard care alone. The safety profile of dapirolizumab pegol was generally well-tolerated.
Following the PHOENYCS GO study, participants will continue to be monitored through a long-term open-label study. Additionally, the companies plan to commence a second Phase 3 trial of dapirolizumab pegol, named PHOENYCS FLY.
