It is always exciting to see the onset of a new clinical trial designed to research therapies to fill unmet needs for patients. According to a news release from biotechnology company EsoCap AG (“EsoCap”), the first patient was dosed in the Phase 2 ACESO clinical trial. During the trial, researchers will evaluate the safety, efficacy, and tolerability of ESO-101 for adults with eosinophilic esophagitis (EoE).
Eosinophilic Esophagitis (EoE)
Eosinophilic esophagitis (EoE) is a chronic immune/allergic disorder which affects the esophagus. In patients with EoE, large numbers of eosinophils (a type of white blood cell) collect in the esophagus. This results from immune hypersensitivity to foods or environmental allergens. Normally, eosinophils play a role in immune response by fighting infections. High numbers of eosinophils correlate with allergic diseases or reactions. In large numbers, eosinophils also cause inflammation. Many patients with EoE also have other allergic conditions, such as eczema or asthma. Symptoms and characteristics associated with EoE include:
- Nausea and vomiting
- Appetite loss
- Recurring abdominal pain
- Poor growth
- Unintended weight loss
- Malnutrition
- Difficulty swallowing
- Food impaction
ESO-101
So what exactly is ESO-101, and how could it improve care for patients with EoE? Currently, it can be difficult to effectively topically treat the esophagus due to the short contact time between when the drug is taken and when it reaches the stomach. Currently, the standards-of-care for EoE include dietary modifications, feeding tubes, or steroids to treat inflammation. However, it can be difficult to treat the underlying biological causes of EoE.
ESO-101 aims to overcome current barriers to treatment by delivering a longer contact time between the therapy and the esophageal mucosal surface. The treatment consists of a capsule filled with mometasone furoate, a mucoadhesive fill, soluble retainer, and sinker. First, the capsule holder is screwed into a drinking cup lid. As the patient drinks from the cup, the mucoadhesive film unrolls and binds to the esophagus. By the time the film dissolves, it has been in contact with the mucosa for ~15 minutes, increasing contact time. ESO-101 earned Orphan Drug designation from the FDA. This designation is granted to drugs or products intended to treat, prevent, or cure rare diseases (those affecting under 200,000 Americans).
