Latest news with #62ndERACongress
Yahoo
4 days ago
- Business
- Yahoo
Vivoryon Therapeutics N.V. Presents Meta-analysis Data of VIVIAD and VIVA-MIND studies at ERA 2025
Vivoryon Therapeutics N.V. Vivoryon Therapeutics N.V. Presents Meta-analysis Data of VIVIAD and VIVA-MIND studies at ERA 2025 Halle (Saale) / Munich, Germany, June 6, 2025 – Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company developing small molecule medicines for inflammatory and fibrotic disorders, with a primary focus on kidney diseases, today announced that meta-analysis data for its lead drug in development, varoglutamstat, was presented at the 62nd ERA Congress of the European Renal Association in Vienna, Austria, today, June 6, 2025. 'We are delighted that the results of the Phase 2 program were accepted for presentation at the ERA 2025 congress. This allowed Vivoryon to share the outstanding improvements of varoglutamstat on kidney function (eGFR) with the scientific and medical expert community in the kidney space,' said Frank Weber, MD, CEO of Vivoryon. Presentation Highlights Varoglutamstat is a first-in-class glutaminyl cyclase (QPCT/L) inhibitor with potent anti-inflammatory and anti-fibrotic effects. VIVIAD and VIVA-MIND, two independent Phase 2 studies in the EU and U.S. showed a statistically significant and clinically meaningful improvement in a prospectively defined kidney function parameter, eGFR, in an elderly patient population. This improvement was consistent in both trials independently, replicated in the meta-analysis and pooled analysis, and provides converging evidence for this finding. Statistically significant differences between varoglutamstat and placebo were first observed at week 24 and were sustained until week 96. The meta-analysis also confirmed a substantially larger effect size in study participants with diabetes compared to those without diabetes. The next step is planned to be a dedicated Phase 2b trial in patients with diabetic kidney disease (patients with diabetes and chronic kidney disease stage 3b/4). The main goal will be to investigate the efficacy on eGFR in this patient population and to obtain additional information on a potential effect on proteinuria and other kidney specific markers. Presentation Details Date: June 6, 2025 Presentation time: 8:15 am CEST as part of the focused oral session Title: Varoglutamstat improves eGFR and offers a new approach to treat diabetic kidney disease (DKD): meta-analysis from two independent Phase 2 studies Venue: Vienna, Austria Presenter: Frank Weber, MD, CEO of Vivoryon Therapeutics ### About Vivoryon Therapeutics N.V. Vivoryon is a clinical stage biotechnology company focused on developing innovative small molecule-based medicines for the treatment of inflammatory and fibrotic disorders of the kidney. Driven by its passion for ground-breaking science and innovation, the Company strives to improve patient outcomes by changing the course of severe diseases through modulating the activity and stability of pathologically relevant proteins. Vivoryon's most advanced program, varoglutamstat, a proprietary, first-in-class orally available QPCT/L inhibitor, is being evaluated to treat diabetic kidney disease.
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.
