Phase 3 Study of Cendakimab for Eosinophilic Oesophagitis (EoE): Key Findings Eosinophilic Oesophagitis (EoE) is a chronic oesophagus condition characterised by an excessive accumulation of eosinophils, leading to inflammation and difficulty swallowing. Recent prevalence studies reveal that EoE is far more common than previously understood, affecting 1 in 700 people—a five-fold increase since 2009. It is no longer classified as a rare disease. Current treatments include proton pump inhibitors, corticosteroids, biologics, and dietary elimination. However, the significant financial burden and the condition's impact on daily life highlight the need for more personalised and accessible treatment options. A phase 3 multicenter, multinational, randomised, double-blind, placebo-controlled, 48-week, treat-through study data suggest cendakimab may be a new option for treating EoE. Cendakimab is a recombinant, humanised, high-affinity, neutralising monoclonal antibody. It targets interleukin (IL)-13, blocking its interaction with receptors IL-13Rα1 and IL-13Rα2, thereby inhibiting the inflammatory pathways associated with EoE. At the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting in Philadelphia, Pennsylvania, Dr. Evan Dellon, MD, MPH, director of the Center for Esophageal Diseases and Swallowing at the University of North Carolina Chapel Hill, presented findings on cendakimab. The study demonstrated statistically significant improvements in symptoms and oesophageal eosinophil counts in patients treated with cendakimab over 24 weeks, with these benefits persisting through 48 weeks compared to placebo. The pathogenesis of EoE is closely linked to interleukin-13 (IL-13); therefore, targeted IL-13 inhibition may be beneficial. In a phase 2 study, cendakimab significantly reduced mean oesophagal eosinophil counts and improved other inflammatory parameters in patients with EoE. These findings prompted further evaluation of cendakimab's efficacy and safety in adults and adolescents with EoE through a Phase 3 registrational study (NCT04753697), the design of which is presented here. Dr. Evan Dellon reviewed Phase 3 data supporting the 48-week safety and efficacy of cendakimab as a treatment for EoE: Dr. Evan Dellon, MD, MPH, director of the Center for Esophageal Diseases and Swallowing at the University of North Carolina Chapel Hill: "Cendakimab is a biologic treatment that blocks the IL-13 cytokine, which drives EoE pathogenesis. This treatment was very promising in a Phase 2 trial. This study is an international, randomised, placebo-controlled trial involving 430 patients with EoE, making it one of the largest EoE studies. The study achieved the primary symptom and histological improvement outcome during the first 24 weeks. After 24 weeks, participants continued with weekly or biweekly dosing or maintained a placebo. At 48 weeks, results were sustained, with improvements in participants' oesophaguses compared to placebo. The drug was well tolerated, with no severe side effects and only minor side effects, such as pain at the injection site, similar to those experienced by participants receiving a placebo. Overall, the results are very promising for patients and healthcare providers". Learn more about the design of the study Authors: Christina M. Charriez, Sandra Zhang, Claudia H.M.C. de Oliveira, Vrunda Patel, Young S. Oh, Ikuo Hirano, Alain Schoepfer, Evan S. Dellon Read more news: Eosinophilic Diseases Research: Past, Present and Future EU Approves Dupixent® (dupilumab) as First Treatment for Young Children with EoE Eosinophilic Oesophagitis Prevalence and Costs: Key Findings from U.S. Study New Potential Tool to Evaluate EoE Severity Manage Cookie Preferences