Nephrosis, Congenital

ROCKVILLE, Md. & EDMONTON, Alberta--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company), announced today the acceptance of six abstracts, including five poster presentations, at the American Society of Nephrology (ASN) Kidney Week 2024 taking place in San Diego, CA October 23-27. These data reinforce the clinical importance of LUPKYNIS ® (voclosporin), a second generation calcineurin inhibitor (CNI), for the treatment of adults with active lupus nephritis (LN). “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 U.S.-based prospective, observational registry of adult patients with LN treated with LUPKYNIS 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 pro 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 the United States 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 U.S. and disproportionately affects women and people of color. People living with LN have high unmet needs and often face significant barriers to optimal care. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney. 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 50% of SLE patients are not screened for LN and 77% of people with LN go untreated. Aurinia is committed to improving health outcomes for people living with LN by educating patients and providers on the critical need for routine screening and transformative therapies that can help improve health outcomes. 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 (≥3%) were glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite. 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 m 2 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. Contacts Media & Investor Inquiries: Andrea Christopher Corporate Communications & Investor Relations Aurinia Pharmaceuticals Inc. achristopher@auriniapharma.com General Investor Inquiries: ir@auriniapharma.com

Positive phase III results for Roche’s Gazyva/Gazyvaro show superiority to standard therapy alone in people with lupus nephritis The REGENCY study met its primary endpoint, demonstrating statistically significant and clinically meaningful treatment benefits in people with active lupus nephritis Gazyva/Gazyvaro is designed to target an underlying cause of lupus nephritis, aiming to prevent or delay progression to end-stage kidney disease1,2 Lupus nephritis is a potentially life-threatening manifestation of an autoimmune disease affecting 1.7 million people worldwide, primarily women; up to one-third of people on current treatments will progress to end-stage kidney disease within 10 years3-6 26 September 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive topline results from the phase III REGENCY study of Gazyva®/Gazyvaro® (obinutuzumab) in people with active lupus nephritis. In the study, a higher proportion of people treated with Gazyva/Gazyvaro plus standard therapy (mycophenolate mofetil and glucocorticoids) achieved a complete renal response (CRR) at 76 weeks compared to those treated with standard therapy alone. Safety was in line with the well-characterised profile of Gazyva/Gazyvaro. No new safety signals were identified. “Gazyva/Gazyvaro achieved a robust complete renal response rate in lupus nephritis, which is associated with long-term preservation of kidney function and delay or prevention of end-stage kidney disease,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Since dialysis or transplants are often required for patients with advanced kidney disease, these findings could represent an important step forward for people living with this devastating disease.” “I am very excited about today’s announcement that the phase III REGENCY study has met its primary endpoint,” said Dr. Brad H. Rovin, Director of Nephrology and Medical Director of the Center for Clinical Research Management at The Ohio State University Wexner Medical Center, and investigator for the REGENCY study. “The results of REGENCY are compelling. Obinutuzumab could offer the lupus community an effective new treatment option for controlling this difficult disease that can be associated with high morbidity for individuals living with lupus.” Two key secondary endpoints showed statistically significant and clinically meaningful benefits with Gazyva/Gazyvaro - the endpoint proportion of patients achieving CRR with a successful reduction of corticosteroid use, and an improvement in proteinuric response (both at 76 weeks). These endpoints are important indicators for achieving better disease control in lupus nephritis. Other secondary endpoints were not statistically significant, but numerically greater responses were observed for Gazyva/Gazyvaro in several endpoints. * Data are being shared with health authorities, including the US Food and Drug Administration (FDA) and the European Medicines Agency, with the goal of making this potential new treatment option for lupus nephritis available as soon as possible. Data are also being submitted for publication in a medical journal and presentation at a future medical congress. Lupus nephritis is a potentially life-threatening manifestation of an autoimmune disease that affects approximately 1.7 million people worldwide, predominantly women and mostly of colour and childbearing age.3-5, 7 In lupus nephritis, disease-causing B cells drive persistent inflammation that damages the kidneys.2 Despite current treatment options, up to a third of people will develop end-stage kidney disease within 10 years, where dialysis or transplant are the only available options and the risk of mortality is high.6 Data suggest that Gazyva/Gazyvaro depletes disease-causing B cells, helping to limit further damage to the kidneys and potentially preventing or delaying progression to end-stage kidney disease.8 Gazyva/Gazyvaro® was granted Breakthrough Therapy Designation by the US FDA in 2019, based on data from the phase II NOBILITY study.9 Breakthrough Therapy Designation is designed to accelerate the development and regulatory review of medicines intended to treat serious or life-threatening conditions where preliminary clinical evidence has indicated they may demonstrate substantial improvement over existing therapies. In addition to REGENCY, Gazyva/Gazyvaro is being investigated in children and adolescents with lupus nephritis, people with membranous nephropathy, childhood-onset idiopathic nephrotic syndrome and systemic lupus erythematosus (SLE), an autoimmune disease that commonly affects the kidneys and can lead to lupus nephritis.10-13 Our pipeline also includes RG6299 (ASO factor B), an antisense oligonucleotide therapy being investigated in people with primary immunoglobulin A nephropathy at high risk of progression, Lunsumio® (mosunetuzumab), a first-in-class CD20xCD3 T-cell engaging bispecific antibody being investigated in SLE, PiaSky® (crovalimab), a novel recycling monoclonal antibody being investigated in atypical haemolytic uraemic syndrome and RG6382, a CD19xCD3 T-cell engaging bispecific antibody being investigated in SLE.14-18 Gazyva®/Gazyvaro® (obinutuzumab) is a Type II engineered humanised monoclonal antibody designed to attach to CD20, a protein found on certain types of B cells.1 In lupus nephritis, disease-causing B cells drive persistent inflammation that damages the kidneys.2 We can target an underlying cause of lupus nephritis to help gain better control of the disease by depleting disease-causing B cells with Gazyva/Gazyvaro, aiming to protect the kidneys from further damage and potentially prevent or delay progression to end-stage kidney disease.1,2,8 Gazyva/Gazyvaro is already approved in 100 countries for various types of lymphoma. In the United States, Gazyva/Gazyvaro is part of a collaboration between Genentech and Biogen. REGENCY [NCT04221477] is a phase III, randomised, double-blind, placebo-controlled, multicentre study investigating the efficacy and safety of Gazyva®/Gazyvaro® (obinutuzumab) plus standard therapy (mycophenolate mofetil and glucocorticoids) in people with active/chronic International Society of Nephrology/Renal Pathology Society 2003 proliferative Class III or IV lupus nephritis, with or without Class V. The study enrolled 271 people, who were randomised 1:1 to receive either biannual intravenous dosing of Gazyva/Gazyvaro plus standard therapy or placebo plus standard therapy. REGENCY was designed based on robust phase II data and conducted during the COVID-19 pandemic. The study population was representative of the real-world population of people with lupus nephritis. The primary endpoint was the proportion of people who achieved complete renal response (CRR) at 76 weeks. Key secondary endpoints included the proportion of people who achieved CRR at week 76 with successful reduction of corticosteroid use (prednisone taper); the proportion who achieved proteinuric response at 76 weeks; mean change in estimated glomerular filtration rate at 76 weeks; death or renal related events through week 76 and overall renal response at 50 weeks. Safety and tolerability were also assessed. Lupus nephritis is a potentially life-threatening manifestation of systemic lupus erythematosus, an autoimmune disease that commonly affects the kidneys.3 Lupus nephritis affects approximately 1.7 million people worldwide.4,5 Lupus nephritis has a profound impact on the lives and outlook of those affected and even with the latest treatments, the damage caused to the kidneys usually gets worse over time, with up to a third of people progressing to end-stage kidney disease within 10 years, where the only options are dialysis or transplant.6 Lupus nephritis predominantly affects women, mostly women of colour and usually of childbearing age.7 Currently, there is no cure.3 For 20 years, we have combined innovation, scientific expertise and commitment to patients to address unmet needs in kidney diseases. Our industry-leading pipeline includes several ongoing phase I-III clinical studies of immune-mediated investigational therapies with the aim of bringing innovative new treatment options to people living with kidney and kidney-related diseases, including lupus nephritis, membranous nephropathy, immunoglobulin A nephropathy, atypical haemolytic uraemic syndrome, childhood-onset idiopathic nephrotic syndrome and systemic lupus erythematosus, an autoimmune disease that can lead to lupus nephritis. Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. References [1] Herter S, et al. Preclinical activity of the type II CD20 antibody GA101 (obinutuzumab) compared with rituximab and ofatumumab in vitro and in xenograft models. Mol Cancer Ther. 2013;12(10):2031-42 [2] Atisha-Fregoso Y, et al. Meant to B: B cells as a therapeutic target in systemic lupus erythematosus. J Clin Invest. 2021;131(12):e149095 [3] Hocaoglu et al. Incidence, Prevalence, and Mortality of Lupus Nephritis: A Population-Based Study Over Four Decades—The Lupus Midwest Network (LUMEN). Arthritis Rheumatol. 202;75(4):567–73 [4] Tian J, et al. Global epidemiology of systemic lupus erythematosus: a comprehensive systematic analysis and modelling study. Ann Rheum Dis. 2023;82:351-56 [5] Hoi A, et al. Systemic lupus erythematosus. The Lancet. 2024;403(10441):2326-38 [6] Mok C, et al. Treatment of lupus nephritis: consensus evidence and perspectives. Nat Rev Rheumatol. 2023;19:227-38 [7] Anders HJ, Saxena R, Zhao MH, Parodis I, Salmon JE, Mohan C. Lupus nephritis. Nat Rev Dis Primers. 2020;6(1):7. doi: 10.1038/s41572-019-0141-9 [8] Furie RA, et al. B-cell depletion with obinutuzumab for the treatment of proliferative lupus nephritis: a randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2022;81(1):100-7 [9] Roche. FDA grants Breakthrough Therapy Designation for Roche’s Gazyva (obinutuzumab) in Lupus Nephritis. 2019 [Internet, cited September 2024]. Available from: https://www.roche.com/investors/updates/inv-update-2019-09-18 [10] Clinicaltrials.gov. A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants (POSTERITY) [Internet; cited September 2024]. Available from: https://clinicaltrials.gov/study/NCT05039619 [11] Clinicaltrials.gov. Obinutuzumab in Primary MN (ORION) [Internet; cited September 2024]. Available from: https://clinicaltrials.gov/study/NCT05050214 [12] Clinical trials.gov. A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome (INShore) [Internet; cited September 2024]. Available from: https://clinicaltrials.gov/study/NCT05627557 [13] Clinicaltrials.gov. A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus (ALLEGORY) [Internet; cited September 2024]. Available from: https://clinicaltrials.gov/study/NCT04963296 [14] Clinicaltrials.gov. A Study to Evaluate the Efficacy and Safety of RO7434656 in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression (IMAGINATION) [Internet; cited September 2024]. Available from: https://clinicaltrials.gov/study/NCT05797610 [15] Clinicaltrials.gov. A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered Mosunetuzumab to Participants With Systemic Lupus Erythematosus [Internet; cited September 2024]. Available from: https://clinicaltrials.gov/study/NCT05155345 [16] Clinicaltrials.gov. A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS) (COMMUTE-a) [Internet; cited September 2024]. Available from: https://clinicaltrials.gov/study/NCT04861259 [17] Clinicaltrials.gov. A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS) (COMMUTE-p) [internet; cited September 2024]. Available from: https://clinicaltrials.gov/study/NCT04958265 [18] Clinicaltrials.gov. Clinical Study of A-319 in the Treatment of Active/​Refractory Systemic Lupus Erythematosus [internet; cited September 2024]. Available from: https://clinicaltrials.gov/study/NCT06400537 The content above comes from the network. if any infringement, please contact us to modify.

iStock, JHVEPhoto In the Phase III REGENCY study, Gazyva elicited superior complete renal response rates in patients with lupus nephritis versus placebo, positioning Roche’s therapeutic antibody for expansion into the indication. Roche subsidiary Genentech announced on Thursday that Gazyva (obinutuzumab) met its primary efficacy endpoint in the Phase III REGENCY study of lupus nephritis. The pharma will present these data to the FDA and other global health authorities with the goal of securing approvals in this indication. Without revealing specific data, Roche in its announcement indicated that Gazyva treatment elicited “statistically significant and clinically meaningful treatment benefits” in patients with active lupus nephritis. At 76 weeks, more patients treated with Gazyva—given on top of standard therapy with mycophenolate mofetil and glucocorticoids—reached complete renal response (CRR) versus standard therapy alone. Roche CMO Levi Garraway in a statement called this CRR result “robust,” noting that it is “associated with long-term preservation of kidney function and delay or prevention of end-stage kidney disease.” Gazyva also aced two of its key secondary endpoints in REGENCY, including the proportion of patients hitting CRR alongside a successful reduction in corticosteroid use, as well as an improvement in proteinuric response. Both measures are important markers of disease control in lupus nephritis, according to the company. Roche said it will share REGENCY’s findings for presentation at an upcoming medical meeting and for publication in a peer-reviewed journal. Lupus nephritis is a kidney complication caused by the autoimmune disease systemic lupus erythematosus (SLE). In patients with lupus nephritis, B cells cause overactive and persistent inflammation, which damages the kidney and can cause end-stage kidney disease, typically within 10 years. At its most advanced stages, the kidney damage that lupus nephritis causes can only be treated through transplantation or dialysis. Gazyva is an intravenously administered monoclonal antibody that works by targeting the CD20 surface protein, which is commonly found on immature and mature lymphocytes. Once bound to its target, Gazyva can trigger cell death, ultimately leading to an overall decline in the levels of disease-causing B cells. This mechanism of action has won Gazyva several FDA approvals, including for chronic lymphocytic leukemia and follicular lymphoma. Roche is continuing to advance Gazyva into other B cell-mediated diseases, including membranous nephropathy, childhood-onset idiopathic nephrotic syndrome and SLE. Gazyva’s late-stage victory on Thursday continues the industry’s recent winning streak in the autoimmune space. Earlier this week, partners Biogen and UCB reported that their investigational therapy dapirolizumab pegol cleared the Phase III PHOENYCS GO study in SLE , demonstrating significant improvements in moderate-to-severe disease activity versus placebo. Last month, startup Navigator Medicines raked in $100 million in its Series A funding round , which it will use to develop its bispecific antibody NAV-240 for autoimmune conditions.