A Phase 2 Multicenter Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy Safety Tolerability and Pharmacodynamic Effect of AK002 in Patients with Eosinophilic Gastritis with or without Eosinophilic Gastroenteritis

Eosinophilic gastrointestinal disorders (EGIDs) are chronic inflammatory disorders characterized by infiltration of eosinophils along different segments of the gastrointestinal (GI) tract, in the absence of any cause of the eosinophilia (Caldwell, 2014).There are no FDA-approved treatments for EG or EGE. Current therapies and disease management include proton pump inhibitors, antihistamines, restricted/elemental diets, systemic or oral corticosteroids, and occasional off-label use of immunomodulatory biologics (Prussin, 2014; Reed, 2015; Zhang, 2017). Proton pump inhibitors have little to no benefit in patients with EG or EGE, although partial benefit is observed in patients with EoE (Katz, 2013). Restricted/elemental diets are not considered sustainable for long-term treatment and are used more so to provide nutrition, despite continuing symptoms. Corticosteroids, systemic or oral, can provide symptom relief, but are not a solution for long-term treatment due to their numerous side effects. By reducing the number of blood and tissue eosinophils and reducing the number and/or activation of tissue mast cells, AK002 may be useful in the treatment of patients with EG ± EGE.