Aurinia Pharmaceuticals (NASDAQ:AUPH; TSX:AUP) plans to initiate a single Phase 3 clinical trial (Aurora), with a design consistent with that of the continuing Aura-LV clinical trial of voclosporin for the treatment of lupus nephritis (LN).
Data from both the Aurora and Aura trials will serve as the basis for a new drug application submission following completion of the Phase 3 trial.
The company continues to focus its efforts on finalizing the study protocol and regulatory submissions in parallel with site selection, making the necessary investments now to ensure the team has the tools to execute a successful clinical trial.
Aurinia recently released statistically significant data from the Aura study, demonstrating significantly improved long-term outcomes for patients suffering from LN.
In a statement, Richard Glickman, chairman and CEO, said recent news that our late-breaking abstract for voclosporin has been accepted for oral presentation at the National Kidney Foundation 2017 Scientific Clinical Meetings “underscores the importance of this compelling dataset.”
He said the company remains committed to advancing voclosporin, with the end goal of improving the lives of patients impacted by this devastating disease, and potentially altering the treatment paradigm of lupus nephritis.