Eosinophilic esophagitis (EoE) is defined as a chronic, immune-mediated, atopic inflammatory condition of the oesophagus. Due to the disease’s progressive, fibrostenotic nature and the fact that patients experience a recurrent relapse when off therapy, patients may require treatment for their entire lifetime. There are currently no US Food and Drug Administration (FDA) approved treatments for EoE in the US.
Last May, the American Gastroenterological Association (AGA) partnered with the Joint Task Force (JTF) for Allergy-Immunology to publish guidelines that provide recommendations for the management of paediatric and adult patients with EoE, including therapies that should be prioritised. According to these guidelines, the first-line approach for EoE management is dietary therapy, such as the elemental, allergy-testing elimination and empiric elimination diets. The elemental diet is an elimination diet in which all sources of allergens are removed from the diet. Patients receive nutrition from an amino acid-based formula alone or, sometimes, combined with a few simple foods based on their low likelihood to trigger EoE.
The allergy-testing elimination diet uses a combination of skin prick and atopy patch tests to detect potential EoE triggers. The empiric elimination diet, known as the six-food elimination diet (SFED), eliminates the most common food allergens, such as cow’s milk, egg, soy, wheat, peanuts and tree nuts, and fish and shellfish. The second-line option for EoE management is corticosteroid treatments such as fluticasone and budesonide. Lastly, the dilation of strictures can help to relieve dysphagia in the short term.
The EoE market is, however, evolving quickly. At present, Takeda Pharmaceutical’s Eohilia (budesonide), an oral suspension, is in the pre-registration phase and will be the first marketed drug for EoE patients in the US. In addition, the flood of pipeline agents with diverse mechanisms of action (MOAs) is expected to further expand the EoE treatment options in the US. Figure 1 summarises recent and upcoming EoE trials across all stages of development.
Sanofi and Regeneron are reportedly planning a regulatory filing for Dupixent (dupilumab), their blockbuster anti-inflammatory drug, after clearing the second Phase III trial. An interleukin 4 receptor subunit alpha inhibitor, Dupixent has been granted breakthrough therapy designation from the FDA due to a positive readout from the first Phase III trial in EoE. The drug also met its co-primary endpoints and showed significant improvements in clinical and histologic disease measures. As a result, GlobalData expects Dupixent to gain FDA approval next year.
Other pipeline drugs with different MOAs in late-stage development include Ellodi Pharmaceuticals’ glucocorticoid receptor agonist APT-1011 (fluticasone propionate), Bristol-Myers Squibb and Celgene‘s interleukin 13 inhibitor cendakimab, AstraZeneca‘s interleukin 5 receptor subunit alpha inhibitor Fasenra (benralizumab), and Allakos’ mast cell stabiliser lirentelimab. GlobalData therefore anticipates a dynamic market with a variety of treatment options for EoE patients in the near future.