Aurinia Presents New Data Highlighting Real-World Utilization and Value of LUPKYNIS® in Treating Lupus Nephritis at American Society of Nephrology Kidney Week 2024
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) announced the acceptance of six abstracts at the American Society of Nephrology (ASN) Kidney Week 2024. The data reinforces the clinical importance of LUPKYNIS® (voclosporin) for treating adults with active lupus nephritis (LN). Key highlights include:
1. New real-world baseline data from ENLIGHT-LN, a U.S.-based registry of LN patients treated with LUPKYNIS, providing insights into its effectiveness and usage patterns.
2. Two studies exploring LUPKYNIS's effects on podocytes in LN and idiopathic nephrotic syndrome, showing enhanced podocyte cytoskeletal stability at lower concentrations compared to older treatments.
3. LUPKYNIS demonstrated significant improvements in proteinuria, hypercoagulability, lipid profiles, and cell viability in a preclinical model of idiopathic nephrotic syndrome.
These findings highlight LUPKYNIS's role in preserving kidney function and differentiate it from first-generation calcineurin inhibitors.
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) ha annunciato l'accettazione di sei abstract per la Kidney Week 2024 della American Society of Nephrology (ASN). I dati rafforzano l'importanza clinica di LUPKYNIS® (voclosporina) nel trattamento degli adulti con nefriti lupica attiva (LN). I punti salienti includono:
1. Nuovi dati reali di base provenienti da ENLIGHT-LN, un registro statunitense di pazienti con LN trattati con LUPKYNIS, che forniscono approfondimenti sulla sua efficacia e sui modelli di utilizzo.
2. Due studi che esplorano gli effetti di LUPKYNIS sui podociti in LN e nella sindrome nefrotica idiopatica, mostrando una stabilità strutturale del citoscheletro dei podociti migliorata a concentrazioni più basse rispetto ai trattamenti precedenti.
3. LUPKYNIS ha dimostrato significativi miglioramenti nella proteinuria, nell'ipercoagulabilità, nei profili lipidici e nella vitalità cellulare in un modello preclinico di sindrome nefrotica idiopatica.
Questi risultati evidenziano il ruolo di LUPKYNIS nella preservazione della funzione renale e lo differenziano dagli inibitori della calcineurina di prima generazione.
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) anunció la aceptación de seis resúmenes en la Kidney Week 2024 de la American Society of Nephrology (ASN). Los datos refuerzan la importancia clínica de LUPKYNIS® (voclosporina) para tratar a adultos con nefritis lúpica activa (LN). Los aspectos más destacados incluyen:
1. Nuevos datos de referencia del mundo real de ENLIGHT-LN, un registro basado en EE. UU. de pacientes con LN tratados con LUPKYNIS, que proporcionan información sobre su efectividad y patrones de uso.
2. Dos estudios que exploran los efectos de LUPKYNIS en los podocitos en LN y en el síndrome nefrótico idiopático, mostrando una estabilidad del citoesqueleto de podocitos mejorada a concentraciones más bajas en comparación con tratamientos anteriores.
3. LUPKYNIS demostró mejoras significativas en proteinuria, hipercoagulabilidad, perfiles lipídicos y viabilidad celular en un modelo preclínico de síndrome nefrótico idiopático.
Estos hallazgos destacan el papel de LUPKYNIS en la preservación de la función renal y lo diferencian de los inhibidores de calcineurina de primera generación.
아우리니아 제약 (NASDAQ: AUPH)이 2024년 미국 신장학회(ASN) 신장 주간에서 6개의 초록이 수락되었다고 발표했습니다. 이 데이터는 LUPKYNIS® (볼코스포린)가 활성 루푸스 신염 (LN)을 앓고 있는 성인 치료에 있어서 임상적 중요성을 강화합니다. 주요 하이라이트는 다음과 같습니다:
1. LUPKYNIS로 치료받는 LN 환자의 미국 기반 레지스트리인 ENLIGHT-LN의 새로운 실제 기초 데이터로, 효능 및 사용 패턴에 대한 통찰력을 제공합니다.
2. LN과 특발성 신증후군에서 LUPKYNIS가 포도세포에 미치는 영향을 조사한 두 연구로, 이전 치료에 비해 낮은 농도에서 포도세포의 세포골격 안정성이 향상된 것을 보여줍니다.
3. LUPKYNIS는 특발성 신증후군의 전임상 모델에서 단백뇨, 고응집성, 지질 프로필 및 세포 생존율에서 유의미한 개선을 보였습니다.
이러한 결과는 신장 기능을 보존하는 데 있어 LUPKYNIS의 역할을 강조하며, 1세대 칼시뉴린 억제제와 차별화됩니다.
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) a annoncé l'acceptation de six résumés lors de la Kidney Week 2024 de l'American Society of Nephrology (ASN). Les données renforcent l'importance clinique de LUPKYNIS® (voclosporin) dans le traitement des adultes atteints de néphrite lupique active (LN). Les points forts incluent :
1. De nouvelles données de référence du monde réel tirées de l'ENLIGHT-LN, un registre basé aux États-Unis de patients atteints de LN traités par LUPKYNIS, fournissant des informations sur son efficacité et ses modèles d'utilisation.
2. Deux études explorant les effets de LUPKYNIS sur les podocytes dans la LN et le syndrome néphrotique idiopathique, montrant une stabilité cytosquelettique des podocytes améliorée à des concentrations plus faibles par rapport aux traitements plus anciens.
3. LUPKYNIS a démontré des améliorations significatives en matière de protéinurie, d'hypercoagulabilité, de profils lipidiques et de viabilité cellulaire dans un modèle préclinique de syndrome néphrotique idiopathique.
Ces résultats soulignent le rôle de LUPKYNIS dans la préservation de la fonction rénale et le distinguent des inhibiteurs de la calcineurine de première génération.
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) gab die Akzeptanz von sechs Abstracts für die Kidney Week 2024 der American Society of Nephrology (ASN) bekannt. Die Daten bekräftigen die klinische Bedeutung von LUPKYNIS® (Voclosporin) zur Behandlung von Erwachsenen mit aktiver Lupusnephritis (LN). Wichtige Highlights sind:
1. Neue reale Basisdaten aus ENLIGHT-LN, einem in den USA basierten Register von LN-Patienten, die mit LUPKYNIS behandelt wurden, und Insights in die Wirksamkeit und Nutzungsmuster.
2. Zwei Studien, die die Auswirkungen von LUPKYNIS auf Podozyten in LN und idiopathischem nephrotischem Syndrom untersuchen und eine verbesserte Stabilität des Zytoskeletts der Podozyten bei niedrigeren Konzentrationen im Vergleich zu älteren Behandlungen zeigen.
3. LUPKYNIS zeigte signifikante Verbesserungen bei Proteinurie, Hyperkoagulabilität, Lipidprofilen und Zellviabilität in einem präklinischen Modell des idiopathischen nephrotischen Syndroms.
Diese Ergebnisse heben die Rolle von LUPKYNIS bei der Erhaltung der Nierenfunktion hervor und unterscheiden es von Calcineurininhibitoren der ersten Generation.
- Acceptance of six abstracts at ASN Kidney Week 2024, reinforcing LUPKYNIS's clinical importance
- ENLIGHT-LN registry providing real-world data on LUPKYNIS effectiveness and usage patterns
- Studies showing LUPKYNIS's superior effects on podocyte cytoskeletal stability compared to older treatments
- LUPKYNIS demonstrated significant improvements in various kidney health markers in preclinical models
- None.
Insights
The presentation of new data on LUPKYNIS® (voclosporin) at ASN Kidney Week 2024 provides valuable insights into its real-world utilization and effectiveness in treating lupus nephritis (LN). Key highlights include:
- Baseline data from the ENLIGHT-LN registry, involving 123 patients, offers a foundation for understanding LUPKYNIS's real-world effectiveness and usage patterns, particularly in Black and Hispanic/Latino populations disproportionately affected by LN.
- Two studies explore LUPKYNIS's effects on podocytes, suggesting enhanced podocyte cytoskeletal stability at lower concentrations compared to older treatments like cyclosporine A and tacrolimus.
- LUPKYNIS showed significant improvements in proteinuria, hypercoagulability and lipid profiles in a preclinical model of idiopathic nephrotic syndrome.
These findings reinforce LUPKYNIS's potential as an advanced treatment option for LN, particularly its ability to preserve kidney function. The real-world data and mechanistic insights presented could strengthen physician confidence in prescribing LUPKYNIS, potentially driving adoption and sales growth for Aurinia Pharmaceuticals.
While this news doesn't provide direct financial figures, it has positive implications for Aurinia Pharmaceuticals (NASDAQ: AUPH) and its flagship product LUPKYNIS:
- The extensive data presentation (6 abstracts) at a major nephrology conference enhances LUPKYNIS's scientific credibility and visibility among key prescribers.
- Real-world data from the ENLIGHT-LN registry, especially in underrepresented populations, could support broader adoption and potentially expand market reach.
- Mechanistic studies differentiating LUPKYNIS from older treatments may justify its premium pricing and support reimbursement decisions.
- Positive results in idiopathic nephrotic syndrome hint at potential label expansion opportunities, which could significantly increase LUPKYNIS's market potential.
These factors could contribute to accelerated revenue growth for LUPKYNIS, Aurinia's primary revenue driver. However, investors should note that translating scientific data into commercial success takes time and faces competition and reimbursement challenges in the nephrology market.
“The data featured at ASN elucidate the critical role LUPKYNIS plays in advancing the treatment of lupus nephritis, especially in populations disproportionately impacted by the disease. We’re particularly excited about moving our ENLIGHT-LN™ registry forward, as clinicians need insights into real-world treatment patterns. Additionally, we continue adding to our growing body of evidence that the unique mechanism of action of LUPKYNIS affects podocytes, resulting in significant impact on kidney health in adults with active LN,” said Dr. Greg Keenan, Chief Medical Officer of Aurinia.
New real-world baseline data from ENLIGHT-LN, a
This initial analysis of baseline data from 123 patients with biopsy-confirmed LN who are initiating or have initiated treatment with LUPKYNIS within the last 12 months provides a critical foundation for understanding the real-world effectiveness and usage patterns of LUPKYNIS. The subset of patients includes high percentages of Black and Hispanic and/or Latino patients, reflecting the larger population of LN in the US and the communities disproportionately affected by lupus and LN.
Two new studies uncover the potential effects of LUPKYNIS on podocytes in LN and idiopathic nephrotic syndrome compared to older treatments
A new study explored the impact of cyclosporine A (CsA), tacrolimus (TAC), and LUPKYNIS on podocyte cell biology and biomechanics. Using an integrative approach that combined classical cell biological assay with transcriptomics, quantitative proteomics, and other analyses, the study found that all three therapies modulate podocyte cytoskeletal architecture, but LUPKYNIS enhanced podocyte cytoskeletal stability at lower concentrations than CsA and TAC.
Another study investigated the effects of LUPKYNIS in a preclinical model of idiopathic nephrotic syndrome. Results showed that LUPKYNIS significantly improved proteinuria, reduced hypercoagulability, enhanced lipid profiles, and showed significantly better cell viability and cytoskeletal integrity, in comparison to CsA.
Together, these findings highlight the important role that LUPKYNIS plays in preserving kidney function and provide further evidence differentiating LUPKYNIS from first-generation calcineurin inhibitors.
Following is the complete guide to Aurinia’s accepted abstracts at ASN 2024:
Title: Enlight-LN Registry: Baseline Demographics and Clinical Characteristics of an Initial Cohort of Patients Treated with Voclosporin for Lupus Nephritis in
Authors: Niloofar Nobakht, Laura B. Geraldino-Pardilla, Leanna M. Wise, Mohammad Kamgar, Lily Cipolla, Lucy S. Hodge, Keelin Dahl
Date: Thursday, October 24, 2024
Time: 10:00 a.m. – 12:00 p.m. PT
Poster Number: TH-PO653
Title: Disease Targeting Properties of Voclosporin in Renal Transplant and Lupus Nephritis Patients
Authors: Simon Zhou, Linda M. Rehaume, Ernie Yap, Henry Leher, Lucy Hodge, Robert B. Huizinga
Date: Thursday, October 24, 2024
Time: 10:00 a.m. – 12:00 p.m. PT
Poster Number: TH-PO642
Title: Immunologic Changes Over Time in Repeat Kidney Biopsies from the AURORA Studies of Voclosporin in Lupus Nephritis
Authors: Samir V. Parikh, Maddalena Bolognesi, Ivana Grbesa, Brad H. Rovin, Giorgio Cattoretti, Vincenzo L'Imperio, Arnon Arazi, Lucy S. Hodge, Ernie Yap
Date: Friday, October 25, 2024
Time: 10:00 a.m. – 12:00 p.m. PT
Poster Number: FR-PO839
Title: Integrative Systems Analyses Reveal Calcineurin Inhibitor-Mediated Control of Human Podocyte Biophysics and Physiology
Authors: Jacob M. Wright, Anthony Mendoza, Jonathan C. Haydak, Jenny Wong, Linda M. Rehaume, Kirk N. Campbell, Evren U. Azeloglu, Maria Paola Santini
Date: Saturday, October 26, 2024
Time: 10:00 a.m. – 12:00 p.m. PT
Poster Number: SD-PO549
Title: Voclosporin Ameliorates Proteinuria and Directly Protects Podocytes in a Model of Non-Inflammatory Glomerular Disease
Authors: Yu Kamigaki, Julie A. Dougherty, Amanda P. Waller, Katelyn J. Wolfgang, Linda M. Rehaume, Jennifer L. Cross, Laura E. Biederman, Zackary S. Stevenson, Eman Abdelghani, Bryce A. Kerlin, William E. Smoyer
Date: Saturday, October 26, 2024
Time: 10:00 a.m. – 12:00 p.m. PT
Poster Number: SA-PO709
Title: Characterization of Screening Patterns and Identification of Patients with Lupus Nephritis in a Community Rheumatology Setting
Authors: Nehad Soloman, Jawad Bilal, Romy Cabacungan, Scott Milligan, Andrew Sharobeem, John Tesser, Henry Leher
About Lupus Nephritis
Lupus nephritis (LN) is a serious manifestation of systemic lupus erythematosus (SLE), a chronic and complex autoimmune disease. LN affects approximately 120,000 people in the
Medical guidelines recommend that all SLE patients receive routine LN screenings at every visit. Guidelines also note that delaying LN diagnosis has profound prognostic repercussions. Yet, research shows that approximately
About LUPKYNIS
LUPKYNIS is a second generation calcineurin inhibitor (CNI) with a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney. The AURORA Clinical Program, comprised of the AURORA 1 pivotal trial and AURORA 2 extension trial, demonstrated the importance of LUPKYNIS plus standard of care to preserve kidney health in patients with active LN without reliance on chronic high-dose glucocorticoids. It is the only clinical program to include three years of LN treatment and follow-up with mycophenolate mofetil (MMF) and steroids.
About Aurinia
Aurinia Pharmaceuticals is a fully integrated 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 dedicated to the treatment of adult patients with active lupus nephritis. Aurinia is also developing AUR200, a differentiated, potential best-in-class therapy for autoimmune diseases that targets both BAFF (B-cell Activating Factor) and APRIL (A Proliferation-Inducing Ligand).
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION
LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (LN).
Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.
IMPORTANT SAFETY INFORMATION
BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS
Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death.
CONTRAINDICATIONS: LUPKYNIS is contraindicated in patients taking strong CYP3A4 inhibitors because of the increased risk of acute and/or chronic nephrotoxicity, and in patients who have had a serious/severe hypersensitivity reaction to LUPKYNIS or its excipients.
WARNINGS AND PRECAUTIONS
Lymphoma and Other Malignancies: Immunosuppressants, including LUPKYNIS, increase the risk of developing lymphomas and other malignancies, particularly of the skin. The risk appears to be related to increasing doses and duration of immunosuppression rather than to the use of any specific agent.
Serious Infections: Immunosuppressants, including LUPKYNIS, increase the risk of developing bacterial, viral, fungal, and protozoal infections, including opportunistic infections which lead to serious, including fatal outcomes.
Nephrotoxicity: LUPKYNIS, like other calcineurin inhibitors (CNIs), may cause acute and/or chronic nephrotoxicity. The risk is increased when CNIs are concomitantly administered with drugs associated with nephrotoxicity. Monitor eGFR regularly.
Hypertension: Hypertension is a common adverse reaction of LUPKYNIS therapy and may require antihypertensive therapy. Monitor blood pressure regularly.
Neurotoxicity: LUPKYNIS, like other CNIs, may cause a spectrum of neurotoxicities: severe include posterior reversible encephalopathy syndrome (PRES), delirium, seizure, and coma; others include tremor, paresthesia, headache, and changes in mental status and/or motor and sensory functions. Monitor for neurologic symptoms.
Hyperkalemia: Hyperkalemia, which may be serious and require treatment, has been reported with CNIs, including LUPKYNIS. Concomitant use of agents associated with hyperkalemia may increase the risk for hyperkalemia. Monitor serum potassium levels periodically.
QTc Prolongation: LUPKYNIS prolongs the QTc interval in a dose-dependent manner when dosed higher than the recommended lupus nephritis therapeutic dose. The use of LUPKYNIS in combination with other drugs that are known to prolong QTc may result in clinically significant QT prolongation.
Immunizations: Avoid the use of live attenuated vaccines during treatment with LUPKYNIS. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment with LUPKYNIS.
Pure Red Cell Aplasia: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with another CNI immunosuppressant. If PRCA is diagnosed, consider discontinuation of LUPKYNIS.
Drug-Drug Interactions: Avoid co-administration of LUPKYNIS and strong CYP3A4 inhibitors or with strong or moderate CYP3A4 inducers. Co-administration of LUPKYNIS with strong CYP3A4 inhibitors is contraindicated. Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors. Avoid use of LUPKYNIS with strong or moderate CYP3A4 inducers.
ADVERSE REACTIONS
The most common adverse reactions (≥
SPECIFIC POPULATIONS
Pregnancy: Avoid use of LUPKYNIS.
Lactation: Consider the mother’s clinical need for LUPKYNIS and any potential adverse effects to the breastfed infant when prescribing LUPKYNIS to a lactating woman.
Renal Impairment: LUPKYNIS is not recommended in patients with baseline eGFR ≤45 mL/min/1.73 m2 unless benefit exceeds risk. If used in this population, reduce LUPKYNIS dose.
Hepatic Impairment: For mild or moderate hepatic impairment, reduce LUPKYNIS dose. Avoid use with severe hepatic impairment.
Please see Prescribing Information, including Boxed Warning, and Medication Guide for LUPKYNIS.
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Media & Investor Inquiries:
Andrea Christopher
Corporate Communications & Investor Relations
Aurinia Pharmaceuticals Inc.
achristopher@auriniapharma.com
General Investor Inquiries:
ir@auriniapharma.com
Source: Aurinia Pharmaceuticals Inc.
FAQ
What is LUPKYNIS and what is it used for?
What new data is Aurinia presenting about LUPKYNIS at ASN Kidney Week 2024?
How does LUPKYNIS compare to older treatments for lupus nephritis?
What is the ENLIGHT-LN registry for AUPH's LUPKYNIS?
