Aurinia Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company, which engages in the research, development, and commercialization of therapeutic drugs. The company was founded by Robert Foster, Richard Glickman, and Michael Martin on June 16, 1993 and is headquartered in Victoria, Canada.
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- Aurinia Pharmaceuticals has initiated PRESERVE, a Phase 4 multicenter study combining LUPKYNIS (voclosporin) with belimumab, obinutuzumab, or anifrolumab in lupus nephritis patients. - The trial plans to enroll approximately 150 patients across roughly 50 U.S. sites, with the primary endpoint being the proportion of patients achieving complete renal response at 6 months. - Investigators highlight a multitarget therapeutic approach targeting non-redundant biological pathways—T cells, B cells, and type 1 interferon signaling—to potentially halt nephron damage more rapidly. - LUPKYNIS remains the only FDA-approved oral therapy for lupus nephritis and the only treatment to demonstrate a statistically significant increase in complete renal response at 6 months.
- Dr. George Tidmarsh, head of the FDA's drug center, abruptly resigned Sunday after federal officials began reviewing "serious concerns about his personal conduct." - Aurinia Pharmaceuticals filed a lawsuit alleging Tidmarsh used his FDA position to pursue a "longstanding personal vendetta" against the company's board chair Kevin Tang. - The company claims Tidmarsh's LinkedIn post criticizing their kidney drug caused a 20% stock drop, wiping out over $350 million in shareholder value. - Tidmarsh's departure adds to ongoing leadership turmoil at the FDA, which has lost over 1,000 drug center staffers in the past year.
- FDA's Center for Drug Evaluation and Research Director George Tidmarsh publicly criticized Aurinia Pharmaceuticals' lupus nephritis drug Lupkynis (voclosporin) for having "significant toxicity" without demonstrated direct clinical benefit to patients. - Tidmarsh stated that CDER will reevaluate the use of surrogate endpoints for drug approvals, citing concerns about companies not running trials to demonstrate benefits on hard clinical endpoints like progression to end-stage renal disease. - The FDA official later deleted his LinkedIn posts and clarified that his statements were personal views that do not reflect official FDA or Department of Health and Human Services positions. - Aurinia shares dropped 16.4% following the criticism, highlighting market sensitivity to regulatory concerns about approved therapies based on surrogate endpoints.
- Aurinia Pharmaceuticals reported positive Phase 1 results for aritinercept (AUR200), a dual BAFF/APRIL inhibitor, showing robust and long-lasting reductions in immunoglobulins with excellent safety profile. - Single doses of aritinercept achieved mean reductions of up to 48% in IgA, 55% in IgM, and 20% in IgG at Day 28, supporting once-monthly dosing potential. - The drug was well tolerated across all tested doses (5-300 mg) with no treatment-related serious adverse events or Grade ≥3 adverse events in 61 healthy subjects. - Aurinia plans to initiate clinical studies in at least two autoimmune diseases in the second half of 2025 based on these encouraging pharmacodynamic results.
- High placebo response rates of approximately 40% in systemic lupus erythematosus trials are obscuring the true efficacy of investigational biologics, as patients continue receiving powerful background medications like glucocorticoids and hydroxychloroquine. - Researchers have identified four core strategies to address the "placebo problem," including stabilizing background therapy, applying central expert review, controlling rescue therapy, and acknowledging evolving standard-of-care treatments. - New trial design innovations include enriching study populations with high-disease-activity patients, employing more stringent sustained endpoints, and implementing adaptive features to better detect drug efficacy signals. - Clinical practice approaches now focus on realistic patient expectations for biologics like belimumab and anifrolumab, emphasizing gradual benefit timelines of 3-4 months and steroid-sparing goals rather than miracle cures.
- New analysis of Phase 3 AURORA 1 study reveals that LUPKYNIS-based triple immunosuppressive therapy achieved significantly higher rates of low proteinuria targets compared to standard therapy in lupus nephritis patients. - Patients receiving LUPKYNIS, mycophenolate mofetil, and low-dose glucocorticoids showed 60.9% achievement of UPCR ≤0.4 g/g versus 37.1% in the control group, with comparable adverse event profiles. - Additional findings suggest patients achieving ultra-low proteinuria levels may experience beneficial alterations in lipidomic profiles, potentially reducing cardiovascular disease risk in lupus nephritis patients.
- The global lupus nephritis market is projected to grow significantly by 2034, with the United States accounting for over 80% of the current $1.12 billion market share across major regions. - Several innovative therapies are advancing through clinical trials, including CAR-T cell treatments from companies like Allogene Therapeutics, Adicet Bio, and Caribou Biosciences, which received FDA Fast Track designations. - Key pharmaceutical players including Aurinia Pharmaceuticals, AstraZeneca, and Roche are developing treatments such as voclosporin, anifrolumab, and obinutuzumab to address the significant unmet needs in lupus nephritis management.
- Aurinia Pharmaceuticals is reducing its workforce by 45% to save over $40 million annually, streamlining operations to focus on key assets. - The restructuring prioritizes the growth of Lupkynis (voclosporin) for lupus nephritis and the clinical validation of AUR200 for autoimmune diseases. - Q3 2024 results showed a 24% year-over-year revenue increase to $67.8 million, driven mainly by Lupkynis sales, which reached $55.5 million. - Despite facing investor pressure and leadership changes, Aurinia reaffirms its full-year 2024 net product revenue guidance between $210 million and $220 million.
- The Japanese Ministry of Health, Labour, and Welfare approved Lupkynis (voclosporin) in combination with mycophenolate mofetil for treating lupus nephritis. - This approval was based on the AURORA Clinical Program, which demonstrated Lupkynis' efficacy and safety in treating lupus nephritis patients. - Aurinia Pharmaceuticals is eligible to receive a $10 million payment from Otsuka Pharmaceutical, along with royalties on net sales, following the approval. - Lupkynis, a second-generation calcineurin inhibitor, is now approved in Japan, the U.S., the U.K., the European Union, and Switzerland for lupus nephritis.
- Aurinia Pharmaceuticals has dosed the first subject in a Phase Ia trial of AUR200, an IgG4 Fc-fusion protein, for autoimmune diseases. - The trial aims to assess the safety, tolerability, pharmacokinetics, and biomarker changes of AUR200 in healthy volunteers, with results expected in the first half of next year. - AUR200 targets both B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL), crucial cytokines in B-cell regulation. - Preclinical studies showed AUR200 reduced disease activity markers and improved survival in a lupus mouse model, suggesting potential as a best-in-class treatment.
