Pharma Focus Europe

Esocap Achieves Full Patient Enrollment in Phase II ACESO Trial for Eosinophilic Esophagitis

Tuesday, September 05, 2023

Swiss biotech company EsoCap AG has announced the successful completion of patient recruitment for the Phase II ACESO trial. This study is a randomized, placebo-controlled, double-blind investigation into the efficacy, tolerability, and safety of their product candidate, ESO-101, in 43 adult patients from five European countries who suffer from active eosinophilic esophagitis (EoE). EoE is a rare, chronic immune-mediated esophageal disorder characterized by symptoms such as difficulty swallowing, food blockages, heartburn, and vomiting, as well as histological inflammation marked by eosinophil predominance.

ESO-101 is the first product candidate by EsoCap, which incorporates mometasone furoate, a well-established anti-inflammatory corticosteroid used in treating asthma and skin conditions. It is an ideal choice for localized treatment of EoE. When ingested via a specially designed capsule and drinking cup, the film within the capsule unfolds and adheres to the esophageal mucosa, gradually releasing mometasone furoate. The ACESO Phase II trial aims to assess the effectiveness of ESO-101 by evaluating histological response and clinical symptoms.

Isabelle Racamier, CEO of EsoCap AG, expressed excitement about completing patient enrollment and the anticipation of forthcoming data, which will inform their strategic development plans. She emphasized the versatility of their technology, which can accommodate various therapeutic agents, including biologics, making it suitable for addressing multiple clinical indications like reflux disease, Barrett's disease, and esophageal cancer—areas with substantial unmet medical needs.

Dr. Alfredo J. Lucendo, the coordinating principal investigator of the ACESO trial from the Department of Gastroenterology at Hospital General de Tomelloso, Spain, highlighted the challenges in treating EoE due to the unique characteristics of the esophagus. He expressed confidence that ESO-101, with its extended mucosal contact time, holds promise for improving treatment outcomes for individuals with EoE.

Previously, EsoCap's proprietary targeted delivery technology for the upper gastrointestinal tract demonstrated increased mucosal contact time and good tolerability in healthy volunteers.

EoE is a rare, chronic immune-mediated esophageal condition characterized by symptoms related to esophageal dysfunction and histological eosinophil-predominant inflammation. It affects children and young adults and is a leading cause of dysphagia and food impaction.

Current treatment options for EoE include strict diets, off-label steroid treatment, off-label proton pump inhibitors, and a limited availability orodispersible budesonide tablet. These options remain suboptimal for most patients, and EoE affects approximately half a million individuals worldwide, with increasing incidence with age.

The ACESO trial is a Phase II clinical study that involves multiple centers and evaluates the efficacy, tolerability, and safety of ESO-101 in adult patients with active EoE. Patients receive daily treatment for 28 days.

The primary objective of the trial is to assess efficacy based on histological response, with secondary objectives including clinical symptom improvement, endoscopic response, patient-reported outcomes, treatment satisfaction, as well as safety and tolerability.

The EsoCap system is an innovative drug delivery system for the upper gastrointestinal tract, comprising a capsule holder with a thin mucoadhesive film rolled inside a hard gelatin capsule, along with a sinker and a soluble retainer. This capsule holder is attached to a drinking cup lid to facilitate swallowing during ingestion. After swallowing, the film unrolls and adheres to the esophageal mucosa, where it dissolves, ensuring a contact time of up to 15 minutes. This extended contact time far surpasses that of conventional pharmaceutical forms like orodispersible tablets, which have contact times of less than one minute.

ESO-101, containing mometasone furoate, was designed as an esophagus-specific drug formulation and delivery system to maximize mucosal contact and optimize esophageal deposition of the active ingredient. Clinical trials have shown mometasone furoate to be effective in reducing esophageal eosinophilic inflammation and improving clinical symptoms in EoE patients. ESO-101 offers the potential for significant clinical benefits in EoE treatment.

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