24 September ，UCB and Biogen Inc. today announced positive topline results from the Phase 3 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.
“These positive results with dapirolizumab pegol represent encouraging progress in the development of medicines that can improve the lives of those living with lupus, an area that remains one of high unmet medical need and where women are disproportionately affected,” said Fiona du Monceau, Head of Patient Evidence at UCB. "We have confidence in the unique mode of action of dapirolizumab pegol which targets multiple inflammatory pathways involved in the pathogenesis of SLE. As we pursue the next steps in the clinical development of this potentially differentiated treatment, we extend our appreciation to the patients, study investigators and the clinical community for their ongoing support and participation in this important research.”
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