Luveniq voclosporin: Phase IIb data
Top-line data from the double-blind, international Phase IIb AURA-LV trial in 265 patients with active lupus nephritis showed that twice-daily 23.7 mg oral voclosporin plus standard of care (SOC) mycophenolate mofetil (MMF) and oral corticosteroids met the primary endpoint of a greater proportion of patients achieving complete remission at 24 weeks vs. placebo plus MMF and oral corticosteroids (32.6% vs. 19.3%, p=0.045). The twice-daily 39.5 mg dose of voclosporin plus MMF and oral corticosteroids missed the primary endpoint vs. placebo plus MMF and oral corticosteroids (27.3%, p=0.204). Both low- and high-dose voclosporin plus MMF and oral corticosteroids met the secondary endpoint of a greater proportion of patients achieving partial remission, defined as a 50% reduction in urine protein/creatinine ratio over baseline, at 24 weeks vs. placebo plus MMF and oral corticosteroids (69.7%, and 65.9%, respectively, vs. 49.4%, p=0.007 and p=0.024). ...