Aurinia Pharmaceuticals' (TSE:AUP) Phase IIb with voclosporin for the treatment of lupus nephritis (LN) has experts skeptical that it will achieve its primary endpoint of complete remission. They noted that complete remission is a high bar and a subjective measurement.
Voclosporin is a calcineurin inhibitor (CNI). Other CNIs, including cyclosporine and tacrolimus, are used off-label in the treatment of LN.
Data is expected from AURA-LV in 3Q16, according to a January company press release. It has three treatment arms: low dose voclosporin with background treatment of mycophenolate mofetil (MMF) and corticosteroids, high dose voclosporin with background treatment of MMF and corticosteroids and a placebo arm.
Complete remission is hard to achieve with current therapies, said an Aurinia executive. The standard of care only achieves a 10%-20% remission rate, but the layering effect of the AURA-LV study supports a better remission rate, he explained. The study is powered to show a 41% remission, the executive said, adding that the remission endpoint is actually a low bar because the standard of care performs so badly.