Canadian-based clinical stage bio-pharmaceutical company Aurinia has reported positive results from its AURA–LV study of voclosporin in combination with mycophenolate mofetil against placebo to treat lupus nephritis (LN).
Voclosporin is an investigational, calcineurin inhibitor blocking the IL-2 expression and T-cell mediated immune responses.
It is developed by a modification of a single amino acid of the cyclosporine molecule that has exhibited predictable pharmacokinetic and pharmacodynamic relationship, an increase in potency, an altered metabolic profile, and potential for flat dosing.
Voclosporin works as an immunosuppressant, with a synergistic and dual mechanism of action that can improve near and long-term outcomes in LN when added to standard of care (MMF).
The Aurinia Urine Protein Reduction in Active Lupus Nephritis Study (AURA–LV) is intended to evaluate the efficacy of voclosporin combined with the current standard of care called mycophenolate mofetil (MMF, also known as CellCept) against placebo.
The study was primarily focused on achieving a complete remission (CR) of LN.
It comprised of two arms and enrolled 265 patients who were administered with low doses of corticosteroids as background therapy.
After 24 weeks, data suggested that both doses of voclosporin added to (MMF) and a forced oral corticosteroid taper have met all the pre-specified secondary endpoints that were achieving partial remission (PR), time to CR and PR, reduction in systemic lupus erythematosus disease activity index and reduction in UPCR over the 24-week treatment period.
University of North Carolina division of nephrology and hypertension assistant professor of medicine and principal investigator of study William Pendergraft said: “LN is a serious and devastating disease that can severely impact a patient’s life.
“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 this 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 AURA-LV study is proceeding towards its 48-week endpoint and an additional secondary analysis is expected early next year.
Image: Micrograph displaying class IV lupus nephritis. Photo: courtesy of Nephron.