EsoCap - Drug Delivery Platform
EsoCap owns a unique drug delivery platform allowing the topical application of drug substances for targeted and long-lasting treatment of diseases of the upper gastrointestinal tract for the first time.
The first Company to Enable Local Therapy in the Esophagus
This novel drug delivery system, designed to increase mucosal contact time and esophageal drug deposition, results in effective treatment of various esophageal diseases affecting 370 million patients, including eosinophilic esophagitis (EoE), GERD (gastrointestinal reflux disease), Barrett’s Syndrome, and esophageal cancer.
The EsoCap technology consists of a capsule containing a thin film loaded with a drug. Upon drinking the capsule from a specially designed drinking cup, the film unrolls and sticks to the patient’s esophageal mucosa, where it dissolves slowly while releasing the drug substance.
Our technology offers maximum flexibility, as multiple relevant drug substances, including biologics and further innovative compounds, can be incorporated into the thin film, making our drug delivery platform applicable to various clinical indications.
EsoCap technology has been validated at the University of Greifswald, Germany, in a functional proof of principle study in man.
The drug delivery principle’s functionality was demonstrated via MRI (magnetic resonance imaging), using the fully developed device loaded with a contrast agent. The trial showed that it is possible to deliver a mucoadhesive film to the esophagus by rolling off from a capsule during swallowing. It was found that the film rolled off in all healthy volunteers participating in the study and was correctly placed and attached to the esophageal mucosa in each single case. MRI images were generated at different time points after application. It was determined that the film is visible on the esophageal mucosa for at least 15 minutes. This is significantly longer than the contact time of less than one minute for oral orodispersible tablets (Burton et al., 1995; Washington et al., 2000). The general swallowability and acceptance were very good and no severe reactions (e.g. vomiting) were observed.
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.
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, or an orodispersible budesonide tablet available only in limited territories.
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.
EsoCap is currently conducting the ACESO Phase II clinical study in EoE. The ACESO trial is a randomised, placebo-controlled, double-blind study evaluating the efficacy, tolerability and safety of the EsoCap product, ESO-101, in adult patients with active eosinophilic esophagitis. The study is presently ongoing in 4 countries, Germany, the Netherlands, Spain and Switzerland.
The ACESO data will represent a major value inflection point and enable EsoCap to enter into a commercial transaction with a biopharmaceutical company.
Several worldwide patents owned by EsoCap have been filed.
EsoCap has filed a first patent application, with patents granted in the USA, Japan, Australia, South Africa and Russia, and expected in the EU and further strategic countries. Ring-fencing patent applications cover the capsule holder and production methods. Two additional patent applications have been filed regarding the manufacturing process.
Orphan Drug Designation (ODD)
EsoCap AG has received Orphan Drug Designation (ODD) from the United States Food & Drug Administration (FDA) for use of ESO-101 in the treatment of EoE. The FDA has recognized ESO-101’s potential to offer a significant therapeutic benefit for patients suffering from EoE. Orphan Drug Designation provides a sponsor with certain benefits and incentives, including a period of marketing exclusivity when regulatory approval is obtained for the designated indication. A similar application has been submitted in Europe.