Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor (CNI) with clinical data in over 2,600 patients across indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action. By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses and stabilizes the podocyte in the kidney. Potential benefits may include a more predictable pharmacokinetic and pharmacodynamic relationship (potentially requires no therapeutic drug monitoring), an increase in potency (vs cyclosporin), and an improved metabolic profile compared to legacy CNIs.
Voclosporin, an investigational compound, has a synergistic, dual mechanism of action that may have the potential to improve near and long-term outcomes in patients with LN when added to mycophenolate mofetil (MMF) and low oral corticosteroids. Aurinia has successfully completed a Phase 3 clinical study with voclosporin for the treatment of lupus nephritis.
We successfully completed AURORA, a global placebo-controlled pivotal Phase 3 study that aimed to evaluate whether voclosporin added to mycophenolate mofetil (MMF) could increase speed of remission and overall remission rates in the presence of low doses of steroids.
Patients completing the AURORA trials had the option to roll over into a 104-week blinded extension study. This study is currently enrolling and will allow us to assess long-term outcomes in LN patients.
Voclosporin is a structural analog of cyclosporine A, developed to potentially offer a number of advantages over legacy calcineurin inhibitors including:
Voclosporin binds to calcineurin through the latch region.