Aurinia Announces Initiation of PRESERVE, a Study Investigating the Combination of LUPKYNIS and Belimumab, Obinutuzumab or Anifrolumab in Patients with Lupus Nephritis

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Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) today 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 6 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 6 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. “Unfortunately, even with the newer agents approved in the past few years, the majority of patients do not achieve CRR by 6 months, and many do not achieve CRR even by 12 months.” “There is great mechanistic rationale in combining LUPKYNIS with these biologic agents to improve outcomes,” commented Arvind Madan, MD, Physician and Principal Investigator of the Research Division at Central Florida Kidney Specialists and Co-Lead Investigator of PRESERVE. “LUPKYNIS protects the kidneys by directly stabilizing podocytes and inhibiting T cell activation, belimumab and obinutuzumab inhibit B cell activation, and anifrolumab blocks type 1 interferon signaling. By taking a multitarget therapeutic approach that intervenes in non-redundant biological pathways, each of which independently contribute to nephron loss, there is the potential to stop nephron damage more rapidly in the short term and preserve more kidney function in the long term.” About Aurinia Auri...

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