According to a news release from Revolo Biotherapeutics, enrollment is complete for a Phase 2a proof-of-concept clinical trial. During the study, researchers will evaluate ‘1104 for eosinophilic esophagitis (EoE), a chronic allergic and immune-mediated disorder.
Revolo Biotherapeutics describes ‘1104 as being:
derived from a natural immune-regulatory protein, Mycobacterium tuberculosis Chaperonin 60.1, involved in resetting the immune system. It may provide long-term remission for many allergic diseases.
The therapy’ is able to “reset” based on its ability to reduce the inflammatory state and instead enter the immune system into a regulated, balanced, and homeostatic state. In doing so, researchers hope that the therapy would be able to reduce inflammation and other symptoms that are hallmarks of allergic conditions. While there is one FDA-approved therapy (Dupixent) for people with EoE, it is imperative to develop additional options for treatment.
Within the Phase 2a study, which focuses on adults with EoE, researchers will work to understand the safety, efficacy, and tolerability of ‘1104. Only adult patients will enroll in the trial. Currently, some data is expected to be available by the end of the year.
What is Eosinophilic Esophagitis (EoE)?
As described above, eosinophilic esophagitis (EoE) is an immune-mediated allergic disorder which affects the esophagus. Normally, eosinophils (a type of white blood cell) play a role in our immune health. These eosinophils even help fight infection! When many eosinophils collect or accumulate in one area, it may signify some sort of allergy. In people with eosinophilic esophagitis, a large amount of eosinophils are found in the esophagus. This causes inflammation, pain, and sometimes esophageal damage. EoE may be caused by immune hypersensitivity or environmental allergens, or spurred by genetic predisposition. Many people with this condition also have other allergic conditions, such as asthma or eczema. Symptoms of EoE can (but do not always) include:
- Dysphagia (difficulty swallowing)
- Food impaction (food getting stuck in the throat)
- Nausea and vomiting
- Chest pain
- Food regurgitation
- Irritability (in infants)
- Difficulty feeding or swallowing (in infants)
- Poor growth
- Unintended weight loss
- Abdominal pain
- Appetite loss