Aurinia Pharmaceuticals Inc (NASDAQ:AUPH) a clinical stage biopharma firm focused on the worldwide immunology market, released top-line report from its Phase 2b AURA-LV trial in lupus nephritis. At 48 weeks, the study achieved the partial and complete remission endpoints, showing statistically significantly greater PR and CR in subjects in both low dose and high dose cohorts compared to the control group.
The details
Each arm of the trial comprised the existing standard of care of MMF as background treatment and a forced steroid taper to 5mg per day by week 8 and 2.5mg/day by week 16. No unanticipated safety signals were noted and there were no cases of additional deaths in the voclosporin cured patients; however, there were 3 deaths and one malignancy recorded in the control arm after closure of the trial treatment period.
Additional data assessments for the AURA trial at 48 weeks will be launched at future corporate, scientific and medical meetings. Lupus nephritis is one of the most serious conditions of systemic lupus erythematosus. The existing treatments of LN are lethal and the complete renal response rates are excessively low.
For the last numerous years, the lupus researcher’s community in association with the pharma industry have been involved in finding more effective treatments for LN, but achievement has been tough to achieve. Brad Rovin, MD, FASN, reported that the AURA study’s long-term report convincingly show that the inclusion of voclosporin to standard of care therapy is a better option over standard of care alone.
This report is not only statistically notable, but clinically vital. Twice as many subjects administered 23.7mg voclosporin two times per day attained a complete renal response as against to those cured with placebo. This is a remarkable renal response rate and this data may shift the treatment model of LN. Based on these promising data, Aurinia Pharmaceuticals is looking forward to the planned Phase 3 study of voclosporin in LN.
