AURORA phase III trial of Luveniq meets primary endpoint in lupus nephritis.- Aurinia Pharma

Aurinia Pharmaceuticals Inc. announced positive top-line results announced positive efficacy and safety results from its pivotal AURORA Phase III trial of Luveniq (voclosporin), in combination with mycophenolate and low-dose corticosteroids, in the treatment of lupus nephritis. The study met all of its primary and secondary endpoints of achieving complete remission in a statistically significant number of study participants who received voclosporin in combination with standard of care.

This global study in which 357 patients with active LN were enrolled, met its primary endpoint of Renal Response rates of 40.8% for voclosporin vs. 22.5% for the control (OR 2.65; p < 0.001). Additionally, all pre-specified hierarchical secondary endpoints achieved statistical significance in favor of voclosporin, which included Renal Response at 24 weeks, Partial Renal Response at 24 and 52 weeks, time to achieve urinary protein-to-creatinine ratio (UPCR) less than 0.5, and time to 50% reduction in UPCR. The robustness of the data was also supported by all pre-specified subgroup analyses (age, sex, race, biopsy class, region, and prior MMF use) favoring voclosporin.

Voclosporin was well tolerated with no unexpected safety signals. Serious adverse events (SAEs) were reported in 20.8% of voclosporin patients vs. 21.3% in the control arm. Infection was the most commonly reported SAE with 10.1% of voclosporin patients versus 11.2% of patients in the control arm.