Latest news with #JonathanBarratt
Yahoo
12 hours ago
- Health
- Yahoo
Calliditas Therapeutics Presented at the 62nd European Renal Association Congress
STOCKHOLM, June 9, 2025 /PRNewswire/ -- Calliditas Therapeutics (Calliditas), an Asahi Kasei company, announced today that new data was presented at the 62nd European Renal Association Congress (ERA Congress), which took place in Vienna, Austria, from June 4 to 7. The presentations included secondary analyses and new insights from biomarker from the Phase 3 NefIgArd study of Nefecon (marketed as TARPEYO® [budesonide] delayed-release capsules in the United States in patients with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression and Kinpeygo® in Europe for the treatment of adults with primary immunoglobulin A nepropathy (IgAN) with a urine protein excretion ≥ 1.0g/day (or urine protein-to-creatinine ration ≥ 0.8g/g) and in the United Kingdom for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/gram). A total of five abstracts were accepted for presentation, including one selected as a Top 10 abstract for oral presentation, along with four additional focused oral presentations. Oral Presentation Details Abstract No. 3345 – Selected as a Top 10 AbstractTitle: "Nefecon provides kidney benefit irrespective of baseline eGFR in patients with IgAN: A subanalysis of the NefIgArd study"Presenter: Jonathan Barratt, United Kingdom Focused Oral Presentation Details Abstract No. 3251Title: "Nefecon provides kidney benefit irrespective of time since diagnosis in patients with IgAN: A subanalysis of the NefIgArd study"Presenter: Richard Lafayette, United States Abstract No. 3337Title: "The NefXtend trial, investigating extended Nefecon treatment beyond 9 months in patients with IgAN"Presenter: Richard Lafayette, United States Abstract No. 2642Title: "Effects of Nefecon on Hits 1, 2, and 3 of the pathogenic cascade of IgA nephropathy: A full NefIgArd analysis"Presenter: Ishika Khan, United Kingdom Abstract No. 2651Title: "Sustainability and depth of UPCR reduction in patients with primary IgAN treated with Nefecon: A secondary analysis of the Phase 3 NefIgArd trial"Presenter: Jonathan Barratt, United Kingdom The ERA Congress is a leading international event focused on kidney health and renal science. Organized by the European Renal Association, the 2025 Congress brought together nephrologists, researchers, and healthcare professionals from across the globe for scientific sessions, interactive workshops, and networking opportunities. The event aimed to advance research, clinical care, and innovation in nephrology. About TARPEYO®/Kinpeygo®TARPEYO® is an oral 4mg delayed-release formulation of budesonide, designed to dissolve in the pH of the distal ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum, including the Peyer's patches, which are responsible for the production of galactose-deficient IgA1 antibodies (Gd-Ag1), causing IgA nephropathy. About Primary Immunoglobulin A NephropathyPrimary immunoglobulin A nephropathy (IgA nephropathy or IgAN or Berger's Disease) is a rare, progressive, chronic autoimmune disease that attacks the kidneys and occurs when galactose-deficient IgA1 is recognized by autoantibodies, creating IgA1 immune complexes that become deposited in the glomerular mesangium of the kidney. This deposition in the kidney can lead to progressive kidney damage, potentially resulting in end-stage kidney disease. IgAN most often develops between late teens and late 30s. About CalliditasCalliditas Therapeutics is a biopharma company headquartered in Stockholm, Sweden, focused on identifying, developing, and commercializing novel treatments in orphan indications with significant unmet medical needs. Visit for further information. About Asahi KaseiThe Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber business, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 50,000 employees worldwide, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Material, Homes, and Healthcare. Its Healthcare operations include devices and systems for acute critical care, and manufacture of biotherapeutics, as well as pharmaceuticals. For further information, please visit View original content to download multimedia: SOURCE Asahi Kasei Corporation 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
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
5 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
5 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.
Cision Canada
23-05-2025
- Health
- Cision Canada
England's NICE recommends FILSPARI® (sparsentan) as a treatment option for IgA nephropathy
First non-immunosuppressive dual-action therapy recommended by NICE for eligible patients with IgA nephropathy, a leading cause of kidney failure 1-3 ST. GALLEN, Switzerland, May 23, 2025 /CNW/ -- CSL Vifor is pleased to announce that the National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending that sparsentan can be used in the NHS in England as an option to treat primary IgA nephropathy in adults with a urine protein excretion of 1.0 g/day or more, or a urine protein-to-creatinine ratio of 0.75 g/g or more. 3 NICE has provided guidance to ensure that only patients responding to treatment continue. 3 The decision follows authorisation from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in April 2025. 5 What this means in practice is that there is enough evidence to show that sparsentan provides benefits and value for money, so it can be used routinely if it is considered the most suitable treatment option in this population. 3 Sparsentan must be funded in England within 90 days of final publication of this guidance 3 which is expected to be 27 June 2025. Professor Jonathan Barratt, Professor of Renal Medicine at University Leicester, UK, welcomed the NICE decision as a major advancement in the treatment of IgA nephropathy in the UK. "IgA nephropathy is a condition with an average age at diagnosis of around 40 years. 6 Due to disease progression, a patient's kidneys may fail. Treatments, such as sparsentan, that have been developed for IgA nephropathy are urgently needed, our goal being to improve outcomes for these patients." IgA nephropathy is characterised by the buildup of a faulty version of immunoglobulin A (IgA), which accumulates in clusters in small blood vessels in the kidney, called glomeruli, that filter the blood. These clumps damage the glomeruli causing leakage of blood (haematuria) and protein (proteinuria) into the urine resulting in a progressive loss of kidney function. Proteinuria is a major risk factor for IgA nephropathy progression, increasing the risk of kidney failure. 6-8 Despite current treatments, some patients with IgA nephropathy do not achieve adequate proteinuria reduction and remain at risk of progression. 9 Although classified as rare, IgA nephropathy is the most common type of primary glomerular disease worldwide, with over 22,000 adults estimated to have the condition in England. 10 Patients generally face a poor prognosis if the condition is not appropriately controlled, with approximately 30-40% of patients developing kidney failure within 10 years of diagnosis. 11 Current medical treatment guidelines by KDIGO (Kidney Disease, Improving Global Outcomes) state that patients who are at high risk of progressive chronic kidney disease, despite maximal supportive care, are those with persistent urine protein excretion >1 g/day. 12 Underscoring the importance of the NICE recommendation for IgA nephropathy patients and their communities, Dr. Vinicius Gomes De Lima, Head of Global Medical Affairs at CSL Vifor said: "We are very pleased that NICE recognised the value of our innovative therapy which helps to address a clear unmet medical need in patients with IgA nephropathy. We look forward to working with the National Health Service to ensure access to this important medicine as soon as possible as we continue to deliver on our promise to patients." CSL Vifor expects to launch sparsentan in the UK in the second half of 2025; commercial stock will be available from July 2025. Notes to Editors On 15th April 2025, the MHRA granted the marketing authorisation for sparsentan based on the final results of the Phase 3 PROTECT double blind study. 5 About CSL Vifor CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. We specialise in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care). The parent company, CSL (ASX: CSL; USOTC: CSLLY), headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries. For more information about CSL Vifor visit, About IgA nephropathy Primary immunoglobulin A nephropathy (IgA nephropathy) is a rare, progressive type of chronic kidney disease (CKD) that is often diagnosed in adults before the age of 40 years. 6 CKD is characterised by abnormalities of kidney function or structure that have been present for more than three months and can be categorised into five stages dependent on functionality of the kidney. 13 Dialysis (a medical treatment used to artificially filter waste products and excess fluids from the blood when the kidneys are unable to perform this function adequately) 14 or kidney transplantation is recommended for patients whose kidneys have reached an advanced stage (typically, stage 5). 15 More than 60 per cent of adult patients diagnosed with IgA nephropathy are in CKD stage 3 or higher. 6 Patients with this condition may experience blood in the urine (red or dark brown urine), foamy urine from protein leaking into the urine, flank pain, swelling (oedema), high blood pressure, and fatigue. 16 About FILSPARI ® (sparsentan) Sparsentan was developed by Travere Therapeutics and has been granted Orphan Drug Designation for the treatment of IgA nephropathy in the UK, Europe and the U.S. Sparsentan is currently available in the U.S. and first markets in Europe. CSL Vifor has been granted exclusive commercialisation rights for sparsentan in Europe, Australia and New Zealand. Sparsentan is anticipated to be available to patients in the UK in the second half of 2025. Sparsentan is the first and only non-immunosuppressive treatment for IgA nephropathy that has two modes of action. 1 This single molecule functions as a high affinity, dual-acting antagonist of both the endothelin A receptor (ETAR) and the angiotensin II subtype 1 receptor (AT1R). 4 Sparsentan inhibits activation of both ETAR and AT1R, both of which play a role in regulating processes in the kidney, such as inflammation, that lead to progression of kidney damage. 4 About PROTECT NICE's recommendation is based on data from the pivotal Phase 3 PROTECT study 4 of sparsentan in IgA nephropathy, one of the largest interventional studies to date in IgA nephropathy and the only head-to-head trial in this rare kidney disease. It is a global, randomised, multicentre, double-blind, parallel-arm, active-controlled clinical trial evaluating the safety and efficacy of 400 mg of sparsentan, compared to 300 mg of irbesartan (an angiotensin II receptor blocker(ARB)), in 404 patients ages 18 years and up with IgA nephropathy and persistent proteinuria despite receiving at least 50% of maximum label dose and maximally tolerated angiotensin-converting enzyme (ACE) inhibitors or ARB therapy. 4,17 The PROTECT study met its primary endpoint at the pre-specified interim analysis with statistical significance. 4 After 36 weeks of treatment, patients receiving sparsentan (n=202) achieved a mean reduction in proteinuria from baseline of 49.8 percent, compared to a mean reduction in proteinuria from baseline of 15.1 percent for irbesartan-treated patients (n=202). 4,17 Treatment emergent adverse events and serious adverse events were well-balanced between sparsentan and irbesartan, except for dizziness (30 [15%] vs 13 [6%] patients) and hypotension (26 (13%] vs eight (4%] patients). 4 For more information, please refer to the Summary of Product Characteristics (SmPC). 18,19 References: Trachtman H, et al. Sparsentan: the first and only non-immunosuppressive therapy for the reduction of proteinuria in IgA nephropathy. Expert Rev Clin Immunol. 2024 Jun;20(6):571-576. doi: 10.1080/1744666X.2024.2319132. Komers R, et al. Dual inhibition of renin-angiotensin-aldosterone system and endothelin-1 in treatment of chronic kidney disease. Am J Physiol Regul Integr Comp Physiol. 2016 May 15;310(10):R877-84. doi: 10.1152/ajpregu.00425.2015. NICE Draft Final Guidance on sparsentan (May 2025). Rovin BH, et al. Efficacy and safety of sparsentan versus irbesartan in patients with IgA nephropathy (PROTECT): 2-year results from a randomised, active-controlled, phase 3 trial. Lancet. 2023 Dec 2;402(10417):2077-2090. doi: 10.1016/S0140-6736(23)02302-4. Travere Therapeutics and CSL Vifor Announce Standard EU Approval of FILSPARI® (sparsentan) for IgA Nephropathy; press release (April 2025). Pitcher D, et al. Long-Term Outcomes in IgA Nephropathy. Clin J Am Soc Nephrol. 2023;18(6):727– Reich HN, et al. Remission of proteinuria improves prognosis in IgA nephropathy. J Am Soc Nephrol. 2007;18:3177–83. Sharma S, et al. From Proteinuria to Fibrosis: An Update on Pathophysiology and Treatment Options. Kidney Blood Press Res. 2021;46:411−20. Bagchi S, et al. Supportive Management of IgA Nephropathy With Renin-Angiotensin Blockade, the AIIMS Primary IgA Nephropathy Cohort (APPROACH) Study. Kidney Int Rep. 2021 Feb 26;6(6):1661-1668. doi: 10.1016/ PMID: 34169207; PMCID: PMC8207308. European Medicines Agency (EMA). (2020) Orphan designation for the treatment of primary IgA nephropathy (accessed May 2025). Barratt J, et al. Therapy of IgA nephropathy: time for a paradigm change. Front Med (Lausanne). 2024 Aug 15;11:1461879. doi: 10.3389/fmed.2024.1461879. PMID: 39211339; PMCID: PMC11358106. KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Disease, Kidney International (2021) 100, S1-S276 (accessed May 2025). NKF Kidney Disease Stages (accessed May 2025). NKF Haemodialysis (accessed May 2025). NKF Transplants for All NKUK Transplantation (accessed May 2025). Mayo Clinic What is IgA Nephropathy? (accessed May 2025). Heerspink HJL, et al. PROTECT Investigators. Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial. Lancet. 2023 May 13;401(10388):1584-1594. doi: 10.1016/S0140-6736(23)00569-X. Epub 2023 Apr 1. PMID: 37015244. Filspari EU131-SmPC_SPT_UK_200mg UK SmPC (May 2025). Filspari EU131-SmPC_SPT_UK_400mg UK SmPC (May 2025). CSL Vifor Media Contact Job no: UK-SPT-25000110 Date: 23 May 2025
