Shares of Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) saw a handy gain on Wednesday after the company gave an update on its lupus nephritis (LN) treatment. Specifically, the company highlighted additional findings from its global Phase 2b AURA study of voclosporin in LN. The abstract was presented at the American College of Rheumatology and Association of Rheumatology Health Professionals Annual Meeting in Washington, D.C.
Keep in mind that this is the first global active LN study to meet its primary endpoint. In addition, all secondary endpoints in AURA were met, including demonstrating a more rapid response rate for patients receiving voclosporin versus patients in the control arm with most patients achieving complete remission (CR) at or before the eighth week of the trial.
The AURA study enrolled 265 patients in 20 countries using low (23.7 mg BID), high dose voclosporin (39.5 mg BID) or placebo added to standard of care of mycophenolate mofetil and steroids in active LN. The study met its primary endpoint with statistically significant complete remission rates in the 23.7mg BID arm, and demonstrated statistically significant improvements across all secondary endpoints: Partial Remission (PR); time to CR and PR; reduction in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score; and reduction in UPCR over the 24-week treatment period.
Adverse events were higher in the voclosporin treatment arms versus the control arm, which is consistent with increased immunosuppression. The overall mortality rate was similar to other recent global LN trials.
Based on recent FDA feedback, Aurinia expects to initiate a single Phase 3 clinical trial of voclosporin in the second quarter of 2017.
Dr. Mary Anne Dooley, M.D., MPH, of the University of North Carolina Kidney Center, commented:
Lupus nephritis is a devastating, often overlooked disease that severely impacts a patient’s quality of life and, in the worst cases, can lead to end-stage renal disease or even death,” “The ability to get more patients into remission and in a shorter period of time than the current standard of care can have a significant impact on the long-term outcomes for these patients. We have demonstrated that voclosporin successfully achieves not only higher complete remission rates but does so more rapidly in patients with LN. I believe this promising data has the potential to shift the standard of care and improve long-term outcomes for patients with LN.
Shares of Aurinia were last seen up 7% at $4.13 on Wednesday, with a consensus analyst price target of $8.90 and a 52-week trading range of $1.42 to $5.69.