Aurinia Pharmaceuticals (AUPH) Announces Significant Data from Phase 2b AURA-LV in LN

August 15, 2016 6:08 AM EDT
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Aurinia Pharmaceuticals (NASDAQ: AUPH) announced positive top-line results from the Phase 2b AURA-LV (AURA) clinical study in patients with active lupus nephritis (LN). The trial achieved its primary endpoint, demonstrating statistically significantly greater complete remission (CR) (as defined by confirmed urinary protein/creatinine ratio of ≤0.5 mg/mg at 24 weeks and confirmed at 26 weeks) in patients treated with 23.7 mg of voclosporin twice daily (p=0.045). Both treatment arms, 23.7 mg and 35.9 mg twice daily also showed a statistically significant improvement in the rate of achieving partial remission (PR) at 24 weeks (p=0.007; p=0.024). Each arm of the study included the current standard of care of mycophenolate mofetil (MMF) as background therapy and a forced steroid taper to 5 mg/day by week 8 and 2.5 mg by week 16. No unexpected safety signals were observed and voclosporin was shown to be well tolerated.

“We are very pleased by these encouraging results and are grateful to those that participated in our clinical trials,” said Neil Solomons, M.D., Aurinia’s Chief Medical Officer. “The AURA study was conducted under rigorous and stringent criteria, enhancing our confidence in voclosporin’s potential ability to provide a substantial improvement over the currently accepted standard of care, especially given that study participants had such active disease and were exposed to such a low corticosteroid load. We continue to work diligently towards our goal of improving long-term outcomes for these patients.”

Based on the results of the 24-week analysis, Aurinia plans to meet with the U.S. Food and Drug Administration in the fourth quarter of 2016 to discuss these data and the drug’s subsequent clinical development and path to registration in LN. Further analyses of the data will also be conducted and will be released later this year. Additionally, the Company plans to submit the results for presentation at a major medical meeting in the near future. The study will continue through 48 weeks, and these data will be available for release in early 2017.

Mary Anne Dooley, M.D., a rheumatologist, LN expert and Chief Investigator on the study, stated “These preliminary results show great promise and could potentially change the current treatment paradigm for LN. The remission rates show a meaningful improvement over the current standard of care. Achieving this result given the taper to low dose steroids represents a significant advance. Given the side effects of corticosteroids, limiting the dose could substantially enhance a patient’s quality of life.”

“The results of this trial are welcomed and exciting news for people with lupus and their doctors who are eager to have more tolerable and effective treatments options," said Sandra. C. Raymond, President and Chief Executive Officer of the Lupus Foundation of America. “Lupus kidney disease (lupus nephritis) is one of the most serious and potentially life-threatening complications of this autoimmune disease, affecting as many as 60 percent of people with lupus. This trial of voclosporin along with standard of care is the first trial of a potential treatment for active lupus nephritis to reach its primary endpoint, offering hope to individuals with lupus kidney disease. We look forward to the timely commencement of a Phase 3 trial; and, should the findings confirm this study, the addition of this regimen to the arsenal of treatments available to people who have waited far too long for medicines that improve the quality of their lives.”

Conference Call and Webcast Details

Aurinia will host a conference call and webcast today, August 15, 2016 at 8:00 a.m. Eastern Daylight Time to discuss the AURA-LV study results. In order to participate in the conference call, please dial +1-877-407-9170 (Toll-free US & Canada). An audio webcast can be accessed under "Webcasts" through the “Investors” section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website for 45 days.



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