On September 24, 2024, Biogen Inc. and its Belgian partner UCB announced positive topline results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol, an experimental treatment for moderate-to-severe systemic lupus erythematosus (SLE). The drug candidate met its primary endpoint, demonstrating a greater improvement in disease activity as assessed by the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) after 48 weeks, compared to placebo when added to standard-of-care treatment.
The study observed clinical improvements across key secondary endpoints that measured disease activity and flares. The safety profile of dapirolizumab pegol was generally consistent with findings from previous studies and aligned with expectations for participants with SLE receiving an immunomodulator. This outcome is particularly encouraging given that the drug had previously failed an earlier mid-stage study.
Based on the successful results of the PHOENYCS GO study, Biogen and UCB are proceeding with the initiation of a second Phase 3 trial for dapirolizumab pegol, named PHOENYCS FLY, in 2024. This advancement underscores the potential of dapirolizumab pegol to address the significant unmet medical needs of patients living with lupus, a chronic autoimmune disease that disproportionately affects women.
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