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Aurinia Presents AURORA Pivotal Trial Subgroup Analysis at the EULAR 2020 E-Congress
- All pre-specified subgroup analyses in the pivotal trial favored voclosporin over placebo - VICTORIA, British Columbia--(BUSINESS WIRE)-- Aurinia
About this update from Aurinia Pharmaceuticals Inc
[{"type":"text","content":"\n- All pre-specified subgroup analyses in the pivotal trial favored voclosporin over placebo -\n\n VICTORIA, British Columbia--(BUSINESS WIRE)--\n\nAurinia Pharmaceuticals Inc. (Nasdaq:AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple indications, announced that new subgroup analyses from the completed AURORA pivotal trial of voclosporin were presented. The data were shared today 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).\n\n\nThe 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.\n\n\n“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.”\n\n\nAs 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 \n\nVoclosporin 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....