Eupraxia Pharmaceuticals reported that its Phase 1b/2a RESOLVE trial of EP‑104GI produced encouraging 12‑ and 36‑week tissue‑health data in patients with eosinophilic esophagitis (EoE). The highest dose cohort achieved near‑complete normalization of esophageal tissue health, and the improvement was maintained through 52 weeks after a single administration, with no serious adverse events observed.
The results underscore the potential of EP‑104GI as a once‑yearly, locally delivered therapy. The drug is delivered via the company’s proprietary Diffusphere™ platform, which releases fluticasone propionate directly into the esophageal wall through 4 to 20 injections, providing sustained local exposure while limiting systemic absorption. This delivery strategy could give EP‑104GI a distinct advantage over current EoE treatments such as dietary therapy, proton‑pump inhibitors, topical corticosteroids, and the biologic dupilumab.
Eosinophilic esophagitis affects more than 450,000 people in the United States and is a chronic, immune‑mediated disease that currently requires ongoing medication or dietary restrictions. The near‑complete tissue‑health response observed in the RESOLVE trial suggests that EP‑104GI may address the underlying pathology more effectively than existing options, potentially improving long‑term disease control and patient quality of life.
The data will inform the design of the ongoing Phase 2b, placebo‑controlled portion of the RESOLVE trial, with top‑line results expected in the third quarter of 2026. In addition, Eupraxia plans to initiate a new gastrointestinal indication trial in the first half of 2026, expanding the potential market for its Diffusphere technology.
CEO Dr. James A. Helliwell said, “These tissue‑health data provide compelling evidence that EP‑104GI is addressing the underlying pathology of EoE at the tissue level, while also delivering symptom relief. The durability of the response over 52 weeks and the absence of serious adverse events reinforce our confidence that EP‑104GI could become a once‑yearly treatment that significantly improves upon the current standard of care.”
Analysts have expressed optimism about the data, noting the potential for a differentiated once‑yearly therapy that could reshape the EoE treatment landscape.
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