UEG Week 2025: Relive the Highlights
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EoE with Alex Straumann - Part 1
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EoE with Alex Straumann - Part 2
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UEG Policy Webinar: Healthy hearts, healthy guts: Can the EU Safe Hearts Plan improve digestive health?
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GORD Pathophysiology - Part 1
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Oesophageal cancer with Massimiliano di Pietro (Part 1)
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Introduction
Eosinophilic esophagitis (EoE) is an increasingly prevalent esophageal disease resulting in dysphagia and food impaction. ESO-101 targets the esophageal mucosa by significantly increasing topical medication contact time through the slow release of mometasone furoate. This innovative application technology consists of a drug-loaded thin-film rolled up in a capsule that unravels and sticks to the esophageal mucosa when swallowed. The current proof-of-concept phase 2 study evaluated the efficacy and safety of ESO-101.
Aims & Methods
This randomized, double-blind, placebo-controlled trial (NCT04849390) investigated the safety and efficacy of ESO-101 in adult patients with EoE and dysphagia. Patients were randomized 2:1 to once-daily treatment with ESO-101 800 µg or placebo and treated for 4-weeks. The primary endpoint was the absolute change in peak eosinophil count (eos/hpf) from baseline. Secondary endpoints were the change in EoE Endoscopic Reference Score (EREFS) and dysphagia symptoms measured by the 11-point numeric rating scale (NRS). Safety was also assessed.
Results
59 patients were screened at 13 European study sites, 43 patients were randomized, and 40 (27 to ESO-101 and 13 to placebo) completed the trial. For all histological and endoscopic endpoints, ESO-101 led to a statistical improvement compared to placebo. The mean decrease in peak eosinophil count was 49.1 (±88.4) eos/hpf with ESO-101, while counts increased by a mean of 6.6 (±65.1) eos/hpf in the placebo group (p=0.0318). Mean EREFS decreased by 3.9 (±2.6) with ESO-101 and there was no change with placebo (-0.1 [2.3]) (p=0.0001). A higher proportion of patients showed a histological response (<15 eos/hpf) with ESO-101 versus placebo (48% vs 0%; p=0.0028). There was also numerical improvement in the dysphagia severity score in the ESO-101 group (median improvement in the dysphagia severity of 4 scores [relative change: -71%]) compared to placebo (improvement in 3 scores [relative change: -57%]). No cases of oropharyngeal or esophageal candidiasis were observed (Table 1).
| Table 1: Main Outcome Parameters ACESO Study | |||
|---|---|---|---|
| Outcome parameters ACESO study | ESO-101 (n=28) | Placebo (n=15) | p-value |
| Absolute change in peak eosinophil count CFB mean (SD) | -49.11 (88.42) | 6.63 (65.11) | 0.0318 |
| Histological response < 15 eos/hpf (n [%]) | 13 (48.1) | 0 (0.0) | 0.0028 |
| Histological response < 15 eos/hpf and improvement in the dysphagia severity score (n [%]) | 12 (44.4) | 0 (0.0) | 0.0035 |
| Absolute change in the EREFS CFB mean (SD) | -3.9 (2.6) | -0.1 (2.3) | 0.0001 |
| Absolute change in dysphagia severity score CFB mean (SD) | -3.2 (2.0) | -3.0 (2.2) | n.s. |
| Relative change in dysphagia severity score CFB mean (SD) | -61.46 (37.87) | -47.27 (30.36) | n.s. |
| Oropharyngeal or esophageal candidiasis (n [%]) | 0 (0) | 0 (0) | - |
| Treatment compliance defined as proportion of days IMP was taken (n [%]) | 96.44 (5.52) | 92.88 (17.12) | - |
Conclusion
ESO-101 resulted in statistically significant histologic and endoscopic improvements compared with placebo, even with the 4-week treatment duration. ESO-101 was well tolerated. The ACESO study underscores the promise of topical drug delivery to the esophagus using the ESO-101 drug delivery system and provides a robust foundation for future ESO-101 development for EoE therapy.
Disclosure
- Lucendo AJ: Principal Investigator of the ACESO Study sponsored by EsoCap Biotech AG
- Dellon ES: Consultant to EsoCap Biotech AG
- Bredenoord AJ: Investigator of the ACESO study sponsored by EsoCap Biotech AG
- Straumann A: Consultant to EsoCap Biotech AG
- Racamier I: CEO of EsoCap Biotech AG
- Ghazaleh Gouya-Lechner: Medical Advisor of EsoCap Biotech AG
A NOVEL DELIVERY-SYSTEM FOR TOPICAL EOSINOPHILIC ESOPHAGITIS TREATMENT WITH MOMETASONE FUROATE: RESULTS OF THE PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED ACESO-TRIAL
Alfredo J. Lucendo 1, Evan S. Dellon 2, Arjan Bredenoord 3, Alex Straumann 4, Isabelle Racamier 5, Ghazaleh Gouya-Lechner 6
1 Hospital General de Tomelloso, Tomelloso, Spain
2 University of North Carolina School of Medicine, Chapel Hill, NC, United States
3 Amsterdam UMC, Amsterdam, Netherlands
4 Department of Gastroenterology, University Hospital Zurich, Switzerland, Kappel, Switzerland
5 Esocap AG, Basel, Switzerland
6 GOUYA INISGHTS GmbH &Co KG, Vienna, Austria
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COHORT PROFILE UPDATE: THE SWISS EOSINOPHILIC EESOPHAGITIS COHORT STUDY (SEECS)
Jeanine Wakim El-Khoury 1, Ekaterina Safroneeva 2, Catherine Saner 1, Jean-Benoit Rossel 3, Sven Trelle 3, Marcel Zwahlen 3, Luc Biedermann 4, Andrea Kreienbühl 5, Thomas Greuter 5, Philipp Schreiner 6, Peter Netzer 7, Annett Franke 8, Stephan Brand 8, Chantal Hasler 9, Patrick Roger Aepli 9, Emanuel Burri 10, Achim Weber 5, Christine Sempoux 1, Ruggero Biral 11, Wolfram Jochum 8, Joachim Diebold 9, Niels Willi 12, Alex Straumann 13, Alain M. Schoepfer 14
1 Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland
2 Tillotts Pharma, Rheinfelden, Switzerland
3 University of Bern, Bern, Switzerland
4 USZ Zürich, Zürich, Switzerland
5 University Hospital Zurich, Zurich, Switzerland
6 University Hospital AKH Vienna, Vienna, Austria
7 GastroZentrum Netzer AG, Bern, Switzerland
8 Kantonsspital St. Gallen, St. Gallen, Switzerland
9 Kantonsspital Luzern, Luzern, Switzerland
10 University Hospital Basel, Basel, Switzerland
11 Pathologie Länggasse, Ittigen, Bern, Switzerland
12 Kantonsspital Liestal, Liestal, Switzerland
13 University Hospital Zurich, Kappel, Switzerland
14 Lausanne University Hospital, Lausanne, Switzerland
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