Aurinia Pharmaceuticals (AUPH) Says Voclosporin Achieves Primary, Secondary Endpoints in Phase IIb Study for LN
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Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (TSX:AUP) (“Aurinia” or the “Company”) a clinical stage biopharmaceutical company focused on the global immunology market, today announced that in addition to voclosporin (23.7 mg BID) achieving its primary endpoint of Complete Remission (CR) at 24 weeks, both doses of voclosporin when added to the current standard of care of Mycophenolate Mofetil (MMF) and a forced oral corticosteroid taper have met all 24-week pre-specified secondary endpoints vs the control group. These pre-specified endpoints include: Partial Remission (PR), which is measured by a ≥50% reduction in UPCR with no concomitant use of rescue medication; time to CR and PR; reduction in Systemic Lupus Erythematosus Disease Activity Index or SLEDAI score; and reduction in UPCR over the 24-week treatment period.
|Pre-specified Secondary Endpoint||Control||Low Dose VCS|
|High Dose VCS|
|Time to Complete Remission (TTCR) [median]||Not achieved||19.7 weeks||23.4 weeks|
|Partial Remission (as measured by UPCR reduction of ≥ 50% from baseline)||49%||70%||66%|
|Time to Partial Remission (TTPR) [median]||6.6 weeks||4.1 weeks||4.4 weeks|
|Reduction in UPCR||-2.216 mg/mg||-3.769 mg/mg||-2.792 mg/mg|
All p-values are vs control
The AURA-LV study remains ongoing to its 48-week endpoint upon which similar and additional secondary analysis will be analysed and presented early next year.
“We are thrilled by the results of the AURA study and voclosporin’s potential to shift the treatment paradigm for active lupus nephritis,” said Charles Rowland, CEO of Aurinia. “The ability to get more patients into remission and in a shorter period time than the current standard of care can have a significant impact on the long-term outcomes for these patients.”
“LN is a serious and devastating disease that can severely impact a patient’s life,” said William Pendergraft, MD, PhD, Assistant Professor of Medicine in the Division of Nephrology & Hypertension, at the University of North Carolina and a Principal Investigator in the study. “Voclosporin has demonstrated it can nearly double the number of patients that achieve Complete Remission in the presence of very low corticosteroid exposure. Based on these data, I believe this drug has the potential to significantly improve the long-term prognosis of my patients afflicted with LN and could become an integral component of the standard of care.”
The Company will present the full efficacy (including pre-specified and ad hoc sub-analyses) and comprehensive safety data during a webcast presentation to be held at 8:00am ET. A link to the live webcast and slides will be available on the Investors section of the Company’s website at http://www.auriniapharma.com.
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