Aurinia presents AURORA pivotal trial subgroup analysis of voclosporin for lupus nephritis at the EULAR 2020 E-Congress.

Aurinia Pharmaceuticals Inc. announced that new subgroup analyses from the completed AURORA pivotal trial of voclosporin were presented at the European League Against Rheumatism (EULAR) 2020 E-Congress in an oral presentation given by Cristina Arriens, M.D., M.S.C.S., Clinical Assistant Member of the Arthritis and Clinical Immunology Research Program at the Oklahoma Medical Research Foundation (OMRF).

The presented data demonstrated clinically meaningful benefits of voclosporin for trial participants across ethnicities and self-reported race. Significant renal response rates were seen for Hispanic/Latino (p=0.0062, OR 3.45) patients in the voclosporin arm (38.6%) versus control arm (18.6%), as well as for non-Hispanic/Latino patients (p=0.0045, OR 2.29) in the voclosporin arm (41.8%) versus the control arm (24.6%). Furthermore, all other pre-specified subgroup analyses (age, sex, race, biopsy class, region, and prior mycophenolate mofetil use) favored voclosporin.

“The robustness of renal response across race and ethnicity and the onset of voclosporin effect have the potential to change the natural course of this debilitating disease,” stated Neil Solomons, M.D., Chief Medical Officer of Aurinia. “The treatment benefits observed across all clinically important subgroups further strengthens our confidence in voclosporin as a potential treatment for people living with lupus nephritis.”

As previously reported, AURORA met its primary endpoint, achieving statistically superior Renal Response rates of 40.8% for voclosporin vs. 22.5% for the control (OR 2.65, 95% CI; p < 0.001). The benefits of voclosporin were also seen for all prespecified hierarchical secondary endpoints, achieving statistical significance in favor of voclosporin for Renal Response at 24 weeks, Partial Renal Response at 24 and 52 weeks, time to achieve urinary protein-to-creatinine ratio (UCPR) less than 0.5, and time to 50% reduction in UPCR.

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. Overall mortality in the trial was low, with six deaths observed; one in the voclosporin arm and five in the control group. Additionally, the voclosporin arm showed no significant decrease at week 52 in estimated glomerular filtration rate (eGFR) or increase in blood pressure, lipids or glucose, which are common adverse events associated with legacy calcineurin inhibitors (CNIs).

The data presented at EULAR 2020 was submitted as part of voclosporin’s new drug application (NDA) to the FDA which was completed on May 25, 2020.