Aurinia Showcases LUPKYNIS® for Lupus Nephritis at EULAR 2024

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) has announced the presentation of new data at the European Alliance of Associations for Rheumatology (EULAR) 2024 in Vienna. The presented data underscores the previously proven safety and efficacy of LUPKYNIS® (voclosporin), a second-generation calcineurin inhibitor (CNI), in treating adult patients with active lupus nephritis (LN).

The data arose from a propensity analysis that compared the combined results of the AURA-LV and AURORA 1 studies with the Aspreva Lupus Management Study (ALMS). This analysis suggested that a triple immunosuppressive regimen of LUPKYNIS, combined with lower-dose mycophenolate mofetil (MMF) and low-dose steroids, led to quicker and more substantial reductions in proteinuria, reduced overall steroid exposure, and demonstrated similar adverse event rates compared to dual therapy regimens using high-dose glucocorticoids with either higher doses of MMF or cyclophosphamide.

Safety and efficacy comparisons for patients with active LN from ALMS and AURA-LV/AURORA 1 were conducted at three and six months. Patients on the LUPKYNIS-based regimen experienced more than a 50% reduction in steroid use at six months and achieved a urine protein creatinine ratio (UPCR) of less than 0.5 mg/mg more quickly than those on high-dose two-drug regimens. Additionally, these patients showed over a 50% reduction in UPCR faster than their counterparts in the ALMS study. These results endorse current guidelines suggesting that LUPKYNIS with lower-dose MMF and low-dose steroids should be considered as initial therapy for active LN patients.

Lupus nephritis (LN) is a severe form of systemic lupus erythematosus (SLE), affecting around 120,000 people in the United States, with women and people of color being disproportionately impacted. LN poses significant health challenges, often leading to irreversible kidney damage if not managed properly. Despite guidelines recommending routine LN screenings for SLE patients, research indicates that around 50% of SLE patients are not screened, and 77% of LN patients do not receive proper treatment. Aurinia Pharmaceuticals is dedicated to improving outcomes for LN patients through education and advocating for routine screening and advanced therapies.

LUPKYNIS (voclosporin) is the first oral medication approved by the U.S. Food and Drug Administration and the European Commission for treating adult patients with active lupus nephritis. This second-generation CNI works by suppressing immune responses and stabilizing kidney cells. The AURORA Clinical Program, including the pivotal AURORA 1 trial and its extension AURORA 2 trial, highlighted the significance of LUPKYNIS plus standard care in maintaining kidney health in active LN patients without relying on high-dose glucocorticoids. This program is unique for its three-year LN treatment and follow-up with MMF and steroids.

Aurinia Pharmaceuticals is a fully integrated biopharmaceutical firm focused on providing treatments for autoimmune diseases with high unmet needs. The company launched LUPKYNIS in January 2021, marking the first FDA-approved oral therapy for adult patients with active lupus nephritis. Aurinia's headquarters are in Edmonton, Alberta, with a U.S. office in Rockville, Maryland, and its efforts are geared towards global development.