Candidate ESO-101 will treat participating patients across five European countries
EsoCap, a company focused on improving the lives of patients with serious diseases of the upper gastrointestinal tract, has completed patient recruitment for its phase 2 ACESO clinical trial.
The placebo-controlled, double-blind, randomised research is evaluating the tolerability, efficacy and safety of candidate ESO-101 among 43 adult patients with active eosinophilic esophagitis (EoE) across five European countries. The participants are due to be treated for 28 days.
ESO-101 contains mometasone furoate, an anti-inflammatory corticosteroid and active pharmaceutical ingredient that is already approved for the treatment of asthma and skin conditions.
Following consumption of the capsule, through a specifically developed drinking cup, the film unrolls and adheres to the patient's oesophageal mucosa, where it gradually dissolves, releasing mometasone furoate in the process.
In a previous study in healthy volunteers, EsoCap's targeted delivery technology for the upper gastrointestinal tract demonstrated considerably increased contact times with the mucosa and was also well tolerated.
Dr Alfredo Lucendo, coordinating principal investigator for the ACESO trial, reflected: “EoE is a chronic disease with few therapeutic options. This limitation in treatment arises from the distinctive anatomical and functional attributes of the oesophagus, which result in an exceedingly brief transit period within the oesophageal tract. As a result, achieving effective topical treatment for the oesophagus presents a significant challenge.
“We are confident that ESO-101 holds the promise via increased mucosal contact time of enhancing the efficacy of drugs within the oesophagus, thereby providing significant advantages to individuals suffering from EoE.”
Isabelle Racamier, chief executive officer at EsoCap, concluded: "Reaching completion of patient enrolment reflects the high level of interest in our clinical development programme.
“Our technology is highly flexible. Multiple relevant agents, including biologics and other innovative compounds, can be incorporated into the film, making our drug delivery platform suitable for several clinical indications, including reflux disease, Barrett’s disease and oesophageal cancer – all areas of high unmet medical need.”
EoE is a rare, chronic disease characterised by oesophageal dysfunction. Symptoms of the condition include swallowing disorders, vomiting and heartburn. Around half a million patients suffer from this disease across the world.