Aurinia Pharmaceuticals (AUPH) Announces Late-Breaking Presentation of Voclosporin Phase IIb AURA Data; Primary Endpoint Met
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Aurinia Pharmaceuticals Inc. (Nasdaq: AUPH) announced highlights from its global Phase IIb AURA study of voclosporin in the treatment of lupus nephritis (LN) presented at the American Society of Nephrology Kidney Week 2016 on November 19, 2016. The late-breaking abstract presented in the “High Impact Clinical Trials Session”, titled, “AURA-LV: Successful Treatment of Active Lupus Nephritis with Voclosporin,” was presented by principal investigator William Pendergraft, M.D., Ph.D., University of North Carolina Kidney Center.
“There is a critical unmet need for an effective therapeutic treatment of LN, a devastating and life-altering disease that, if left untreated, can lead to end-stage renal disease and even death,” said Dr. Pendergraft. “Until now, the LN clinical trial landscape has been bleak, but AURA is now the first global study in active LN to meet its primary endpoint and all pre-specified secondary endpoints. Voclosporin 23.7mg BID doubled the odds of patients reaching CR in the presence of very low corticosteroid exposure, and maintained normal, stable renal function. Renal function in active LN patients is often erratic, causing concern for clinicians and patients. The observation that renal function in voclosporin-treated patients remained stable throughout the study period is extremely encouraging. Based on the favorable results of the AURA study, I believe voclosporin will help patients who are impacted by this disease.”
The AURA study enrolled 265 patients in 20 countries using low dose (23.7 mg BID) voclosporin, high dose voclosporin (39.5 mg BID) or placebo added to standard of care of mycophenolate mofetil (MMF) and steroids in active LN. The study met its primary endpoint with statistically significant CR rates in the 23.7mg BID arm, and demonstrated statistically significant improvements across all secondary endpoints: Partial Remission (PR); time to CR and PR; reduction in Systemic Lupus Erythematosus Disease Activity Index (SLEDA)I score; and reduction in UPCR over the 24-week treatment period. In the voclosporin arms, the renal function as measured by eGFR was stable and not significantly different from the control arm during the course of the trial. Mean blood pressure was slightly reduced and was similar between all treatment groups. Adverse events occurred in both voclosporin groups (25.8% low, 25.0% high, 15.8% placebo) with the nature of adverse events consistent with those observed in patients with highly active LN and increased immunomodulation. The AURA study remains ongoing until its 48-week secondary endpoints, which will be completed in Q1 2017.
“The nephrology community’s positive reception to the AURA data is encouraging as we prepare to initiate our single Phase III clinical trial of voclosporin in Q2 2017,” said Neil Solomons, M.D., Aurinia’s Chief Medical Officer. “We remain committed to progressing this important therapy to market and believe it has the potential to change the paradigm of care for patients living with LN, significantly improving long-term outcomes and quality of life.”
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