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news.A phase 2b clinical trial assessing Aurinia Pharmaceuticals’ Voclosporin met its primary efficacy endpoint in patients with active lupus nephritis (LN), an inflammation of the kidney caused by the autoimmune disorder systemic lupus erythematosus (SLE).
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The Phase 2b AURA-LV study compared the efficacy of voclosporin added to current standard-of-care therapy mycophenolate mofetil against placebo plus CellCept in achieving complete remission (CR) in 265 patients with active LN.
Participants were randomized to receive one of two dosages of voclosporin (23.7 mg or 39.5 mg twice daily) or placebo.
It demonstrated statistically significantly greater CR 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 at 24 weeks (p=0.007; p=0.024).
The company intends to meet with the US Food and Drug Administration in the fourth quarter of this year to discuss the results and clarify a regulatory path to approval.
Further analyses of the data will be released later this year and will be submitted for presentation at a future medical conference.
The study will continue through 48 weeks and the data will be unveiled in early 2017.
Voclosporin is a novel calcineurin inhibitor and an immunosuppressant, with a synergistic and dual mechanism of action that has the potential to enhance near- and long-term outcomes in LN when added to standard of care.
It inhibits calcineurin to block IL-2 expression and T-cell mediated immune responses.
Image: High magnification micrograph of diffuse proliferative lupus nephritis, class IV. Photo: courtesy of Nephron.