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Eosinophilic Esophagitis

Eosinophilic Esophagitis (EoE) is a rare, chronic allergic inflammatory disease characterized by eosinophilic infiltration of the esophagus. 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 or glucocorticoid steroid formulations, and injections of a biologic monoclonal antibody. Despite growing awareness of the condition and its underserved patient population, no orally administered FDA approved treatments are available.

APT-1011

APT-1011 is a novel, once daily, oral disintegrating tablet designed specifically to deliver fluticasone propionate to the esophageal mucosa to exert local anti-inflammatory effects with low systemic absorption. The successful completion of FLUTE 1 (Phase 2b study) and FLUTE 2 (Phase 3 study) has facilitated the initiation of FLUTE 3 (ongoing second Phase 3 study). APT-1011 has received Orphan Drug Designation from the FDA and the European Medicines Agency (EMA), and also received Fast Track Designation from the FDA in 2021. This designation was granted based on data evaluating histological remission and symptomatic improvement after 12 weeks of treatment (induction), and the long-term maintenance of these improvements.

Pipeline

Disease

Drug

Discovery

Preclinical

Phase 1 Trial

Phase 2 Trial

Phase 3 Trial

Eosinophilic Esophagitis

APT-1011

Eosinophilic Esophagitis

Esomeprazole ODT