Dapirolizumab pegol plus standard-of-care treatment met the primary endpoint in a Phase 3 study of moderate-to-severe systemic lupus erythematosus (SLE), according to topline results from PHOENYCS GO.
The results are considered surprising since dapirolizumab pegol, a novel Fc-free anti-CD40L drug candidate, failed in an earlier Phase 2 study.
In PHOENYCS GO, dapirolizumab pegol plus standard-of-care demonstrated 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 vs. placebo and standard-of-care. Clinical improvements were observed among key secondary endpoints measuring disease activity and flares, UCB and Biogen report.
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 3 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.
More on PHOENYCS GO
PHOENYCS GO (n= 321) is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study of dapirolizumab pegol as an add on therapy to standard of care compared to placebo with standard of care. The primary outcome measure was improvement of moderate-to-severe disease activity at Week 48 using BICLA, an established, composite primary efficacy endpoint for measurement of clinical disease activity based on patient medical history, clinical examination and laboratory tests. Standard of care included ≤40 mg/day prednisone-equivalent, antimalarial or immunosuppressant drugs,
“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,” says Fiona du Monceau, Head of Patient Evidence at UCB, in a news release. “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.”
“Our hypothesis is that impacting the CD40L pathway, a central mechanism in immune response, would translate to significant impact on SLE disease burden. These results demonstrate that dapirolizumab pegol has the promise to provide meaningful benefit in this serious, chronic, and often devastating disease,” adds Diana Gallagher, MD, Head of AD, MS and Immunology Development Units at Biogen. “We are committed to delivering new treatment options for this autoimmune disease and believe the overall efficacy and safety seen in PHOENYCS GO support further development of dapirolizumab pegol in SLE.”
