Aurinia Pharmaceuticals has completed the initial analysis of voclosporin in its AURION trial, an open label, single arm, exploratory trial examining patients with active lupus nephritis (LN) taking voclosporin 23.7 mg. twice daily in combination with standard of care, mycophenolate mofetil, and corticosteroids. The study is assessing biomarkers of disease activity at eight weeks and their ability to predict response at 24 and 48 weeks.
Voclosporin is a new class calcineurin inhibitor (CNI) with extensive clinical data in over 2,600 patients in other indications. The drug is made by a modification of a single amino acid of the cyclosporine molecule (a CNI approved for use in transplant patients since 1983), which results in more predictable pharmacokinetics and pharmacodynamics, an increase in potency, an altered metabolic profile, and the potential for flat dosing.
Preliminary data showed that all seven patients treated for a minimum period of eight weeks reached at least a 25 percent reduction in proteinuria (abnormal quantities of protein in urine indicating kidney damage) in comparison to baseline. Furthermore, this reduction was a predictor of a favorable clinical response at 24 weeks. Results also revealed that additional eight-week biomarkers of active lupus nephritis were improved toward normalization, which were also found to be predictors of a favorable clinical response at 24 weeks.
In the initial eight weeks of a 48-week regimen of multitarget therapy including voclosporin, there was a 72 percent reduction of proteinuria, when compared to the levels before therapy. The results further showed that 57 percent of patients achieved complete disease remission (ratio of urinary protein creatinine of less than 0.5mg/mg). Moreover, in these patients, there was a stabilization in the overall renal function (assessed with eGFR).
“We are encouraged by these results. This is the first time voclosporin has been used in this particular patient population,” Neil Solomons, M.D., chief medical officer of Aurinia Pharmaceuticals Inc., said in a news release. “It appears that this data supports our hypothesis that utilizing a multitargeted approach to treating LN with voclosporin can help patients suffering from this disease. We are very excited to see the results from the 265-patient AURA study later this year.”
Aurinia will continue to review the data from the trial and release more data as soon as it becomes available.