Aurinia Pharmaceuticals recently released an analysis of the first seven patients to complete 24 weeks in its open-label, exploratory AURION clinical trial to access the short-term predictors of response using voclosporin in combination with mycophenolate mofetil and oral corticosteroids in patients with active lupus nephritis (LN).
At 24 weeks, 57 percent of LN patients on the therapy remained in complete remission.
The results demonstrated in the seven patients, a mean reduction of 54 percent in proteinuria compared to pre-treatment levels along with consistent improvements in C3, C4 and anti-DS DNA. Renal function (eGFR) remained stable and without safety signals.
Kidney Inflammation caused by systemic lupus erythematosus (SLE) is called lupus nephritis (LN). It is estimated that approximately 40-50 percent of all SLE patients have clinical LN requiring treatment.
In patients with LN, renal damage results in proteinuria and, or hematuria and a decrease in renal function as evidenced by reduced eGFR, and increased serum creatinine levels. Poorly controlled LN can lead to permanent and irreversible tissue damage within the kidney, resulting in end-stage renal disease, which makes LN a serious and potentially life-threatening condition.
The remission criteria in AURION (Aurinia early Urinary protein Reduction Predicts Response) was similar to that of the Aurinia’s AURA clinical trial, an adequate and well controlled trial that completed enrollment of 265 patients in January 2016. Results of AURA are expected later this summer.
“It appears that these data continue to support the hypothesis that biomarkers at 8 weeks can potentially predict renal response at 24 weeks,” said Dr. Neil Solomons, chief medical officer of Aurinia in a recent press release. “We’re seeing a reduction in disease activity that is consistent across the biomarker panel.”
Aurinia’s CEO Charles Rowland said the results are encouraging.
“If the AURION data is reproduced in the AURA study it may lead to a paradigm shift in the treatment of LN patients in that voclosporin in combination with Mycophenolate Mofetil and low dose steroids can be used to achieve higher rates of complete remission than existing treatment approaches,” Rowland said.
The remission was measured by a urinary protein creatinine ratio of less than or equal to 0.5mg/mg, eGFR within 20 percent of baseline and concomitant steroid dose of less than 5mg/day.
Aurinia will continue to review the AURION’s results and release more data as it becomes available.
Lupuzor (rigerimod), previously known as IPP-201101 or P140, has a novel mechanism of action aimed at modulating the body’s immune system so it will not attack healthy cells, with no associated adverse side effects. Its benefits include the possibility of halting disease progression in many patients.