UCB and Biogen have unveiled detailed Phase 3 results for dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L drug candidate, demonstrating significant improvements in managing moderate-to-severe systemic lupus erythematosus (SLE). Findings from the PHOENYCS GO study were presented as a late-breaking oral presentation at the 2024 ACR Convergence in Washington, DC.
Promising Results in Disease Management
In the 321-participant study, DZP administered every four weeks showed a statistically significant improvement in disease activity when combined with standard-of-care (SOC) treatment. At 48 weeks, 49.5% of participants receiving DZP plus SOC achieved a BICLA (British Isles Lupus Assessment Group-based Composite Lupus Assessment) response, compared to 34.6% with SOC alone, a 14.6% higher response rate (p=0.0110).
Additional secondary endpoint results highlighted:
- Corticosteroid Reduction: 72.4% of participants on DZP tapered their corticosteroid dose to ≤7.5 mg/day by Week 48, compared to 52.9% on SOC alone (p=0.0404).
- SLE Responder Index-4 (SRI-4): A higher response rate of 60.1% versus 41.1% (p=0.0014).
- Lupus Low Disease Activity State (LLDAS): Achieved by 40.9% of DZP-treated participants versus 19.6% with SOC alone (p<0.001).
- Severe Flares: Participants on DZP experienced 50% fewer severe BILAG flares than those on SOC alone.
Expert Insights
“There remains an unmet need for effective treatments for SLE. The PHOENYCS GO results suggest dapirolizumab pegol could provide meaningful clinical benefits, including reduced disease activity and corticosteroid tapering,” said Dr. Megan E.B. Clowse of Duke University School of Medicine.
Safety Profile
The safety results aligned with previous studies, showing a favorable profile. While treatment-emergent adverse events (TEAEs) were higher in the DZP group (82.6% vs. 75.0%), serious TEAEs were lower (9.9% vs. 14.8%). Opportunistic infections were slightly more common with DZP (2.8% vs. 0.9%), and treatment discontinuation rates due to TEAEs were similar between groups.
Next Steps
UCB and Biogen are advancing the clinical program with a second Phase 3 trial, PHOENYCS FLY, set to launch in 2024. Long-term follow-up studies are also underway to further evaluate DZP’s efficacy and safety.
“With its targeted approach to the CD40L pathway, dapirolizumab pegol shows promise in addressing the burden of SLE, particularly for women disproportionately affected by the disease,” said Fiona du Monceau, Head of Patient Evidence at UCB.
Though not yet approved by any regulatory authority, these results strengthen the case for DZP as a potential new option for managing SLE.
