Eupraxia's EP-104GI faces H2 2026 test after early EoE injections showed 65% EREFS gains
The placebo-controlled Phase 2b RESOLVE readout will show whether injected fluticasone propionate can convert open-label esophageal improvements into a controlled result in eosinophilic esophagitis.
Executive Summary
- Eupraxia Pharmaceuticals is running the first placebo-controlled test of its injectable corticosteroid in eosinophilic esophagitis, after earlier open-label data showed tissue-level improvement without a comparator arm.
- A positive controlled result would be the first evidence that injecting a glucocorticoid directly into esophageal tissue can outperform placebo, a mechanism no other program in this indication is testing.
- The study's completion date has shifted twice since 2023 alongside two enrollment expansions, most recently to 117 patients and a December 2026 primary completion date, a pattern consistent with a trial that grew its randomized portion rather than one that stalled.
- EP-104GI sits in a phase-diverse but mechanistically narrow EoE pipeline, competing for attention against oral budesonide, an anti-TSLP antibody, and a potassium-competitive acid blocker, none of which share its local-injection approach or its glucocorticoid-receptor target.
The catalyst
The RESOLVE trial (NCT05608681) is a Phase 1/2 study of EP-104GI, an injectable formulation of the corticosteroid fluticasone propionate delivered directly into esophageal tissue in adults with eosinophilic esophagitis. The trial dosed its first patient in the placebo-controlled Phase 2b portion on July 8, 2025, and Eupraxia has guided to topline data from that portion in the second half of 2026. The Phase 2b design randomizes patients between EP-104GI and a vehicle control and tracks tissue health by biopsy (EoEHSS and PEC scores), symptom scores (SDI and DSQ), and safety over a twelve-month period. The trial is not registrational. NCT05608681+1A Trial to Evaluate EP-104GI in Adults With Eosinophilic Esophagitis (EoE).NCT05608681Eupraxia Pharmaceuticals Reports Second Quarter 2025 Financial Results and Provides Business UpdateAug 12, 2025
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
The prior signal
Before the controlled portion began, the open-label, dose-escalation Phase 1b/2a cohorts produced the data the controlled readout must now test against a comparator. At week 12, patients receiving 20 injections showed a mean 65% reduction, or 3.6 points, in the EoE Endoscopic Reference Score (EREFS), with near-complete improvement in the highest-dose cohorts combining four patients. Eupraxia separately reported that all three patients evaluated at nine months showed sustained or improved outcomes, with no serious adverse events. Those figures came from a small, uncontrolled cohort; the placebo-controlled Phase 2b portion is the first design that can attribute improvement to the drug rather than to natural variation or endoscopic re-measurement. EupraxiaEupraxia Pharmaceuticals Reports Second Quarter 2025 Financial Results and Provides Business UpdateAug 12, 2025
Enrollment and timeline
The trial's primary completion date has moved from September 2023 to November 2024, then to December 2025, and now to December 2026, alongside enrollment increases from 24 to 57 and then to 117 patients as the study expanded into its randomized, placebo-controlled portion. Each enrollment increase paired with a completion-date extension, the pattern of a trial scaling its design rather than one losing patients. The current 117-patient target matches the registry's most recent count with no further change, which the operational model marks as a routine, unremarkable delta against Phase 1/2 norms. NCT05608681A Trial to Evaluate EP-104GI in Adults With Eosinophilic Esophagitis (EoE).NCT05608681
The competitive frame
No other industry trial pairs the NR3C1 glucocorticoid-receptor target with eosinophilic esophagitis, making EP-104GI the only asset in clinical testing on this specific target-indication pairing. The nearest direct comparator by mechanism and modality is Dr. Falk Pharma's oral budesonide, a Phase 3 program targeting histological remission with a December 2026 completion date. The broader EoE field also includes AstraZeneca's tezepelumab (anti-TSLP, Phase 3), Phathom's vonoprazan (acid-pump inhibitor, Phase 2), and Regeneron's dupilumab, already active in the indication through a distinct IL-4 receptor mechanism. None of these programs deliver a corticosteroid by local injection, which leaves EP-104GI's delivery approach untested against any direct comparator in this setting.
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