Phase 3 Trial of Voclosporin for Lupus Nephritis Completes Study Visits, Results Expected Soon

A Phase 3 trial assessing the potential of voclosporin as an add-on to standard treatment for people with lupus nephritis has completed patient visits.

“With the completion of patient visits in the AURORA study, we now look forward to reporting out the efficacy and safety results by the end of this year,” Neil Solomons, MD, chief medical officer of Aurinia Pharmaceuticals, said in a press release.

Lupus nephritis is a type of kidney inflammation, and one of the most frequent manifestations in people with systemic lupus erythematosus. If not treated, it can cause damage to the kidneys.

Voclosporin, developed by Aurinia, is an investigational immunosuppressant intended to block the activity of the enzyme calcineurin. This prevents immune responses mediated by T-cells, and stabilizes podocytes — specialized kidney cells that participate in blood filtration. The result, researchers believe, is that add-on treatment with voclosporin could improve the outcomes of lupus nephritis patients.

Results from a previous Phase 2b trial, called AURA-LV (NCT02141672), showed that adding voclosporin to standard-of-care therapy eliminated kidney inflammation in twice as many patients compared with standard treatment alone. It also extended the time it took for lupus nephritis to re-emerge. The study also showed that voclosporin was  more effective at treating lupus nephritis than other calcineurin inhibitors.

The international, double-blind Phase 3 AURORA (NCT03021499) study is assessing these effects in a larger population of patients. In total, 358 people with lupus nephritis were randomly selected to receive either voclosporin or a placebo over one year, given with CellCept (mycophenolate mofetil, by Genentech) — the standard of care — and a low-dose steroid treatment.

The trial’s primary goal is to assess whether voclosporin increases complete kidney response rates after one year of treatment. Secondary goals will focus on the speed and duration of the participants’ responses to therapy.

Pending positive results, Aurinia hopes to submit a new drug application (NDA) for voclosporin to the U.S. Food and Drug Administration (FDA) by 2020.

After completing the study, eligible participants may enroll in a two-year extension study known as AURORA II. This study is progressing as planned, Aurinia said. Although the results are not required for FDA approval, AURORA II will help assess the long-term safety and efficacy of voclosporin.

“I am extremely grateful for the team’s dedication and commitment as we now work towards database lock, data review, disclosure of the results, followed by the necessary preparations to submit an NDA for voclosporin during the first half of 2020,” Solomons said.

The company also reported that it has completed the sale of 2.3 million common shares for gross proceeds of approximately $15 million.

“This is an extraordinarily exciting time at Aurinia as we await the results from AURORA, and in parallel, build and prepare the organization by ensuring that we are strategically, operationally, and financially prepared for positive results and the planned NDA submission for voclosporin as a first-line treatment in combination with standard of care for LN [lupus nephritis],” said Peter Greenleaf, Aurinia’s president and CEO.