Biopharmaceutical company UCB (Euronext Brussels: UCB) and biotechnology company Biogen Inc (Nasdaq:BIIB) on Tuesday announced positive topline results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol, a novel anti-CD40L drug candidate, in patients with moderate-to-severe systemic lupus erythematosus (SLE).
Dapirolizumab pegol met the primary endpoint, demonstrating greater improvement in disease activity compared to placebo. The drug was also observed to improve other key secondary endpoints measuring disease activity and flares. The safety profile of dapirolizumab pegol was generally consistent with previous studies and expected for SLE patients receiving immunomodulators.
Based on these positive results, UCB and Biogen are initiating a second Phase 3 trial, PHOENYCS FLY, in 2024. Participants from the PHOENYCS GO study will continue to be followed in a long-term open-label study.
SLE is a chronic autoimmune disease that can affect multiple organ systems. It can present with various symptoms, including rash, arthritis, anaemia, thrombocytopenia, serositis, nephritis, seizures or psychosis.
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