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Drugs in Development for Eosinophilic Esophagitis: Key Summary

Medically Reviewed By Cynthia Taylor Chavoustie, MPAS, PA-C

Eosinophilic esophagitis (EoE) is hard to treat and has low adherence among patients. Dietary restrictions, in particular, can be hard for patients to stick to over the course of this chronic disease. Finding treatments that address the underlying allergic inflammation could revolutionize EoE treatment.

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The most current EoE guidelines from the American Gastroenterological Association (AGA) and the Joint Task Force on Allergy-Immunology Practice Parameters (JTF) came out in 2020. They recommend elimination diets, proton pump inhibitors (PPIs), and swallowed topical corticosteroids. However, adherence Trusted Source PubMed Central Highly respected database from the National Institutes of Health Go to source  to these treatments is a problem and they fail to resolve inflammation in about one-third of patients.

The approval of the biologic, dupilumab (Dupixent), in 2022 marked a turning point in EoE treatment, with a targeted therapy. This article summarizes some emerging treatments that could shape the future of EoE treatment.

New formulations of swallowed topical corticosteroids

Swallowed topical corticosteroids (STCs) have been part of EoE treatment for quite some time. The challenge has been in the delivery – getting the steroid to the esophageal mucosa, while limiting systemic exposure.

This has usually been accomplished by compounding viscous dosage forms of budesonide or fluticasone or using products intended for asthma, but swallowing them instead of inhaling them. The latter approach can be a challenge for patients to do correctly, can affect adherence, and can be a hurdle with insurance coverage.

New dosage forms are clearly an unmet need in EoE treatment. The U.S. Food and Drug Administration (FDA) has previously rejected a budesonide suspension for EoE. However, the quest continues with the investigational drug APT-1011 (fluticasone propionate oral disintegrating tablet), which is currently in phase III testing. The FDA has granted it Orphan Drug and Fast Track Designations. 

Biologics

Research into biologic molecules for EoE has accelerated in the last few years. While dupilumab is the only one currently with approval, there are some in phase II and II clinical trials including:

  • barzolvolimab, which binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for the function and survival of the mast cell
  • cendakimab, which is a high affinity, anti-interleukin-13 (IL-13) monoclonal antibody

Several others have been in development, but have not cleared efficacy endpoints. While there is evidence for histologic improvement, improvements in symptoms remain elusive. This has sidelined several from gaining approval for an EoE indication, including:

  • benralizumab (Fasenra), which is approved for add-on maintenance of severe asthma with an eosinophilic phenotype
  • lirentelimab (AK002), which is an investigational monoclonal antibody that depletes eosinophils and inhibits mast cells
  • mepolizumab (Nucala), which is approved for four eosinophilic disorders
  • reslizumab (Cinqair), which is approved for add-on maintenance of severe asthma with an eosinophilic phenotype

Although not a biologic, the drug etrasimod (Velsipity) has shown promise in treating EoE.

The takeaway 

Several new treatments are on the horizon for EoE and there is an approved biologic for the disease. As new treatments come to market, it is important to consider their place in therapy. Due to the cost of biologics, insurance plans are likely to require documentation that other treatments have failed. For now, the standard EoE treatments are still first-line.

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  1. APT-1011. https://ellodipharma.com/research/
  2. Celldex announces first patient dosed in phase 2 study of barzolvolimab in eosinophilic esophagitis. https://ir.celldex.com/news-releases/news-release-details/celldex-announces-first-patient-dosed-phase-2-study-1
  3. Cendakimab by Bristol-Myers Squibb for eosinophilic esophagitis: Likelihood of approval. https://www.pharmaceutical-technology.com/data-insights/cendakimab-bristol-myers-squibb-eosinophilic-esophagitis-likelihood-of-approval/?cf-view
  4. FDA rejects application for budesonide treatment. (2022). https://www.eosnetwork.org/news/fda-rejects-application-for-budesonide-treatment
  5. Glowczewski, A., et al. (2022). Formulations of topical steroids in eosinophilic esophagitis—current treatment and emerging possibilities.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8910832/
  6. Hirano, I., et al. (2020). AGA Institute and the Joint Task Force on Allergy-Immunology Practice Parameters clinical guidelines for the management of eosinophilic esophagitis. https://www.gastrojournal.org/article/S0016-5085(20)30265-1/pdf?referrer=https%3A%2F%2Fwww.ncbi.nlm.nih.gov%2F
  7. Rosenberg, J. (2022). Success in eosinophil-targeted treatments for EoE remains limited. https://www.ajmc.com/view/success-in-eosinophil-targeted-treatments-for-eoe-remains-limited
  8. Strong, C. (2023). Etrasimod shows promising results for eosinophilic esophagitis. https://www.gastroenterologyadvisor.com/reports/etrasimod-improves-eosinophilic-esophagitis-symptom-severity-dysphagia/

Medical Reviewer: Cynthia Taylor Chavoustie, MPAS, PA-C
Last Review Date: 2023 Oct 18
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