Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis

Key Inclusion Criteria:

- Male and female subjects aged ≥ 12 and ≤ 55 years;

- Written informed consent (parent or guardian must sign when applicable) and assent
form, if required;

- Evidence of eosinophilic esophagitis defined by esophageal mucosal eosinophil count
greater than or equal to 24 per HPF (400x magnification) in at least 1 of the
esophageal sites biopsied (proximal/middle and/or distal);

- Lack of histological response to previously administered high dose proton pump
inhibitor;

- Clinical symptoms of eosinophilic esophagitis with at least one of the following
symptoms: chest pain or discomfort, dysphagia (difficulty swallowing) or food
impaction.

Key Exclusion Criteria:

- Known contraindication, hypersensitivity or intolerance to corticosteroids;

- Any physical, mental, or social condition, history of illness or laboratory
abnormality that, in the investigator's judgment, might interfere with study
procedures or the ability of the subject to adhere to and complete the study;

- Oral or esophageal mucosal infection of any type;

- Any condition affecting the esophageal mucosa or altering esophageal motility other
than EoE;

- Use of systemic (oral or parenteral) or inhaled, intranasal or high-potency dermal
topical corticosteroids in the 30 days prior to the esophageal biopsy required for
entrance to this study (or prior to EGD if done during the pre-Screening period) or
at any time between the biopsy and the Randomization Visit;

- Adrenal suppression;

- Any medical condition in which the use of anti-inflammatory or immunosuppressant
drugs are required or may be anticipated to be required during the study;

- Contraindication to EGD or esophageal biopsy or narrowing of the esophagus precluding
EGD;

- History of esophageal or gastric surgery (history of esophageal dilatation is
allowed);

- Gastrointestinal bleeding;

- Current chronic infection, immunosuppression, immunodeficiency;

- History or presence of Crohn's disease, celiac disease, or other inflammatory disease
of the gastrointestinal tract;

- Alcohol or drug abuse;

- Female subjects who are pregnant or breastfeeding;

- Participation in a clinical study involving an investigational drug within 30 days of
the Screening Visit.