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
Aurinia is a biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS (voclosporin), the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis. Aurinia is also developing aritinercept, a dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL) for the potential treatment of autoimmune diseases.
Forward-Looking Statements
This press release contains forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable U.S. securities law. We caution investors that forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and involve substantial risks and uncertainties that could cause the actual outcomes to differ materially from what we currently expect. These risks and uncertainties include, but are not limited to, those associated with the conduct, timing and results of clinical studies and other risks and uncertainties identified in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements in this press release apply only as of the date made, and we undertake no obligation to update or revise any forward-looking statements to reflect subsequent events or circumstances. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business, can be found in Aurinia’s most recent Annual Report on Form 10-K and its other public available filings available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedarplus.ca or the U.S. Securities and Exchange Commission’s Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar, and on Aurinia’s website at www.auriniapharma.com.
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