Voclosporin, an investigational calcineurin inhibitor, is currently undergoing Phase 2 clinical trials for the treatment of lupus nephritis.1 The treatment is an immunosuppressant with a synergistic and dual mechanism and the potential to improve short- and long-term outcomes in lupus nephritis when added to standard of care treatments (i.e., mycophenolate mofetil [MMF]). Voclosporin is made by modifying a single amino acid on the cyclosporine molecule, which has a more predictable pharmacokinetic and pharmacodynamic relationship, with an increase in potency and an altered metabolic profile, resulting in the potential for flat dosing.
In April at the National Kidney Foundation 2017 Spring Clinical Meeting, the results of a global Phase 2B, 48-week study in lupus nephritis were unveiled.2 The study showed low-dose voclosporin (23.7 mg twice daily) was superior to placebo in helping patients achieve complete remission (49% vs. 24%, P<0.001) or partial remission (68% vs. 48%, P=0.007). Additionally, high-dose voclosporin (39.5 mg twice daily) also showed superior results compared with placebo in achieving complete remission (40% vs. 24%, P=0.26) or partial remission (72% vs. 48%, P=0.002).
