LUPKYNIS Associated with a Statistically Significant 53% Reduction in Risk of Renal-Related Event or Death
LUPKYNIS Associated with a Statistically Significant 53% Reduction in Risk of Renal-Related Event or Death
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phase 3medical
Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.
lupus nephritismedical
Lupus nephritis is a condition in which a person’s immune system attacks the kidneys, causing inflammation and damage to the organs’ filtering function and leading to blood or protein in the urine and, in severe cases, kidney failure. For investors, it defines a specific, medically serious patient group and treatment need: success or failure of therapies, clinical trials, regulatory approvals, and pricing decisions for drugs aimed at this condition can meaningfully change a biotech or pharma company’s revenue prospects — like fixing a costly, central leak in a building that determines the value of the whole property.
hazard ratiomedical
A hazard ratio is a way scientists compare the chance of something happening over time between two groups, like patients taking different medicines. If the ratio is high, it means one group is more likely to experience the event sooner or more often, which helps determine how effective a treatment is or how risky a situation might be.
p=0.0007medical
p=0.0007 is a statistical measure saying there is a 0.07% chance that the observed result would happen purely by random luck if there were actually no real effect. For investors, such a low p-value signals very strong evidence that a reported finding (for example, a drug effect, trial result, or performance change) is unlikely to be a fluke, similar to flipping a coin dozens of times and getting an extremely unlikely streak; however, it doesn’t by itself prove practical importance or rule out other flaws in the study.
proteinuriamedical
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.
time-to-event analysismedical
A time-to-event analysis measures how long it takes for a specific outcome to occur — for example, drug approval, disease progression, or failure of a medical device — and accounts for people who haven’t yet experienced the outcome by the study’s end. Investors care because it shows not just whether an outcome happens but when it’s likely to happen, like a timetable for expected value events, helping assess risk, timing of returns and comparative performance.
complete renal responsemedical
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.
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— New Analysis of the AURORA 1 Phase 3 Study Presented at EULAR 2026 Congress —
ROCKVILLE, Md. & EDMONTON, Alberta--(BUSINESS WIRE)--
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) today announced that a new analysis of the AURORA 1 Phase 3 study of LUPKYNIS® in the treatment of lupus nephritis is being presented at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress (EULAR 2026 Presentation). This new analysis on the safety population of 356 patients (178 on LUPKYNIS and 178 on placebo) indicates that LUPKYNIS was associated with a statistically significant 53% reduction in the risk of renal-related event or death (hazard ratio=0.47; p=0.0007). Hazard ratios (HRs) favored treatment with LUPKYNIS for the following individual components of the composite endpoint: death (HR=0.19 [an 81% reduction in risk]; p=0.0929), treatment failure (HR=0.45 [a 55% reduction in risk]; p=0.0062) and worsening proteinuria (HR=0.22 [a 78% reduction in risk]; p<0.0001).
“This new time-to-event analysis demonstrates LUPKYNIS’ favorable effect on clinically important outcomes in lupus nephritis patients,” commented Amit Saxena, MD, Associate Professor of Medicine, NYU Grossman School of Medicine Division of Rheumatology and lead author of the EULAR presentation. “LUPKYNIS is the only treatment that has demonstrated a statistically significant improvement in complete renal response (CRR) in as short as 6 months in a randomized Phase 3 clinical study. These new results further characterize the benefits that LUPKYNIS can bring to patients suffering from lupus nephritis.”
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, 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.
