Latest news with #anti-APRIL
Korea Herald
5 days ago
- Health
- Korea Herald
ERA Congress: Long-term data show sustained efficacy and safety of zigakibart in patients with IgA nephropathy
VIENNA, June 5, 2025 /PRNewswire/ -- New 100-week data from the ongoing Phase 1/2 study of zigakibart, an investigational anti-APRIL monoclonal antibody, reinforce its potential as a disease-modifying treatment for IgA nephropathy (IgAN). Findings presented today at the 62 nd ERA Congress demonstrate sustained proteinuria remission, stable kidney function, and a reassuring safety profile. IgAN is the most common form of glomerular disease worldwide and a frequent cause of chronic kidney disease. Its pathogenesis is marked by inflammation and progressive kidney damage, which can lead to kidney failure. Many patients are unaware they have the condition until significant kidney damage has occurred, and 50% of IgAN patients will ultimately develop kidney failure. By targeting the APRIL pathway and reducing production of pathogenic galactose-debecause ofgA1), zigakibart addresses a key driver of disease progression. "Zigakibart is designed to intercept the initiating factor in IgAN pathogenesis, offering a new approach that may halt or significantly delay progression", explained lead investigator Professor Jonathan Barratt. The ADU-CL-19 trial included 40 adults with biopsy-confirmed IgAN and persistent proteinuria despite stable supportive therapy. Patients received zigakibart every two weeks via intravenous infusion or subcutaneous injection, in addition to maximally tolerated renin–angiotensin system inhibitors (RASi) unless RASi-intolerant – demonstrating efficacy beyond standard care. At Week 100, proteinuria was reduced by 60% from baseline. Over half of patients (55%) reached <500 mg/24 h, and 31% achieved <300 mg/24 h, indicating deeper remission. Estimated glomerular filtration rate (eGFR) remained stable across subgroups. "The consistency of eGFR stabilisation over 100 weeks, even across proteinuria response groups, is particularly encouraging," said Prof. Barratt. Treatment also led to sustained reductions in serum immunoglobulins, including a 74% drop in IgA and pathogenic Gd-IgA1, consistent with APRIL pathway inhibition. Zigakibart was well tolerated throughout. Most adverse events were mild or moderate, with no treatment-related serious infections or discontinuations. Infections were the most common AEs; the study coincided with a high prevalence of COVID-19. This is the longest duration of eGFR stabilisation reported for an anti-APRIL agent in IgAN. "These long-term results build confidence in zigakibart as a potential cornerstone therapy for IgAN," said Prof. Barratt. "We're excited to see how the upcoming Phase 3 trials will further define its role." The global Phase 3 BEYOND study is now evaluating zigakibart in a broader population, with primary proteinuria endpoints at 40 weeks and long-term kidney function through 104 weeks.
Yahoo
6 days ago
- Health
- Yahoo
ERA Congress: Long-term data show sustained efficacy and safety of zigakibart in patients with IgA nephropathy
VIENNA, June 4, 2025 /PRNewswire/ -- New 100-week data from the ongoing Phase 1/2 study of zigakibart, an investigational anti-APRIL monoclonal antibody, reinforce its potential as a disease-modifying treatment for IgA nephropathy (IgAN). Findings presented today at the 62nd ERA Congress demonstrate sustained proteinuria remission, stable kidney function, and a reassuring safety profile. IgAN is the most common form of glomerular disease worldwide and a frequent cause of chronic kidney disease. Its pathogenesis is marked by inflammation and progressive kidney damage, which can lead to kidney failure. Many patients are unaware they have the condition until significant kidney damage has occurred, and 50% of IgAN patients will ultimately develop kidney failure. By targeting the APRIL pathway and reducing production of pathogenic galactose-debecause ofgA1), zigakibart addresses a key driver of disease progression. "Zigakibart is designed to intercept the initiating factor in IgAN pathogenesis, offering a new approach that may halt or significantly delay progression", explained lead investigator Professor Jonathan Barratt. The ADU-CL-19 trial included 40 adults with biopsy-confirmed IgAN and persistent proteinuria despite stable supportive therapy. Patients received zigakibart every two weeks via intravenous infusion or subcutaneous injection, in addition to maximally tolerated renin–angiotensin system inhibitors (RASi) unless RASi-intolerant – demonstrating efficacy beyond standard care. At Week 100, proteinuria was reduced by 60% from baseline. Over half of patients (55%) reached <500 mg/24 h, and 31% achieved <300 mg/24 h, indicating deeper remission. Estimated glomerular filtration rate (eGFR) remained stable across subgroups. "The consistency of eGFR stabilisation over 100 weeks, even across proteinuria response groups, is particularly encouraging," said Prof. Barratt. Treatment also led to sustained reductions in serum immunoglobulins, including a 74% drop in IgA and pathogenic Gd-IgA1, consistent with APRIL pathway inhibition. Zigakibart was well tolerated throughout. Most adverse events were mild or moderate, with no treatment-related serious infections or discontinuations. Infections were the most common AEs; the study coincided with a high prevalence of COVID-19. This is the longest duration of eGFR stabilisation reported for an anti-APRIL agent in IgAN. "These long-term results build confidence in zigakibart as a potential cornerstone therapy for IgAN," said Prof. Barratt. "We're excited to see how the upcoming Phase 3 trials will further define its role." The global Phase 3 BEYOND study is now evaluating zigakibart in a broader population, with primary proteinuria endpoints at 40 weeks and long-term kidney function through 104 weeks. View original content: SOURCE ERA Congress Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Cision Canada
6 days ago
- Health
- Cision Canada
ERA Congress: Long-term data show sustained efficacy and safety of zigakibart in patients with IgA nephropathy
VIENNA, June 4, 2025 /CNW/ -- New 100-week data from the ongoing Phase 1/2 study of zigakibart, an investigational anti-APRIL monoclonal antibody, reinforce its potential as a disease-modifying treatment for IgA nephropathy (IgAN). Findings presented today at the 62 nd ERA Congress demonstrate sustained proteinuria remission, stable kidney function, and a reassuring safety profile. IgAN is the most common form of glomerular disease worldwide and a frequent cause of chronic kidney disease. Its pathogenesis is marked by inflammation and progressive kidney damage, which can lead to kidney failure. Many patients are unaware they have the condition until significant kidney damage has occurred, and 50% of IgAN patients will ultimately develop kidney failure. By targeting the APRIL pathway and reducing production of pathogenic galactose-debecause ofgA1), zigakibart addresses a key driver of disease progression. "Zigakibart is designed to intercept the initiating factor in IgAN pathogenesis, offering a new approach that may halt or significantly delay progression", explained lead investigator Professor Jonathan Barratt. The ADU-CL-19 trial included 40 adults with biopsy-confirmed IgAN and persistent proteinuria despite stable supportive therapy. Patients received zigakibart every two weeks via intravenous infusion or subcutaneous injection, in addition to maximally tolerated renin–angiotensin system inhibitors (RASi) unless RASi-intolerant – demonstrating efficacy beyond standard care. At Week 100, proteinuria was reduced by 60% from baseline. Over half of patients (55%) reached <500 mg/24 h, and 31% achieved <300 mg/24 h, indicating deeper remission. Estimated glomerular filtration rate (eGFR) remained stable across subgroups. "The consistency of eGFR stabilisation over 100 weeks, even across proteinuria response groups, is particularly encouraging," said Prof. Barratt. Treatment also led to sustained reductions in serum immunoglobulins, including a 74% drop in IgA and pathogenic Gd-IgA1, consistent with APRIL pathway inhibition. Zigakibart was well tolerated throughout. Most adverse events were mild or moderate, with no treatment-related serious infections or discontinuations. Infections were the most common AEs; the study coincided with a high prevalence of COVID-19. This is the longest duration of eGFR stabilisation reported for an anti-APRIL agent in IgAN. "These long-term results build confidence in zigakibart as a potential cornerstone therapy for IgAN," said Prof. Barratt. "We're excited to see how the upcoming Phase 3 trials will further define its role." The global Phase 3 BEYOND study is now evaluating zigakibart in a broader population, with primary proteinuria endpoints at 40 weeks and long-term kidney function through 104 weeks.
Yahoo
21-03-2025
- Business
- Yahoo
FDA Approves Expanded Use Of Novartis Rare Disease Drug As Only Treatment For Rare Type Of Kidney Disease
On Thursday, the U.S. Food and Drug Administration (FDA) approved Novartis AG's (NYSE:NVS) oral Fabhalta (iptacopan) for adults with C3 glomerulopathy (C3G) to reduce proteinuria (protein in the urine), making it the first and only treatment approved for this condition. C3G is a rare kidney disease characterized by damage to the glomeruli (kidney filters) due to dysregulation of the complement system, specifically the alternative pathway, leading to C3 protein accumulation. Also Read: The pivotal Phase 3 APPEAR-C3G study evaluated the efficacy and safety of twice-daily oral Fabhalta in adult patients with C3G. Treatment with Fabhalta resulted in a clinically meaningful reduction in proteinuria, which was seen as early as 14 days and sustained at 12 months. Similarly, in the open-label period, proteinuria reduction was seen in participants who switched to Fabhalta. Last month, Fabhalta received a positive CHMP Opinion in C3G by the European Medicines Agency (EMA). Regulatory reviews for this indication are ongoing in China and Japan. This is the third US approval for Fabhalta and its second within the Novartis kidney disease portfolio since August 2024, when Fabhalta was granted accelerated approval by the FDA for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. Continued approval for this indication is contingent upon confirmatory evidence. Fabhalta received its first FDA approval in December 2023 for adults with paroxysmal nocturnal hemoglobinuria (PNH). In the fourth quarter of 2024, Fabhalta generated sales of $57 million. In addition to Fabhalta, Novartis is advancing the late-stage development of two additional IgAN therapies with highly differentiated mechanisms of action: atrasentan, an investigational oral endothelin A receptor antagonist that received FDA filing acceptance in Q2 2024 with a decision anticipated in H1 2025, and zigakibart, an investigational subcutaneously administered anti-APRIL monoclonal antibody currently in Phase 3 development. Price Action: NVS stock is down 0.45% at $112.70 at the last check Friday. Read Next:Photo by Taljat David via Shutterstock Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? This article FDA Approves Expanded Use Of Novartis Rare Disease Drug As Only Treatment For Rare Type Of Kidney Disease originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Sign in to access your portfolio
