Aurinia Pharmaceuticals Inc (NASDAQ:AUPH) announced the 48-week results from the “Aurinia Early Urinary Protein Reduction Predicts Response Study” (AURION) open-label study of voclosporin for the treatment of lupus nephritis (LN) at the 12th International Congress on Systemic Lupus Erythematosus and 7th Asian Congress on Autoimmunity jointly in Melbourne, Australia. The data were presented by Robert B. Huizinga, Vice President of Clinical Affairs at Aurinia.
The study successfully achieved its primary objective by demonstrating that early biomarker response in active LN patients can be a significant predictor of renal response at 24 and 48 weeks.
In the per protocol analysis at 48 weeks, 71% of subjects (n=5/7) on treatment remain in complete remission as measured by a urinary protein creatinine ratio (UPCR) of ≤ 0.5mg/mg, eGFR within 20% of baseline and concomitant steroid dose of <5mg/day. A 25% reduction in UPCR at week eight was found to be highly predictive of achieving renal response at 24 and 48 weeks. Conversely, if C3 and C4 do not normalize by week 8, then a renal response at week 24 and 48 is highly unlikely. Anti-dsDNA was not found to be a useful biomarker in predicting long-term response in LN patients.
No new safety signals were observed with the use of voclosporin in LN patients; voclosporin was well-tolerated, and the safety profile was consistent with other immunomodulators. A total of three subjects were discontinued prior to 48 weeks due to lupus related complications or Investigator discretion.
“Results from AURION demonstrated that an early UPCR reduction of 25% is the best predictor of renal response at 24 and 48 weeks,” said Neil Solomons, MD, Chief Medical Officer at Aurinia. “In addition, the use of C3 or C4 improves the precision of predicting if a patient will achieve a clinical response. This exploratory study is supportive of the successful AURA Phase 2b study and continues to inform us of optimal ways to evaluate renal response in future LN trials.”
Shares of Aurinia are up nearly 3% to $8.23 in pre-market trading Monday. 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 $5.55 and its 200-day moving average is $3.58.
On the ratings front, Aurinia has been the subject of a number of recent research reports. In a report issued on March 22, FBR analyst Vernon Bernardino reiterated a Buy rating on AUPH, with a price target of $11, which represents a potential upside of 37% from where the stock is currently trading. Separately, on March 10, Canaccord Genuity’s John Newman 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, Vernon Bernardino and John Newman have a yearly average loss of 8.3% and 6.5% respectively. Bernardino has a success rate of 27% and is ranked #4440 out of 4554 analysts, while Newman has a success rate of 38% and is ranked #4430.
Aurinia Pharmaceuticals, Inc. operates as a biopharmaceutical company. It focuses on discovery and development of immunomodulating therapeutics. Its products include voclosporin and non-immunosuppressive cyclosporine analogue molecules for the treatment of lupus nephritis.