Aurinia Pharmaceuticals announced that seven of the 10 patients with lupus nephritis (LN) enrolled in its AURION study, evaluating short-term predictors of clinical response to voclosporin treatment, achieved complete disease remission at 24 weeks. In addition, the company reported that patients who achieved remission at eight weeks continued in remission at 24 weeks.
Robert Huizinga, Aurinia’s vice president of Clinical Affairs, presented the results at the 10th Annual European Lupus Meeting held in Venice, Italy, Oct. 5–8.
Voclosporin is an investigational immunosuppressant that inhibits an enzyme called calcineurin, which activates immune T-cells. The drug has a synergistic and dual mechanism of action that can potentially improve near- and long-term outcomes in LN when added to standard of care.
AURION (“Aurinia Early Urinary Protein Reduction Predicts Response Study”) is an open-label, single arm, exploratory trial examining 10 active LN patients being given voclosporin, 23.7 mg twice daily, in combination with standard of care, namely mycophenolate mofetil and corticosteroids. The study, being conducted at different sites in Malaysia, is assessing biomarkers of disease activity at eight weeks and their ability to predict response at 24 and 48 weeks.
The 24-week data showed that 7 out of the 10 patients achieved complete disease remission, as assessed by a urinary protein creatinine ratio (UPCR) equal or less than 0.5 mg/mg, eGFR (estimated glomerular filtration rate; a measure of how well the kidneys are working) within 20% of baseline, and a concomitant steroid dose of less than 5 mg/day.
In addition, of the 10 patients who achieved at least a 25 percent reduction in proteinuria (abnormal quantities of protein in urine, indicating kidney damage) at eight weeks, eight attained partial remission (at least 50 percent reduction in proteinuria over baseline) at 24 weeks.
Results also revealed that inflammatory biomarkers of active LN, including C3, C4 and anti-dsDNA, continued to normalize. At eight weeks, these biomarkers improved toward normalization, and were considered predictors of a favorable clinical response at 24 weeks. There were no safety issues reported and voclosporin was found to be well-tolerated.
“The results of AURION provide further proof of concept data to support voclosporin’s use in the treatment of active LN and continue to indicate that 23.7 mg BID is the optimal dose to advance into our phase III program,” Neil Solomons, MD, chief medical officer of Aurinia, said in a press release. “We are encouraged by our ability to quickly predict responses and remission rates in these patients, which can help clinicians optimize patient care and long-term outcomes.”
Aurinia recently reported that its AURA-LV Phase 2 study (NCT02141672) also met its primary endpoint — at week 24, patients with LN achieved complete remission at the lowest dose of voclosporin (23.7 mg).
Taken together, the results suggest that voclosporin can improve remission rates in patient with LN.