Positive topline results from phase III study of dapirolizumab pegol in systemic lupus erythematosus and initiation of second phase III study in 2024
UCB and Biogen Inc. announced positive topline results from the Phase III PHOENYCS GO study evaluating dapirolizumab pegol, a novel Fc-free anti-CD40L drug candidate, in people living with moderate-to-severe systemic lupus erythematosus (SLE)
Dapirolizumab pegol, in addition to standard-of-care (SOC) treatment, met the primary endpoint to demonstrate greater 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 versus placebo in addition to SOC. Clinical improvements were observed among key secondary endpoints measuring disease activity and flares.
The safety profile of dapirolizumab pegol was generally consistent with previous studies and with that expected in study participants with systemic lupus erythematosus receiving an immunomodulator.
Based on the successful outcome of the PHOENYCS GO study, UCB and Biogen are initiating a second Phase III trial of dapirolizumab pegol in 2024, PHOENYCS FLY. Participants from the PHOENYCS GO study will continue to be followed in a long-term open-label study.
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