Canada’s Aurinia Pharmaceuticals is one step closer to releasing voclosporin — a new drug now being developed to treat active lupus nephritis (LN).
In a press release, Aurinia announced plans for a Phase 3 clinical trial (AURORA; NCT03021499). Along with ongoing discussions with both the European Medicines Agency (EMA) and Japan’s Pharmaceutical and Medical Devices Agency, the company believes data provided by the study will offer a clear path towards regulatory submission in the United States, the 28-member European Union and Japan.
LN, an inflammatory disease that causes kidney damage, can result in end-stage renal disease if not treated. Voclosporin, a novel immunosuppressant, has already shown promise in a 48-week, Phase 2 clinical study (AURA-LV, NCT02141672). Voclosporin modifies cytokine activity as well as T-cell mediated immune response with the potential to improve both short-term and long-term outcomes in LN, according to researchers.
The proposed AURORA Phase 3 clinical trial is a 52-week, double-blind, placebo-controlled study that will compare the effects of voclosporin when added to the current standard of care, mycophenolate mofetil (CellCept). The study will involve about 320 patients with biopsy-proven active LN and will assess the renal response in patients with active LN; a composite diagnosis based on several criteria including improved urinary-protein to creatinine ratios, stable renal function and sustained, low-dose steroid use without the need for rescue medications.
Aurinia believes that current discussions with regulatory bodies — in conjunction with the data acquired from AURORA and AURA-LV — will support regulatory submission.
“Our interactions with regulators in all three jurisdictions have given us a clear pathway for Phase III, and we are confident in our ability to execute AURORA successfully based on their feedback and the information gleaned from the AURA study,” said Lawrence D. Mandt, Aurinia’s vice-president of quality and regulatory affairs. “The productive conclusion of these regulatory interactions marks a milestone in our development program and brings this exciting new therapeutic option one step closer to those patients suffering from LN.”
The company anticipates that upon regulatory approval, patent protection for voclosporin will be extended in the United States, Europe and Japan until at least October 2027
Added Aurinia CEO Richard M. Glickman: “We are on track to initiating the global AURORA study this quarter and fulfilling our goal of improving the long-term outcomes for patients with this disease.”