“This extraordinary pivotal data confirms voclosporin’s ability to achieve statistically significant improvements in clinically meaningful endpoints for this complex disease, with a comparable safety profile to the current standard of care,” said Neil Solomons, Aurinia’s chief medical officer.
Aurinia’s stock was up 115% after hours after the company announced the results of its pivotal AURORA Phase III trial of voclosporin with mycophenolate and low-dose corticosteroids in lupus nephritis, which is an autoimmune disease related to lupus.
The company, based in Victoria, British Columbia, indicated that the Phase III trial had hit its primary endpoints as well as statistically significant results in all pre-specified hierarchical secondary endpoints. It plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration in the first half of 2020.
“This extraordinary pivotal data confirms voclosporin’s ability to achieve statistically significant improvements in clinically meaningful endpoints for this complex disease, with a comparable safety profile to the current standard of care,” said Neil Solomons, Aurinia’s chief medical officer. “This data represents a significant advance for people living with LN, which can lead to irreversible kidney damage, eventual kidney failure and death.”
Lupus nephritis or LN is an inflammation of the kidney caused by systemic lupus erythematosus (SLE). It is a serious progression of SLE, which is a chronic, complex and often disabling disease. LN has very straightforward outcomes measured by protein in the urine. LN patients have kidney damage, which if uncontrolled, can cause permanent, irreversible damage that could result in end-stage renal disease (ESRD).
Voclosporin is a potentially best-in-class calcineurin inhibitor. By inhibitor calcineurin, it blocks IL-2 expression and T-cell mediated immune responses, which stabilizes the podocyte in the kidney.
In the AURORA study, 357 patients with active LN were enrolled. The trial’s primary endpoint of Renal Response rates was 40.8% for voclosporin compared to 22.5% for the control group. The secondary endpoints included Renal Response at 24 weeks, Partial Renal Response at 24 and 52 weeks, time to achieve urinary protein-to-creatinine ration (UPCR) and time to 40% reduction in UPCR.
The drug was well tolerated with no unusual or unexpected safety signals.
“These data represent a potential game changer for patients suffering from this debilitating disease,” said Brad Rovin, chief, Division of Nephrology and medical director of the Clinical Trials Management Organization at the Ohio State University Wexner Medical Center. “This confirmatory Phase III result represents a clinically meaningful leap forward in the treatment of lupus nephritis. Importantly, the data indicate no excess of adverse events in the voclosporin group compared to patients managed with standard of care alone.”
There was a single patient death in the voclosporin group compared to five in the control arm. A previous study of the drug in LN had a surprisingly high death rate. This study appears to diffuse those concerns.
“We are thrilled with the outcomes reported today from the AURORA trial, which unequivocally demonstrate the tremendous potential for voclosporin to play an important role in the treatment of the approximately one million people worldwide living with LN,” said Peter Greenleaf, president and chief executive officer of Aurinia. “We are aware of the intense need for clinically impactful therapy for this serious disease and are working with urgency to complete regulatory filings in the U.S. and worldwide. If approved, we look forward to potentially making voclosporin available to patients beginning in 2021.”
