Aurinia Pharmaceuticals will take its drug candidate voclosporin into a possibly pivotal Phase 3 clinical trial of its efficacy in treating lupus nephritis — kidney disease caused by systemic lupus erythematosus.
Following Phase 2 study meetings with the U.S. Food and Drug Administration (FDA), Aurinia believes the new trial will provide the data necessary to support a new drug application for voclosporin.
The drug blocks an immune molecule known as calcineurin, and — in contrast to earlier drugs acting on the same target — has a good safety profile. To date, voclosporin has been tested in more than 2,000 patients with various diseases.
“We are thrilled with the outcome and direction received from the FDA. With a clear path forward for voclosporin’s development to treat lupus nephritis, we are mobilizing quickly to initiate the Phase III study … fulfilling our goal of improving the long-term outcomes for patients with this disease,” Charles Rowland, Aurinia’s Chief Executive Officer, said in a press release.
The planned trial, called AURORA, will run for 52 weeks at multiple locations worldwide. Patients will be randomized to receive either 23.7 mg voclosporin plus CellCept (mycophenolate mofetil), a standard of care treatment, or placebo and CellCept, in a blinded fashion. The study will enroll about 320 patients, and is planned to start mid-2017.
Response to treatment will be evaluated using a set of kidney analyses. Patients who complete the study will be offered to remain for a 104-week blinded continuation study, assessing long-term outcomes.
While voclosporin has received Fast Track designation — a status speeding up the development and review of a drug — the FDA has made it clear that voclosporin is not eligible for breakthrough therapy designation at this time, a step that would provide even further benefits in the drug development process.
“We have shared a substantial amount of efficacy and safety data with the FDA and are confident in our ability to execute a successful Phase III clinical trial based on their feedback and the information gleaned from the AURA study,” said Lawrence D. Mandt, vice president of Quality and Regulatory Affairs at Aurinia.
“We remain committed to addressing the unmet needs of patients living with lupus nephritis, a devastating disease, and look forward to making this product available to patients as soon as possible.”