- Detailed results of the ACESO Phase II study published in the peer-reviewed medical journal Alimentary Pharmacology & Therapeutics
- ESO-101 leverages EsoCap’s unique drug delivery technology to achieve localized treatment of the esophageal lining with the anti-inflammatory corticosteroid mometasone furoate
BASEL, Switzerland, Dec. 17, 2024 (GLOBE NEWSWIRE) -- EsoCap AG, the Swiss biotech company dedicated to improving the lives of patients with serious diseases of the upper gastrointestinal tract, announced today that the complete results of the ACESO Phase II study evaluating ESO-101 for the treatment of eosinophilic esophagitis have been published in Alimentary Pharmacology & Therapeutics1. The data demonstrate that ESO-101 was safe and well tolerated and improved both histologic and endoscopic outcomes in adults with active eosinophilic esophagitis (EoE). EoE is a chronic, local, immune-mediated esophageal disease characterized clinically by symptoms associated with esophageal dysfunction, including dysphagia (i.e., swallowing difficulties), food impaction, heartburn and vomiting, and histologically by eosinophil-dominated inflammation.
The ACESO study was a randomized, placebo-controlled, double-blind Phase II study to evaluate the safety, tolerability, and efficacy of ESO-101 in adult patients with active EoE. ESO-101, EsoCap’s lead product candidate, consists of a capsule with a rolled-up, thin mucoadhesive film with the anti-inflammatory corticosteroid mometasone furoate. The study was conducted at 14 medical centers in five European countries and enrolled 43 participants with EoE and a peak eosinophil count of ≥15 eosinophils per high-power field (hpf). Patients were randomized in a 2:1 ratio and treated with ESO-101 or placebo once daily for 28 days.
The ACESO trial met its primary endpoint with a statistically significant reduction of the peak eosinophil count from baseline in histology samples. In the ESO-101 group, the mean reduction was 49.1 ± 88.4 eosinophils/hpf (p=0.0318). In addition, while none of the patients from the placebo group achieved histological remission, 48% and 44% of patients achieved <15 and <6 eosinophils/hpf, respectively, when treated with ESO-101 (p=0.0028 and p=0.0035, respectively). Patients treated with ESO-101 had a significant response in the eosinophilic esophagitis endoscopic reference score (EREFS) scores, indicating promising potential for remodeling effects despite the short treatment duration. A significant improvement of dysphagia symptoms was observed after a 4-week period with a high placebo response: a benefit of ESO-101 in relieving EoE dysphagia and odynophagia symptoms is expected to be seen in future clinical trials with a longer treatment period.
Importantly, ESO-101 also demonstrated a highly favorable safety and tolerability profile with a notable absence of oral and oropharyngeal as well as esophageal candidiasis, which is commonly observed with topical corticosteroid treatment. Compliance was high, with 100% in the ESO-101 and 93% in the placebo groups. The high level of patient satisfaction with the handling of the study medication underlines the user-friendliness of the ESO-101 drug-delivery system.
“The detailed results of the ACESO trial provide robust evidence for the efficacy and safety of ESO-101, a novel drug delivery device for the long-lasting, targeted delivery of the anti-inflammatory corticosteroid mometasone furoate directly to the esophageal mucosa,” said Dr. Alfredo J. Lucendo, Department of Gastroenterology, Hospital General de Tomelloso, Spain, and coordinating principal investigator of the ACESO trial. “The trial’s rigorous design demonstrated significant improvements in inflammatory, histological, and endoscopic parameters compared to placebo, which underscores the potential of this treatment approach. For patients with eosinophilic esophagitis, this approach offers the potential for more effective disease management in a field where treatment options are scarce.”
“At EsoCap, we are committed to transforming the lives of patients affected by esophageal diseases. The positive outcome of the ACESO Phase II study with ESO-101 and the publication in a peer-reviewed journal are an important validation of our targeted, topical delivery platform, which has been designed to increase mucosal contact time and drug deposition in the esophagus,” said Isabelle Racamier, CEO of EsoCap. “This marks an important milestone for EsoCap in advancing treatment options for eosinophilic esophagitis.”
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 minutes2,3, 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 is a privately funded company based in Basel, Switzerland.
EsoCap’s vision is to improve the lives of patients with serious diseases of the upper gastrointestinal tract through development of a unique and innovative topical drug delivery platform.
Effective topical treatment of the esophagus is extremely difficult to achieve with the current standard of care, due to the ultra-short drug contact time of 45 seconds from the mouth to the stomach. Lead candidate ESO-101 has received Orphan Drug Designation from the U.S. Food & Drug Administration (FDA) for the treatment of EoE and is in clinical development for this indication.
EsoCap has developed a unique, proprietary drug delivery platform enabling the efficient topical application of drug substances for the local treatment of diseases of the upper gastrointestinal tract. EsoCap has a strong and broad intellectual property position.
For more information, please visit www.esocapbiotech.com and follow EsoCap on LinkedIn.
Contacts:
Isabelle Racamier, CEO
EsoCap AG
Malzgasse 9
4052 Basel, Switzerland
isabelle.racamier@esocapbiotech.com
Media Inquiries:
MC Services AG
Dr. Regina Lutz, Dr. Johanna Kobler
Phone: +49 89 210288-0
esocap@mc-services.eu
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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.
