Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) began Monday trading flat, after it announced the initiation of PRESERVE, a Phase 4, multicenter study investigating the combination of LUPKYNIS® and belimumab, obinutuzumab or anifrolumab in patients with lupus nephritis (ClinicalTrials.gov). Planned enrollment is approximately 150 patients across approximately 50 sites in the US. The Study’s primary endpoint is the proportion of patients achieving complete renal response (CRR) at six months.
LUPKYNIS is the only FDA-approved oral therapy for lupus nephritis and the only treatment for lupus nephritis that has shown a statistically significant increase in CRR after six months of therapy.
Belimumab is a B cell-activating factor (BAFF) inhibitor indicated for the treatment of both systemic lupus erythematosus (SLE) and lupus nephritis.
Obinutuzumab is a CD20-directed cytolytic antibody indicated for the treatment of lupus nephritis.
Anifrolumab is a type 1 interferon receptor antagonist indicated for the treatment of SLE.
“As underscored by the recently published American College of Rheumatology guidelines for the treatment of lupus nephritis, the goal of treatment should be to arrest proteinuria, which is the hallmark sign of ongoing kidney damage, as quickly as possible,” commented Anca Askanase, MD, MPH, Chair of the Department of Medicine and Chief of the Division of Rheumatology at Hospital for Special Surgery and Co-Lead Investigator of PRESERVE.
AUPH shares hadn’t yet budged from Thursday’s close of $15.61.
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