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EsoCap to Present Key Phase II Results on Novel Drug Delivery System in Eosinophilic Esophagitis at DDW 2025

April 22, 2025 – Biotechnology, Clinical Trials, Drug Delivery, Drug Discovery, Pharmaceutical – Digestive Disease Week 2025, EsoCap Biotech, clinical trials, eosinophililc esophagitis, gastrointestinal diseases, targeted drug delivery

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.

22 April 2025 — Basel, Switzerland — 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 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