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

Key Terms

phase 4 medical

Phase 4 is the stage after a drug or vaccine has been approved and is sold to the public, where regulators and companies keep watching how it performs in the real world to detect rare side effects, long‑term effects, or differences in effectiveness across different groups. Think of it as ongoing quality control for a product already on shelves; results can prompt label changes, safety warnings, sales impacts or recalls, all of which matter to investors evaluating risk and future revenue.

complete renal response medical

Complete renal response is a clinical outcome that indicates a patient’s kidneys have returned to near-normal function, usually shown by a big drop in protein leaking into the urine and stable waste levels in the blood. For investors, it matters because this endpoint is a clear signal that a drug or treatment is working in kidney disease trials, which can drive regulatory approval, market adoption, and commercial value much like a successful safety test validates a new car model.

proteinuria medical

Proteinuria is when abnormal amounts of protein are found in a person's urine. It can be a sign that the kidneys aren't working properly, since healthy kidneys usually prevent most proteins from passing into urine. Detecting proteinuria helps doctors identify and monitor kidney problems early.

podocytes medical

Podocytes are specialized cells that wrap around tiny blood vessels in the kidney’s filtering unit and act like a fine mesh or sieve to keep proteins and other important molecules in the blood while letting waste pass into urine. They matter to investors because podocyte damage is a key driver of chronic kidney disease and proteinuria, which influences demand for drugs, medical devices, regulatory approvals, trial outcomes and long‑term healthcare costs.

b cell-activating factor medical

A protein signal made by immune cells that helps B lymphocytes survive, grow and make antibodies; scientists often call it BAFF or BLyS. It matters to investors because drugs that block or modify this signal are major targets for treating autoimmune diseases and some blood cancers, and changes in BAFF levels can be used as biomarkers or trial endpoints that affect drug development, regulatory reviews and market potential.

cd20-directed cytolytic antibody medical

A CD20-directed cytolytic antibody is a lab-made protein that binds to CD20, a marker found on certain white blood cells, and triggers destruction of those cells either by recruiting the immune system or by carrying a cell-killing payload. Think of it as a homing missile that seeks cells with CD20 and causes them to die. It matters to investors because such drugs are a common cancer and autoimmune therapy approach, and their safety, efficacy, and regulatory progress directly affect clinical value and commercial prospects.

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— Multitarget Approach Has Potential to Further Improve Outcomes in This Disease Characterized by Continued Unmet Need —

ROCKVILLE, Md. & EDMONTON, Alberta--(BUSINESS WIRE)-- 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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Investor Inquiries:
ir@auriniapharma.com

Source: Aurinia Pharmaceuticals Inc.