Aurinia Pharmaceuticals Inc (NASDAQ:AUPH) announced additional 48-week results from its global Phase IIb AURA-LV (AURA) study in lupus nephritis (LN) during the National Kidney Foundation 2017 Spring Clinical Meetings in Orlando, FL. In addition to the trial meeting its complete and partial remission (“CR”/”PR”) endpoints at 48 weeks, all pre-specified secondary endpoints that have been analyzed to date were also met at 48 weeks. These pre-specified endpoints include: time to CR and PR (speed of remission); reduction in Systemic Lupus Erythematosus Disease Activity Index or SLEDAI score; and reduction in urine protein creatinine ratio (UPCR) over the 48-week treatment period. The data were presented during the late-breaking session by lead author Dr. Samir Parikh, a clinical investigator for the study and Assistant Professor of Clinical Nephrology at the Ohio State University.
Each arm of the study included the current standard of care of mycophenolate mofetil (MMF) as background therapy and a forced steroid taper. Both doses of voclosporin at 48 weeks demonstrated continued improvement over the control group across multiple dimensions. Notably, the voclosporin groups demonstrated statistically significantly improved speed and rates of CR and PR. Of the patients that achieved CR at 24 weeks, in the low-dose voclosporin group, 100% remained in CR at 48 weeks, which demonstrates durability of clinical response. Proteinuria levels and reduction in SLEDAI scores, which include non-renal measures of lupus activity, also continued to significantly separate over time versus the control group. Additional analyses are ongoing and will be presented at future medical and scientific meetings.
No unexpected safety signals were observed and voclosporin was generally well-tolerated, with the nature of adverse events consistent with what is expected of patients suffering from highly active LN while undergoing immunomodulation-based therapy. In the voclosporin arms, the renal function as measured by eGFR was stable and not significantly different from the control arm during the 48-week treatment period. Mean blood pressure was also similar between all treatment groups.
“The most exciting aspect of this data is that voclosporin is the first treatment candidate to successfully meet all of its clinical endpoints in a global, prospective LN trial,” said Dr. Samir Parikh, a clinical investigator for the study and Assistant Professor, Clinical Nephrology at the Ohio State University. “Voclosporin, when added to standard of care, achieved the highest complete remission rate of any global, active LN trial, and this was accomplished with extremely low-dose steroid exposure. The possibility of achieving a better clinical response while avoiding the significant side effects associated with prolonged exposure to high dose steroids has the potential to be a game-changer in the management of LN.”
“We are pleased by the recognition of the medical and scientific communities of the AURA study results. Beyond the remission rates we’ve shown with voclosporin, the significant improvement in SLEDAI scores points towards a durable, immunological effect on a broad range of clinically meaningful lupus outcomes,” said Neil Solomons, MD, Aurinia’s Chief Medical Officer. “This data provides us with tremendous confidence that we can execute a successful Phase III program and make a meaningful impact on patients’ lives.”
Shares of Aurinia are up nearly 6% to $7.43 in after-hours trading Thursday. AUPH has a 1-year high of $10.54 and a 1-year low of $1.74. The stock’s 50-day moving average is $7.19 and its 200-day moving average is $4.17.
On the ratings front, AUPH has been the subject of a number of recent research reports. In a report issued on April 10, Cantor analyst Elemer Piros initiated coverage with a Buy rating on AUPH and a price target of $14.00, which implies an upside of 100% from current levels. On April 7, FBR’s Vernon Bernardino reiterated a Buy rating on the stock and has a price target of $11.00.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Elemer Piros and Vernon Bernardino have a yearly average loss of 3.2% and 8.4% respectively. Piros has a success rate of 45% and is ranked #3967 out of 4559 analysts, while Bernardino has a success rate of 28% and is ranked #4451.
Overall, 4 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $12.00 which is 71% above where the stock opened today.
Aurinia Pharmaceuticals, Inc. operates as a biopharmaceutical company. It focuses on discovering and developing immunomodulating therapeutics. The company’s pipeline includes voclosporin for the treatment of lupus nephritis.