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Eosinophilic Esophagitis

Eosinophilic Esophagitis or “EoE” is a chronic and rare disease. EoE prevalence rate in the US is estimated at 57 in 100,000 (Dellon E et al. 2017) and is evolving due to increasing awareness of the disease. The exact cause of EoE is unknown, however it is believed to be triggered by a variety of stimuli, including certain foods and environmental allergens. Symptoms of EoE in adults include dysphagia (difficulty or discomfort in swallowing) and, in severe cases, food impaction (obstruction of the esophagus by food) and strictures (narrowing of the esophagus due to scar tissue formation). Early diagnosis and treatment of EoE is important to prevent progression to fibrotic changes in the esophagus which may be only partially reversible. Current management of EoE includes food elimination diets, off label use of proton pump inhibitors, and glucocorticoid steroid formulations. In the United States, there are no FDA approved oral therapies for the treatment of EoE.

APT-1011

APT-1011 is a novel, proprietary, once daily, investigational oral disintegrating tablet designed to deliver fluticasone propionate to the esophageal mucosa while minimizing residence time in the oral cavity. In earlier clinical trials, APT-1011 reduced esophageal eosinophil counts and endoscopic findings in adults with a diagnosis of EoE. It is currently in clinical development, following successful completion of FLUTE I and FLUTE II . APT-1011, oral disintegrating tablet, has been granted orphan drug status by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Pipeline

Disease

Drug

Discovery

Preclinical

Phase 1

Phase 2

Phase 3

Eosinophilic Esophagitis

APT-1011

Eosinophilic Esophagitis

Esomeprazole ODT