- New insights on safety, adherence, and patient satisfaction with ESO-101 to be presented on May 3, 2025, at DDW 2025.
- ESO-101 features EsoCap’s proprietary drug delivery technology to enable localized treatment of the esophageal lining with the anti-inflammatory corticosteroid mometasone furoate.
- The ACESO Phase II study underlines the importance of targeted drug delivery to the esophagus, reinforcing the significance of innovative approaches in the treatment of EoE.
BASEL, Switzerland, April 22, 2025 / Biotech Newswire / -- EsoCap AG today announced the highly anticipated presentation of data from the ACESO Phase II study at Digestive Disease Week (DDW) 2025, taking place May 3–6 in San Diego, USA. The oral presentation, delivered by Prof. Evan Dellon of the University of North Carolina at Chapel Hill, will highlight key findings on the safety, adherence, and satisfaction associated with EsoCap’s novel drug delivery system for eosinophilic esophagitis (EoE). This presentation is scheduled for May 3, 2025, from 4:00 to 5:30 pm in the session titled “What’s New in Eosinophilic Esophagitis?”
Advancing Targeted Therapies for EoE with ESO-101
EoE is a chronic, immune-mediated esophageal disease marked by debilitating symptoms such as dysphagia (difficulty swallowing), food impaction, heartburn, and vomiting. The ACESO study, a randomized, placebo-controlled, double-blind Phase II clinical trial, evaluated the safety, tolerability, and efficacy of ESO-101—EsoCap’s innovative esophageal drug delivery system featuring a mucoadhesive film containing the anti-inflammatory corticosteroid mometasone furoate.
Conducted at 14 medical centers across five European countries, the trial enrolled 43 adult patients with active EoE (≥15 eosinophils per high-power field). Participants were randomized in a 2:1 ratio to receive ESO-101 or placebo once daily for 28 days.
Compelling Clinical Outcomes
The ACESO trial met its primary endpoint, demonstrating a statistically significant reduction in peak eosinophil counts from baseline. ESO-101 achieved a mean reduction of 49.1 ± 88.4 eosinophils/hpf (p=0.0318). Notably, while no patients in the placebo group reached histological remission, 48% and 44% of those receiving ESO-101 achieved <15 and <6 eosinophils/hpf, respectively (p=0.0028 and p=0.0035).
Furthermore, ESO-101 treatment yielded significant reductions in eosinophilic esophagitis endoscopic reference scores (EREFS), suggesting a promising remodeling effect on esophageal tissue. Despite a short 28-day treatment period, ESO-101 also demonstrated a meaningful improvement in dysphagia symptoms, supporting its potential for long-term efficacy in future trials(1).
Exceptional Safety, Adherence, and Patient Satisfaction
Critically, ESO-101 exhibited an outstanding safety and tolerability profile, with no cases of oral, oropharyngeal, or esophageal candidiasis—common adverse effects associated with topical corticosteroid treatments. Patient compliance was remarkably high at 100% in the ESO-101 group and 93% in the placebo group. Additionally, patient-reported satisfaction underscored the ease of use and user-friendly design of the ESO-101 delivery system. Overall, a majority of patients reported being satisfied or very satisfied, with 85% in the ESO-101 group and 75% in the placebo group, based on responses to all questionnaire items.
“The ACESO trial provides compelling evidence of ESO-101’s ability to deliver sustained, targeted therapy directly to the esophageal mucosa,” said Prof. Evan Dellon, University of North Carolina at Chapel Hill, USA. “These results highlight its potential as a breakthrough treatment in EoE, leading to a high adherence with a user-friendly drug delivery system.”
Isabelle Racamier, CEO of EsoCap, expressed enthusiasm for the study’s impact: “We are thrilled that the ACESO Phase II clinical data will be showcased at DDW 2025 by Prof. Dr. Evan Dellon, a leading expert in EoE research. The significant reduction in peak eosinophil count, coupled with ESO-101’s excellent safety, adherence, and patient satisfaction, marks a major milestone in the advancement of esophageal drug delivery.”
About eosinophilic esophagitis
Eosinophilic esophagitis (EoE) is an increasingly recognized, chronic, local immune-mediated esophageal disease, characterized clinically by symptoms related to esophageal dysfunction and histologically by eosinophil-predominant inflammation. The symptoms of EoE include swallowing disorders, food impaction, vomiting, and heartburn. EoE is the leading cause of dysphagia and food impaction in children and young adults.
The only treatment options for the condition are extremely strict diets, off-label treatment with steroids or proton pump inhibitors, an orodispersible budesonide tablet available only in limited territories, or an oral suspension of budesonide approved exclusively in the USA for a short treatment duration. These treatment options remain suboptimal for the vast majority of affected patients. A monoclonal antibody targeting Th2 cell-released cytokines such as interleukin-4 (IL-4) and interleukin-13 (IL-13) was approved to treat EoE globally for steroid resistant patients. Currently, about 500,000 patients worldwide suffer from this disease. The prevalence of EoE is over 6 in 10,000. The current incidence is estimated to exceed 5 cases per 100,000. The incidence of EoE increases with age and peaks at 30-50 years of age.
About the ACESO Phase II trial
The ACESO trial was a multicenter, randomized, double-blinded, placebo-controlled clinical Phase II trial evaluating the efficacy, tolerability, and safety of ESO-101 in adult patients with active EoE. Patients were treated once daily for 28 days.
The trial’s primary objective was to evaluate efficacy based on histological response. Secondary objectives included efficacy based on 1) histological response and clinical symptoms, 2) clinical response assessed by patient-reported outcomes, and 3) endoscopic response; patient-reported treatment satisfaction; as well as evaluation of tolerability and safety.
About ESO-101
The EsoCap system is a unique drug delivery system for the upper gastrointestinal tract, consisting of a capsule holder containing a hard gelatin capsule, with a rolled, thin mucoadhesive film, a sinker, and a soluble retainer. The capsule holder is screwed onto the lid of a drinking cup to facilitate swallowing while drinking from the cup. Upon swallowing, the film unrolls and sticks to the esophageal mucosa, where it dissolves, with a contact time of 15 minutes(1,2), significantly longer than the mucosal contact time of pharmaceutical dosage forms, such as orodispersible tablets (less than one minute)(4).
The use of mometasone furoate as a swallowed aerosol formulation has been studied previously in several trials assessing its effect on EoE in adults. In these trials, mometasone furoate was shown to significantly decrease esophageal eosinophilic inflammation and improve clinical symptoms.
ESO-101 was designed as a locoregional, esophagus-adjusted drug formulation and novel delivery system to optimize mucosal contact time and maximize esophageal deposition of mometasone furoate. ESO-101 has the potential to provide significant clinical benefits to EoE patients.
About EsoCap
EsoCap AG, a privately funded company based in Basel, Switzerland, has developed a breakthrough targeted drug delivery platform for upper gastrointestinal diseases. Conventional esophageal treatments are hindered by an ultra-short drug contact time of just 45 seconds. EsoCap’s innovative technology overcomes this limitation, enabling prolonged mucosal contact and controlled drug release—key factors in enhancing treatment efficacy and patient outcomes.
The Phase II ACESO study, a double-blind, randomized, placebo-controlled trial conducted across five countries, demonstrated that ESO-101, paired with mometasone, achieved a statistically significant reduction in peak eosinophil counts (p=0.0318) in eosinophilic esophagitis (EoE). Additionally, 48% and 44% of patients achieved <15 and <6 eosinophils/hpf, respectively (p=0.0028 and p=0.0035), with an excellent safety profile—most notably, no cases of candidiasis.
ESO-101 has received Orphan Drug Designation from the U.S. FDA for the treatment of EoE, underscoring its potential as a transformative therapy in this underserved patient population.
For more information, please visit www.esocapbiotech.com and follow EsoCap on LinkedIn.
Contact
EsoCap AG
Isabelle Racamier, CEO
Malzgasse 9
4052 Basel, Switzerland
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1 Lucendo AJ, el al. Clinical trial: Safety and efficacy of a novel oesophageal delivery system for topical corticosteroids versus placebo in the treatment of eosinophilic oesophagitis. Aliment Pharmacol Ther 2025; https://doi.org/10.1111/apt.18443
2 C Rosenbaum et al, 2021. Functionality and Acceptance of the EsoCap System—A Novel Film-Based Drug Delivery Technology: Results of an In Vivo Study. Pharmaceutics, 13 (6): 828.
3 Krause et al., 2020. The EsoCap-system – An innovative platform to drug targeting in the esophagus. Journal of controlled release, 327:1–7.
4 Burton et al., 1995. Intragastric Distribution of Ion-exchange Resins: a Drug Delivery System for the Topical Treatment of the Gastric Mucosa. J. of Pharmacy and Pharmacology, 47: 901-906.
Keywords: Clinical Trials, Phase II as Topic; Drug Delivery Systems; Eosinophilic Esophagitis; Deglutition Disorders; Mometasone Furoate; Heartburn; Eosinophils; Deglutition; Eosinophilic enteropathy; Adrenal Cortex Hormones; Vomiting; Anti-Inflammatory Agents; Inflammation; EsoCap; ESO-101; Mucoadhesive film; ACESO trial; Phase II study; Digestive Disease Week; DDW 2025; Clinical trial; Esophageal mucosa; Esophageal inflammation; Endoscopic response; Dysphagia; Esophageal lining; Clinical efficacy; Local immune-mediated disease; Orphan Drug Designation; Basel; Switzerland; University of North Carolina; Prof. Evan Dellon; Controlled drug release
Source: Biotech Newswire