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

Abstract

BackgroundEsoCap 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).AimsTo evaluate the efficacy, safety and tolerability of ESO‐101 in patients with active EoE.MethodsWe 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.ResultsTreatment 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.ConclusionsESO‐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).