Aurinia’s drug for autoimmune kidney disease hits goals in late-stage trial
Aurinia Pharmaceuticals (AUPH) said Wednesday evening that an experimental medicine used to treat patients with lupus nephritis, an autoimmune kidney disease, achieved all primary and secondary efficacy goals in a late-stage clinical trial.
The drugmaker, headquartered near Vancouver, Canada, expects to submit a marketing application to the U.S. Food and Drug Administration in the first half of next year.
Aurinia’s stock price more than doubled in value to $17.30 per share in after-hours trading.
Lupus nephritis is a chronic disease (and a form of lupus) in which a person’s own immune system attacks the kidneys, causing inflammation that progressively destroys kidney function. There are no drugs approved today specifically to treat lupus nephritis, so doctors use a combination of immunosuppressive drugs and steroids with mixed results.
In the Phase 3 clinical trial, the Aurinia drug, called voclosporin, demonstrated a kidney response rate of 41% after one year compared to a response rate of 22.5% in the control arm — achieving the primary endpoint with statistical significance. The clinical trial enrolled 357 patients with active lupus nephritis, randomized to receive either voclosporin or a placebo given on top of standard immunosuppressive drugs.
There was one death reported in the voclosporin arm compared to five deaths in the control arm. The low mortality rate favoring voclosporin should eliminate safety fears that had weighed on the drug’s future. A previously conducted study of voclosporin in lupus nephritis patients was marred by a surprisingly high death rate.
Overall, the rate of serious adverse events reported by patients was equal in both the voclosporin and control arms.
“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 lupus nephritis,” said Aurinia chief executive Peter Greenleaf, in a statement.