EsoCap Publishes Phase II Results Showing ESO-101 Effective for Eosinophilic Esophagitis

EsoCap AG, a biotechnology firm based in Switzerland, has announced the publication of the comprehensive findings from the ACESO Phase II clinical trial in the journal Alimentary Pharmacology & Therapeutics. This trial assessed the efficacy and safety of ESO-101, an innovative treatment for eosinophilic esophagitis (EoE), using EsoCap’s proprietary drug delivery technology. EoE is a persistent, immune-mediated condition of the esophagus marked by symptoms such as difficulty swallowing, food getting stuck, heartburn, and vomiting, with inflammation predominantly driven by eosinophils.

The ACESO study was designed as a double-blind, randomized, placebo-controlled Phase II trial. It aimed to evaluate the safety and effectiveness of ESO-101 in adult patients actively suffering from EoE. ESO-101, the leading product candidate from EsoCap, comprises a capsule with a thin mucoadhesive film infused with mometasone furoate, a corticosteroid known for its anti-inflammatory properties. The trial took place across 14 medical institutions in five European nations and involved 43 participants who had a peak eosinophil count of at least 15 eosinophils per high-power field (hpf). Participants were assigned in a 2:1 ratio to receive either ESO-101 or a placebo every day for four weeks.

The trial successfully achieved its primary goal, showing a statistically significant decrease in peak eosinophil counts from baseline in histology samples. Patients treated with ESO-101 exhibited an average reduction of 49.1 eosinophils/hpf, which was statistically notable. Moreover, while none of the placebo recipients reached histological remission, 48% and 44% of those treated with ESO-101 reached levels of less than 15 and 6 eosinophils/hpf, respectively. The ESO-101 group also had a substantial response in the eosinophilic esophagitis endoscopic reference score (EREFS), indicating potential beneficial effects despite the short treatment duration.

Aside from efficacy, ESO-101 demonstrated an excellent safety profile, notably lacking side effects such as oral or esophageal candidiasis, which is often seen in corticosteroid treatments. Patient compliance was remarkably high, with 100% in the ESO-101 group and 93% in the placebo group. The ease of handling the medication was well-received by patients, highlighting the user-friendly nature of the ESO-101 delivery system.

Dr. Alfredo J. Lucendo of the Hospital General de Tomelloso, Spain, and the coordinating principal investigator of the ACESO trial, emphasized that the trial’s results provide strong evidence for the effectiveness and safety of ESO-101. He noted the substantial improvements in inflammatory, histological, and endoscopic parameters compared to placebo, underscoring the promise of this treatment method. This approach could offer more effective disease management for EoE patients, where current treatment options are limited.

Isabelle Racamier, CEO of EsoCap, expressed the company’s commitment to transforming the lives of patients with esophageal diseases. The favorable outcome of the ACESO trial and its publication in a peer-reviewed journal validate their targeted drug delivery platform, which enhances mucosal contact time and drug deposition in the esophagus. This marks a significant milestone for EsoCap in advancing treatment options for EoE.

Eosinophilic esophagitis is increasingly recognized as a chronic immune-mediated disease of the esophagus, primarily affecting young adults and children. The disease can lead to significant swallowing disorders and food impaction. Current treatments are limited and often ineffective for many patients, underlining the need for more targeted therapies like ESO-101. With approximately 500,000 people worldwide suffering from EoE, ESO-101 offers a promising new avenue for treatment.