Biopharmaceutical company Aurinia Pharmaceuticals (NASDAQ: AUPH) declared on Monday that it has initiated the PRESERVE Phase 4, multicentre study evaluating LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab in patients with lupus nephritis.
The study will enrol approximately 150 patients across around 50 sites in the US and will assess the proportion of patients achieving complete renal response at six months as its primary endpoint. The programme is designed to evaluate a multi-target treatment approach in a disease characterised by significant unmet medical need.
LUPKYNIS is the only FDA-approved oral therapy for lupus nephritis and has demonstrated a statistically significant improvement in complete renal response at six months. The combination agents include belimumab, a BAFF inhibitor; obinutuzumab, a CD20-directed cytolytic antibody; and anifrolumab, a type 1 interferon receptor antagonist.
Aurinia said the study aims to further evaluate combination regimens in lupus nephritis, where outcomes remain limited despite existing therapies.
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