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.
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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).
All prespecified secondary study endpoints analyzed to date were met at Week 48. These endpoints include the time to complete and partial remission, reduction in Systemic Lupus Erythematosus Disease Activity Index score and reduction in urine protein creatinine ratio. Voclosporin was generally well tolerated with no unexpected safety signals. Renal function measured by eGFR was stable and not significantly different from the study’s control arm. Mean blood pressures were also similar between the two groups.
Phase 3 trials are currently enrolling patients.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
- Aurinia Pharmaceuticals Inc. News release: Aurinia releases additional 48-week data from the AURA-LV study during late-breaking session at the National Kidney Foundation 2017 Spring Clinical Meetings. 2017 Apr 20.
- Aurinia Pharmaceuticals Inc. Aurinia renal response in active lupus with Orelvo (voclosporin) (AURORA). ClincalTrials.gov. 2017 May.