Aurinia Pharmaceuticals Inc (NASDAQ:AUPH) presented new duration of remission data from its global Phase IIB AURA-LV (AURA) study in lupus nephritis (LN) during the Annual European Congress of Rheumatology (EULAR) 2017 in Madrid, Spain. The presentation was made during the late-breaking session by Prof. Vladimir A. Dobronravov, MD, PhD, DSc, a clinical investigator for the study and Vice Director, Research Institute of Nephrology, 1st St-Petersburg Pavlov State Medical University.
As previously reported, treatment with low dose voclosporin showed statistically improved efficacy over the control arm at both 24 and 48 weeks, with a doubling of remission rates at 48 weeks versus the control arm (49% vs 24%). These results were achieved in the presence of low doses of corticosteroids and normal, stable renal function. Furthermore, of the low-dose voclosporin patients that achieved CR at 24 weeks, 100% remained in CR at 48 weeks, establishing durability of clinical response. The data presented at EULAR 2017 demonstrated that over the course of the 48-week trial, patients on voclosporin stayed in remission approximately twice the amount of time as those in the control group. These differences were statistically significant versus the control arm. Duration of remission as measured by proteinuria is clinically meaningful as it may correlate with lower rates of progression to Chronic Kidney Disease.
The remission results at 48 weeks are summarized below.
“Not only have more patients on voclosporin achieved complete remission, but they have done so faster. Patients on low-dose voclosporin are also maintaining remission for a longer duration—nearly twice that of the control group on average,” stated Dr. Dobronravov. “The quicker we can bring patients into remission and keep them there, the more likely we are to delay or even prevent the deleterious effects of prolonged inflammation which can lead to irreversible kidney damage.”
All arms of the study included the current standard of care of mycophenolate mofetil (MMF) as background therapy and an aggressive steroid taper. Both doses of voclosporin at 48 weeks demonstrated continued improvement over the control group across multiple measures. The voclosporin treated groups demonstrated statistically significant improvement over the control group in speed and rates of complete and partial remission (CR and PR, respectively). Proteinuria levels and reduction in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) scores, which include non-renal measures of lupus activity, also continued to significantly improve over time versus the control group. Additional analyses are ongoing and will be presented at future medical and scientific meetings.
No unexpected safety signals nor adverse events were observed and voclosporin was generally well-tolerated, consistent with what is expected of patients suffering from active LN while undergoing immunomodulation-based therapy. In the voclosporin arms, renal function as measured by estimated glomerular filtration rate (eGFR) was stable and not significantly different from the control arm following the 48-week treatment period. There were no electrolyte changes in the treatment groups and mean blood pressure was also similar across treatment groups through 48 weeks.
Shares of Aurinia Pharmaceuticals are up nearly 6% to $6.29 in pre-market trading Friday. 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 $6.77 and its 200-day moving average is $5.11.
On the ratings front, Aurinia has been the subject of a number of recent research reports. In a report issued on June 5, Cantor analyst Elemer Piros reiterated a Buy rating on AUPH, with a price target of $14, which implies an upside of 136% from current levels. Separately, on May 18, H.C. Wainwright’s Ed Arce reiterated a Buy rating on the stock and has a price target of $10.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Elemer Piros and Ed Arce have a yearly average loss of 6.4% and a return of 21.2% respectively. Piros has a success rate of 36% and is ranked #4292 out of 4569 analysts, while Arce has a success rate of 46% and is ranked #208.
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.