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Clinical Trial
. 2025 Feb;61(3):444-455.
doi: 10.1111/apt.18443. Epub 2024 Dec 16.

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

Alfredo J Lucendo  1   2   3   4 , Óscar Nantes-Castillejo  5   6 , Alex Straumann  7 , Luc Biedermann  7 , Albert J Bredenoord  8 , Danila Guagnozzi  2   9 , Leonardo Blas-Jhon  10 , Anna Wiechowska-Kozlowska  11 , Simon Weidlich  12 , Ulrike von Arnim  13 , Cecilio Santander-Vaquero  2   4   14 , Antonia Perelló  15 , Isabel Pérez-Martínez  16   17 , Jesús Barrio  18 , Michael Vieth  19 , Ghazaleh Gouya  20 , Evan S Dellon  21
Affiliations
Clinical Trial

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

Alfredo J Lucendo et al. Aliment Pharmacol Ther. 2025 Feb.

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).

Keywords: corticosteroid; drug delivery; eosinophilic oesophagitis; histopathology; topical therapy.

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Conflict of interest statement

A.J.L. receives research funding from Adare/Ellodi, AstraZeneca, Dr. Falk Pharma, EsoCap, and Regeneron and serves as a consultant for Alfasigma, Arena/Pfizer, EsoCap, Dr. Falk Pharma, EsoCap, and Sanofi. O.N.C. received funding for scientific activities from Abbvie, Falk, Takeda, Adacyte, Shire, Faes‐Farma, AstraZeneca, Pfizer, Janssen. A.S. has consultant contracts Astra‐Seneca, BMS‐Receptos, Calypso, EsoCap, Falk Pharma, GSK, Pfizer, Sanofi‐Regeneron. L.B.: Advisory for Abbvie, Amgen, BMS, Falk, Janssen, Pfizer, Lilly, Takeda, Sanofi, Esocap; Speaker for Takeda, Sanofi, Abbvie, Lilly, Dr. Falk Pharma, BMS, and Pfizer. A.J.B. received research funding from BMS, Sanofi/Regeneron, SST, MMS, and Dr. Falk Pharma and received speaker and/or consulting fees from Uniquity, Laborie, Medtronic, BMS, Dr. Falk Pharma, Calypso Biotech, Eupraxia, Aqilion, Alimentiv, Sanofi/Regeneron, Uniquity, Reckitt, AlfaSigma and AstraZeneca. D.G. receives funding for scientific activities from Tillots Pharma, Falk, Takeda, Sanofi Biotechnology, Dr. Falk Pharma, Laboratorio Salvat. S.W. received speaker and/or consulting fees from Janssen, Sanofi, AstraZeneca, MSD, Tillotts, Gilead, Abbvie, Johnson&Johnson, Takeda, Dr. Falk Pharma, and BMS. U.v.A. received speaker and/ or consulting fess from BMS, Dr. Falk Pharma, Sanofi/ Regerenon, Alfasigma, Pfizer, Lilly, Abbive, Takeda, Esocap, Johnson&Johnson, Astra Zeneca. J.B. served as a speaker, as a consultant or received research or education funding from Abbvie, Takeda, Janssen, Kern Pharma and Ferring. M.V. received honoraria as speaker from Dr. Falk Pharma and Esocap. E.S.D. receives research funding from Adare/Ellodi, Allakos, Arena/Pfizer, AstraZeneca, Celldex, Eupraxia, Ferring, GSK, Meritage, Miraca, Nutricia, Celgene/Receptos/BMS, Regeneron, Revolo, Sanofi, and Shire/Takeda. He is a consultant for Abbvie, Adare/Ellodi, Akesobio, Alfasigma, ALK, Allakos, Amgen, Apollo, Aqilion, Arena/Pfizer, Aslan, AstraZeneca, Avir, Biocryst, Bryn, Calypso, Celgene/Receptos/BMS, Celldex, EsoCap, Eupraxia, Dr. Falk Pharma, Ferring, GI Reviewers, GSK, Holoclara, Invea, Knightpoint, LucidDx, Morphic, Nexstone Immunology/Uniquity, Nutricia, Parexel/Calyx, Phathom, Regeneron, Revolo, Robarts/Alimentiv, Sanofi, Shire/Takeda, Target RWE, Upstream Bio. Educational grant provided by Allakos, Aqilion, Holoclara, Invea. The remaining authors have nothing to disclose.

Figures

FIGURE 1
FIGURE 1
ACESO trial design and EsoCap drug delivery system. (A) Schema of the trial design. This was a double‐blind, randomised, placebo‐controlled trial to evaluate the efficacy, safety and tolerability of mometasone furoate administered via the EsoCap system. (B) EsoCap system. ESO‐101 is a thin, mucoadhesive film loaded with mometasone furoate, allowing for direct delivery and prolonged exposure of the corticosteroid to the oesophageal mucosa. The placebo consisted of the EsoCap system without any active ingredient in the film. Patients administered the treatment once daily for 28 days. E, endoscopy (including biopsy); FU, follow‐up; n, number of planned patients; R, randomisation.
FIGURE 2
FIGURE 2
Patient disposition according to the CONSORT flow diagram.
FIGURE 3
FIGURE 3
Change in the peak eosinophil count from baseline to EoT (full analysis set). (A) Absolute change in cell count/hpf. The bottom and top edges of the box indicate the IQR (range of values between the first and third quartile). The mean value is indicated by a diamond in the box, the median value by a line. Endpoints of whiskers display the 5th and 95th percentile. a2‐sided 2‐sample t‐test. (B and C) Proportion of patients with histological remission, defined either as (B) peak eosinophil count < 15 eosinophils/hpf or (C) peak eosinophil count < 6 eosinophils/hpf at each of the oesophageal levels. EoT, end of treatment; hpf, high‐power field; IQR, interquartile range.
FIGURE 4
FIGURE 4
Change in dysphagia and odynophagia symptoms from baseline to EoT (full analysis set). (A and B) Dysphagia was quantified in terms of absolute score values (A) and relative change from baseline (B). (C and D) Odynophagia was quantified in terms of absolute score values (C) and relative change from baseline (D). The bottom and top edges of the box indicate the IQR (range of values between the first and third quartile). The mean value is indicated by a diamond in the box, the median value by a line. Endpoints of whiskers display the 5th and 95th percentile. EoT, end of treatment; IQR, interquartile range; N, number of patients.
FIGURE 5
FIGURE 5
Proportion of patients showing both amelioration of dysphagia symptoms and histological remission (< 15 eosinophils/hpf) at EoT (full analysis set).
FIGURE 6
FIGURE 6
Change in endoscopic signs of inflammation and fibrosis from baseline to EoT (full analysis set). The endoscopic response was measured based on the EREFS. The bottom and top edges of the box indicate the IQR (range of values between the first and third quartile). The mean value is indicated by a diamond in the box, the median value by a line. Endpoints of whiskers display the 5th and 95th percentile. a2‐sided Wilcoxon rank sum test, post hoc analysis. EoT, end of treatment; EREFS, eosinophilic esophagitis endoscopic reference score; IQR, interquartile range; N, number of patients.
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References

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