Aurinia posts positive Phase 2b voclosporin results
Aurinia Pharmaceuticals’ (NASDAQ:AUPH; TSX:AUP) voclosporin achieved its primary endpoint of complete remission (CR) at 24 weeks in a Phase 2b trial.
In addition, when both doses of voclosporin were added to the current standard of care of mycophenolate mofetil and a forced oral corticosteroid taper, voclosporin met all 24-week prespecified secondary endpoints versus the control group.
These pre-specified endpoints include: partial remission (PR), time to CR and PR, reduction in systemic lupus erythematosus disease activity index and reduction in urine protein/creatinine ratio over the 24-week treatment period.
The AURA-LV study remains ongoing to its 48-week endpoint when similar and additional secondary analysis will be analyzed 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," Charles Rowland, CEO, said in a statement.
"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," he added.
Dr. William Pendergraft, a principal investigator in the study, said 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," he added.