Voclosporin Shows Potential as Lupus Nephritis Therapy in Phase 2b Study

Voclosporin Shows Potential as Lupus Nephritis Therapy in Phase 2b Study
clinical trial data

Aurinia Pharmaceuticals’ voclosporin showed considerable success in a clinical trial of lupus nephritis, according to recent data released by the company. Results found that the drug met the study’s primary goal of complete remission, and met all secondary goals of the ongoing, Phase 2b AURA-LV trial (NCT02141672).

The data were presented at the American Society of Nephrology Kidney Week 2016, held in Chicago on Nov. 15–20.

Principal investigator William Pendergraft, MD, PhD, of the University of North Carolina Kidney Center, shared the data in the presentation AURA-LV: Successful Treatment of Active Lupus Nephritis with Voclosporin,” as part of the “High Impact Clinical Trials” session.

“There is a critical unmet need for an effective therapeutic treatment of lupus nephritis, a devastating and life-altering disease that, if left untreated, can lead to end-stage renal disease and even death,” said Pendergraft in a news release. “Until now, the lupus nephritis clinical trial landscape has been bleak.”

An international study, AURA-LV enrolled 265 patients who were randomized to receive either 23.7 mg or 39.5 mg of voclosporin twice daily, or placebo. The experimental treatment was taken as an add-on to the standard care with CellCept (mycophenolate mofetil) and steroids.

After 24 weeks of treatment, 32.6% of patients in the low-dose group and 27.3% of those in the high-dose group achieved complete remission, compared to 19.3% in the placebo group. This was a statistically significant difference, with the odds ratio of remission two times higher in the low-dose group compared to placebo.

Both voclosporin doses were also better than placebo in achieving partial remission, and in the time it took for patients to reach partial or complete remission. Other secondary measures included a reduction in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score, and improvements in urinary parameters over the 24-week treatment period.

The glomerular filtration rate — a measure of how well the kidneys are working — remained stable in the treatment groups during the trial, and did not differ from placebo-treated patients.

Aurinia reported that adverse events were more common in the two voclosporin groups: 25.8% and 25.0% in the low- and high-dose groups, respectively, compared to 15.8% in the placebo group. Since voclosporin is an immunosuppressant drug, this is an expected result.

The safety profile of the compound is, nevertheless, far better than older drugs blocking calcineurin — the molecular target of voclosporin. Calcineurin controls the production of the immune factor IL-2, which, in turn, orchestrates a T-cell-based immune response.

“The nephrology community’s positive reception to the AURA data is encouraging as we prepare to initiate our single Phase 3 clinical trial of voclosporin in Q2 2017,” said Neil Solomons, MD, Aurinia’s Chief Medical Officer. “We remain committed to progressing this important therapy to market and believe it has the potential to change the paradigm of care for patients living with lupus nephritis, significantly improving long-term outcomes and quality of life.”

The AURA-LV study will continue to run to complete 48 weeks of treatment, at which secondary study endpoints will be measured.

Aurinia is also in the process of starting up a Phase 3 trial of voclosporin — expected to open in mid-2017 — a move the company hopes will provide enough data to request the treatment’s approval.

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