Dapirolizumab pegol achieves clinical improvement in moderate-to-severe lupus
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Dapirolizumab pegol met its primary endpoint, achieving clinical improvement, when combined with standard-of-care treatment for moderate-to-severe systemic lupus erythematosus, according to topline results announced by its manufacturers.
Compared with placebo, the novel Fc-free anti-CD40L drug candidate led to greater reductions in disease activity after 48 weeks, according to a press release from UCB and Biogen. There were also improvements in key secondary endpoints that measured disease activity and flares.
“Our hypothesis is that impacting the CD40L pathway, a central mechanism in immune response, would translate to significant impact on SLE disease burden,” Diana Gallagher, MD, head of the Alzheimer’s disease, multiple sclerosis and immunology development units at Biogen, said in the release. “These results demonstrate that dapirolizumab pegol has the promise to provide meaningful benefit in this serious, chronic and often devastating disease.”
According to the release, dapirolizumab pegol (UCB, Biogen) inhibits CD40L signaling, which reduces B-cell activation and production of autoantibodies, mitigates type 1 interferon secretion and attenuates activation of T cells and antigen-presenting cells.
The current study, a phase 3, double-blind, parallel-group trial called PHOENYCS GO, enrolled 321 patients with moderate-to-severe SLE. The primary endpoint was improvement in the British Isles Lupus Assessments Group-based Composite Lupus Assessment score after 48 weeks, compared with placebo combined with standard-of-care treatment.
The drug’s safety results were consistent with previous studies and with those expected in patients with SLE receiving an immunomodulator, according to the release.
Based on the results, UCB and Biogen announced a second phase 3 trial, PHOENYCS FLY, to commence later this year. Participants from PHOENYCS GO will be followed in a long-term open-label study.
“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,” Fiona du Monceau, head of patient evidence at UCB, said in the release. “We have confidence in the unique mode of action of dapirolizumab pegol, which targets multiple inflammatory pathways involved in the pathogenesis of SLE.”
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