Aurinia Pharmaceuticals announced that it will present positive data from its Phase 2b clinical trial evaluating the efficacy and safety of voclosporin for the treatment of lupus nephritis, showing that the study had met and confirmed its primary endpoint of complete remission in a statistically significant number of treated patients.
Voclosporin is an investigational immunosuppressant with a synergistic and dual mechanism of action, intended to improve near- and long-term outcomes in patients with active lupus nephritis (LN; inflammation of the kidney) when added to standard of care.
“The selection of voclosporin data for two late-breaking oral presentations at key medical meetings underscores the importance of providing the medical community with new information about therapy advancements in the treatment of lupus nephritis,” Neil Solomons, MD, Aurinia’s chief medical officer, said in a press release. “Data presented highlights Aurinia’s commitment to providing lupus nephritis patients with a tolerable and effective treatment option, improving long-term patient outcomes and quality of life.”
The AURA-LV (NCT02141672) study assessing voclosporin was a randomized, controlled double-blind study comparing the efficacy and safety of voclosporin (23.7 mg or 39.5 mg twice daily) in addition to standard of care (mycophenolate mofetil [MMF]), versus standard of care plus placebo, in achieving remission in 265 patients with active LN. Patients were also being tapered to low-dose steroids.
Its primary endpoint was the number of patients who achieved complete remission at 24 weeks, with a confirmation at 26 weeks (measured through 24-hour urine data).
In August, Aurinia announced that AURA-LV had met its primary endpoint at 24 weeks. Complete remission was achieved in 32.6 percent of patients in the low-dose voclosporin group, and in 27.3 percent of those in the high-dose group, compared to 19.3 percent in the control arm.
The trial’s secondary endpoint, partial response, was also met in both low- and high-dose voclosporin groups: 69.7 percent for lose-dose and 65.9 percent for high-dose patients, Aurinia also announced at the time. In contrast, 49.4 percent of control-arm patients achieved a partial response.
Details for the two oral presentations are:
- Mary Anne Dooley, MD, MPH, adjunct professor of Medicine, University of North Carolina Kidney Center, will present, “Speed of Remission with the Use of Voclosporin, MMF & Low Dose Steroids: Results of a Global Lupus Nephritis Study” on Nov. 15 at the ACR/ARHP meeting.
- William Pendergraft, MD, PhD, assistant professor of Medicine in the Division of Nephrology & Hypertension at the University of North Carolina, will present, “AURA-LV: Successful Treatment of Active Lupus Nephritis with Voclosporin” on Nov. 19 at ASN Kidney Week.
The ACR presentation will report data showing that the study met its primary endpoint of a statistically significant improvement in time to complete remission and partial remission in both treatment arms (low-dose and high-dose voclosporin).
In terms of safety, researchers found that the majority of the patients (over 90%) had at least one adverse event. Infection was the most common adverse event (56.2% low-dose group, 63.6% high-dose group, and 50.0% control), followed by gastrointestinal (GI) disorders (41.6% low-dose group, 52.3% high-dose group, and 36.4% control). Serious adverse events were more frequently observed in patients treated with voclosporin (25.8% low-dose, 25.0% high-dose, 15.8% control), but were consistent with those observed in LN patients.
Aurinia researchers believe these promising data will help advance subsequent studies into voclosporin as a therapy for lupus nephritis.