Updated data on Aurinia Pharmaceuticals Inc.’s voclosporin suggest the calcineurin inhibitor could get more lupus nephritis patients into remission faster than current therapies while reducing reliance on toxic standards of care. But first the company needs to show that an imbalance in mortality in Phase IIb testing was due to chance.
Previously reported data from the 265-patient Phase IIb AURA-LV study suggested that when voclosporin is added to standard of care, it can induce remissions in a greater proportion of patients than SOC by itself, even as patients dramatically reduce their use of steroids.
AURA-LV tested 23.7 or 39.5 mg voclosporin twice daily. SOC consisted of CellCept mycophenolate mofetil and corticosteroid.
The low dose met the primary endpoint with 33% of patients in complete remission at week 24 vs. 19% for SOC alone (p=0.045). The high dose trended toward improvement with 27% of patients in complete remission.
“We believe from long-term follow-up data that the earlier you get into renal remission, the better your long-term