Aurinia Pharmaceuticals Inc (NASDAQ:AUPH) announced top-line results from its Phase IIb AURA-LV (AURA) study in lupus nephritis (LN). At 48 weeks, the trial met the complete and partial remission (“CR”/ “PR”) endpoints, demonstrating statistically significantly greater CR and PR in patients in both low dose (23.7mg of voclosporin twice daily (p<.001)) and high dose (39.5mg twice daily (p=.026)) cohorts versus the control group.
Each arm of the study included the current standard of care of mycophenolate mofetil (MMF) as background therapy and a forced steroid taper to 5mg/day by week 8 and 2.5mg by week 16. No unexpected safety signals were observed and there were no additional deaths in the voclosporin treated patients; however, there were three deaths and one malignancy reported in the control arm after completion of the study treatment period. Additional data analyses for the AURA study at 48 weeks will be released at future corporate, medical and scientific meetings.
“Lupus nephritis (LN) is one of the most severe complications of systemic lupus erythematosus. The current treatments of LN are toxic and the complete renal response rates are unacceptably low. For the last several years the community of lupus researchers in collaboration with the pharmaceutical industry have been engaged in finding more effective therapies for LN, but success has been difficult to achieve,” said Brad Rovin, MD, FASN, Director of Nephrology and Vice Chairman of Research for the Department of Internal Medicine at the Ohio State University Wexner Medical Center. “The AURA trial’s long-term results convincingly demonstrate that the addition of voclosporin to standard of care treatment is superior to standard of care alone. These data are not only statistically significant, but clinically important. Twice as many patients given 23.7mg voclosporin twice daily achieved a complete renal response compared to those treated with placebo. This is an impressive renal response rate and these results may shift the treatment paradigm of LN. Based on these encouraging data, I am looking forward to the Phase III trial of voclosporin in LN.”
The 24 and 48-week top-line efficacy results are summarized below:
“We are grateful to both the patients and investigators who have worked with us on this groundbreaking program. Voclosporin is the first and only treatment candidate that has demonstrated such a clear treatment effect for LN patients,” said Neil Solomons, MD, Aurinia’s Chief Medical Officer. “These data provide us with tremendous confidence that we can execute a successful Phase III program and make a meaningful impact on patients’ lives.”
“Lupus nephritis carries with it life-threatening complications, including kidney failure. The treatment of the disease is challenging, and steroid side-effects are often difficult for patients to endure. The National Kidney Foundation supports the development of steroid-sparing treatment options, and we look forward to following the results of the Phase III trial,” said Joseph Vassalotti, MD, Chief Medical Officer, National Kidney Foundation.
Shares of Aurinia closed today at $3.71, up $0.15 or 4.21%. AUPH has a 1-year high of $5.69 and a 1-year low of $1.74. The stock’s 50-day moving average is $3.12 and its 200-day moving average is $2.89.
On the ratings front, AUPH has been the subject of a number of recent research reports. In a report issued on February 14, FBR analyst Vernon Bernardino reiterated a Buy rating on AUPH, with a price target of $9.00, which implies an upside of 148% from current levels. On February 7, H.C. Wainwright’s Ed Arce reiterated a Buy rating on the stock and has a price target of $8.00.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Vernon Bernardino and Ed Arce have a yearly average loss of 15.3% and a return of 21.0% respectively. Bernardino has a success rate of 27% and is ranked #4425 out of 4503 analysts, while Arce has a success rate of 48% and is ranked #197.
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.