Aurinia Pharmaceuticals’ product candidate voclosporin continues to show promise in patients with lupus nephritis (LN), according to the company.
In addition to meeting complete and partial remission endpoints at 48 weeks of the trial, treatment with voclosporin also met secondary endpoints, such as reduction in speed of remission, disease activity, and urine protein creatinine ratio (UPCR) over the same period.
These data were presented at the National Kidney Foundation 2017 Spring Clinical Meetings in Orlando by study’s author, Samir Parikh.
“The most exciting aspect of this data is that voclosporin is the first treatment candidate to successfully meet all of its clinical endpoints in a global, prospective LN trial,” Parikh said in a news release.
“Voclosporin, when added to standard of care, achieved the highest complete remission rate of any global, active LN trial, and this was accomplished with extremely low-dose steroid exposure,” Parikh added. “The possibility of achieving a better clinical response while avoiding the significant side effects associated with prolonged exposure to high-dose steroids has the potential to be a game-changer in the management of LN.”
Voclosporin inhibits a protein called calcineurin, which activates immune T-cells, thereby blocking inflammation. The drug has a synergistic and dual mechanism of action that can potentially improve near- and long-term outcomes in patients with lupus nephritis when added to standard of care.
The Phase 2b AURA-LV trial (NCT02141672) compared the effectiveness and safety of voclosporin and a placebo, combined with standard of care (mycophenolate mofetil and steroids), in achieving remission in patients with LN.
The study included 265 patients who were randomly assigned to either receive 23.7 mg or 39.5 mg of voclosporin twice daily, or a placebo.
After 48 weeks of treatment, 49% of patients in the low-dose group and 40% of those in the high-dose group achieved complete remission, compared to 24% in the placebo group.
Also, both voclosporin doses were more efficient in achieving partial remission compared to placebo. At 48 weeks, 70% of patients in the low-dose group and 66% of those in the high-dose group achieved remission, whereas only 49% of patients in the placebo group achieved this result.
The treatment was well-tolerated by the patients, with no reports of unexpected side effects.
Together, these findings support the idea that combining voclosporin with standard of care treatment is better at improving patients’ health compared to standard of care alone.
“We are pleased by the recognition of the medical and scientific communities of the AURA study results,” said Neil Solomons, MD, chief medical officer of Aurinia. “Beyond the remission rates we’ve shown with voclosporin, the significant improvement in [disease activity] scores points towards a durable, immunological effect on a broad range of clinically meaningful lupus outcomes.”
“This data provides us with tremendous confidence that we can execute a successful Phase  program and make a meaningful impact on patients’ lives,” Solomons concluded.
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