Clinical Trial: Safety and Efficacy of a Novel Oesophageal Delivery System for Topical Corticosteroids Versus Placebo in the Treatment of Eosinophilic Oesophagitis

Lucendo AJ, Nantes-Castillejo Ó, Straumann A, Biedermann L, Bredenoord AJ, Guagnozzi D, Blas-Jhon L, Wiechowska-Kozlowska A, Weidlich S, von Arnim U, Santander-Vaquero C, Perelló A, Pérez-Martínez I, Barrio J, Vieth M, Gouya G, Dellon ES (2025)

Publication Type: Journal article

Publication year: 2025

Journal

Alimentary Pharmacology & Therapeutics Wiley-Blackwell

Book Volume: 61

Pages Range: 444-455

Journal Issue: 3

DOI: 10.1111/apt.18443

Abstract

Background: EsoCap is a thin mucoadhesive film designed to target the oesophageal mucosa. The device loaded with mometasone furoate (ESO-101) is under investigation for the treatment of eosinophilic oesophagitis (EoE). Aims: To evaluate the efficacy, safety and tolerability of ESO-101 in patients with active EoE. Methods: We conducted a randomised, placebo-controlled, phase 2, proof-of-concept trial at 14 European sites in adults with EoE. Participants received placebo, uncoated EsoCap (n = 15), or EsoCap loaded with 800 μg of mometasone furoate (n = 28) once daily during 28 days. The primary outcome was the absolute change in the peak eosinophil count; secondary outcomes were histologic, clinical and endoscopic measures. Results: Treatment with ESO-101 resulted in reduction (mean ± SD) of 49.1 ± 88.4 eosinophils/high-power field from baseline, compared with 6.6 ± 65.1 with placebo (p = 0.03). With ESO-101, 48% and 44% of patients achieved < 15 and < 6 eosinophils/high-power field, respectively; these were 0% with placebo. EoE Endoscopic Reference Score reduced significantly in patients treated with ESO-101. In contrast, dysphagia and odynophagia severity decreased similarly in both groups. There were no serious treatment-emergent adverse events. Mean serum cortisol did not change significantly throughout the trial. Notably, no oropharyngeal or oesophageal candidiasis was documented. The device was well tolerated. Conclusions: ESO-101 was superior to placebo in reducing oesophageal eosinophilia. The device was safe and well tolerated in adults with EoE, supporting the continued development of ESO-101 for the treatment of EoE (Trials.gov No.: NCT04849390; Eu-CT No.: 2020–000082-16).

Authors with CRIS profile

Michael Vieth Medizinische Fakultät

Involved external institutions

Public General Hospital Tomelloso / Hospital General de Tomelloso ES Spain (ES) Hospital Universitario de Navarra ES Spain (ES) Universitätsspital Zürich (USZ) CH Switzerland (CH) Amsterdam University Medical Centers (Amsterdam UMC) / Amsterdam Universitair Medische Centra NL Netherlands (NL) Centro de Investigación Biomédica en Red - Enfermedades Hepáticas y Digestivas (CIBERHD) ES Spain (ES) Fundación Jiménez Díaz ES Spain (ES) Klinikum rechts der Isar DE Germany (DE) Universitätsklinikum Magdeburg A.ö.R. DE Germany (DE) Hospital de Viladecans ES Spain (ES) Central University Hospital of Asturias ES Spain (ES) Gouya Insights AT Austria (AT) University of North Carolina at Chapel Hill US United States (USA) (US)

How to cite

APA:

Lucendo, A.J., Nantes-Castillejo, Ó., Straumann, A., Biedermann, L., Bredenoord, A.J., Guagnozzi, D.,... Dellon, E.S. (2025). Clinical Trial: Safety and Efficacy of a Novel Oesophageal Delivery System for Topical Corticosteroids Versus Placebo in the Treatment of Eosinophilic Oesophagitis. Alimentary Pharmacology & Therapeutics, 61(3), 444-455. https://doi.org/10.1111/apt.18443

MLA:

Lucendo, Alfredo J., et al. "Clinical Trial: Safety and Efficacy of a Novel Oesophageal Delivery System for Topical Corticosteroids Versus Placebo in the Treatment of Eosinophilic Oesophagitis." Alimentary Pharmacology & Therapeutics 61.3 (2025): 444-455.

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