Our approach is to show the clinical proof of concept for our unique drug delivery technology in one indication and to seek for a major partner within the biopharmaceutical industry.
First Indication: Eosinophilic Esophagitis
The lead indication is eosinophilic esophagitis (EoE), a rare inflammatory disease of the esophagus, with no worldwide approved treatment option at this stage. The symptoms of EoE include swallowing disorders, food impaction, vomiting, and heartburn. The only treatment options for the condition are extremely strict diets, off-label treatment with steroids or off-label proton pump inhibitors, an orodispersible budesonide tablet available only in limited territories or a monoclonal antibody that is administered subcutaneaously.
These treatment options remain suboptimal for the vast majority of affected patients.
EsoCap’s lead product will ensure a long-lasting topical delivery of mometasone, a well-established and highly potent locally acting steroid. It has the potential to establish a new standard of care and majorly improve the lives of affected people.
Positive topline results from ACESO Phase II trial investigating ESO-101 in eosinophilic esophagitis
The ACESO trial is a randomised, placebo-controlled, double-blind Phase II study in which ESO-101 was compared with placebo in 43 patients in five countries. The ACESO study met its primary endpoint with a statistically significant reduction in peak eosinophil counts on histological evaluation of oesophageal biopsies, confirming superiority over placebo with a p-value <0.05. Patients receiving ESO-101 experienced a 50% reduction in eosinophil counts, while patients receiving placebo experienced no change from baseline, demonstrating a significant difference between the efficacy of active treatment and placebo control.
The study also showed that ESO-101 has a very favourable safety and tolerability profile. 7.1% (n=2) of patients treated with ESO-101 and 26.7% (n=4) in the placebo group reported mild to moderate adverse events related to the investigational product.
These results mark an important milestone for EsoCap and represent a substantial value inflection point.