Dapirolizumab Pegol Meets Primary Endpoint in Phase 3 Study for SLE

Fiona du Monceau

Credit: UCB

The phase 3 PHOENYCS GO study evaluating dapirolizumab pegol in addition to standard-of-care (SOC) treatment has met its primary endpoint of demonstrating clinical improvement in patients with moderate-to-severe systemic lupus erythematosus (SLE).¹

“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 a statement.¹ "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.”

Dapirolizumab pegol is a novel Fc-free anti-CD40L drug candidate. The PHOENYCS GO study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study which has enrolled 321 participants.

The study met its primary endpoint of demonstrating greater improvement of moderate-to-severe disease activity in addition to SOC as assessed by achievement of British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) after 48 weeks compared with placebo. The study also demonstrated clinical improvements among key secondary endpoints measuring disease activity and flares. The safety profile of dapirolizumab pegol was consistent with previous studies and the expected adverse events in people with SLE receiving an immunomodulator. Further data from the study will be presented at a future medical meeting.¹

UCB and Biogen plan to initiate a second phase 3 study of dapirolizumab pegol in 2024, termed PHOENYCS FLY, on the heels of the positive data. Participants in PHOENYCS GO study will continue to be followed in a long-term open-label study.¹

“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,” Diana Gallagher, MD, Head of AD, MS and Immunology Development Units at Biogen, added.¹ “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.”

The new announcement portends a promising possible addition to the treatment landscape of SLE. However, as more treatments become available, it becomes more important to carefully consider treatment decision making for SLE. Other recent research in this vein found that engagement of patients with SLE in shared decision-making increases patient trust in their clinicians and healthcare providers, which may enhance doctor-patient relationships and overall trust in healthcare.²

“The present study demonstrated the potential role of shared decision-making in building trust in physicians among patients with SLE, underscoring the significance of shared decision-making in ensuring confidence in decision-making in the management of SLE, where there is uncertainty regarding treatment efficacy and multiple treatment options,” investigators concluded.²

REFERENCES

1. UCB and Biogen Announce Positive Topline Results From Phase 3 Study of Dapirolizumab Pegol in Systemic Lupus Erythematosus and are Initiating Second Phase 3 Study in 2024. News release. UCB. September 24, 2024. https://investors.biogen.com/news-releases/news-release-details/ucb-and-biogen-announce-positive-topline-results-phase-3-study

2. Yoshimi R, Yajima N, Hidekawa C, et al. Effect of shared decision-making on trust in physicians in the management of systemic lupus erythematosus: The TRUMP2-SLE prospective cohort study. Arthritis Care Res (Hoboken). Published online August 4, 2024. doi:10.1002/acr.25409