Data Readout

Eupraxia's EP-104GI heads toward Phase 2b EoE readout after early biopsy signal

The Q4 2026 RESOLVE data will test whether injected fluticasone propionate holds up in a placebo-controlled cohort after open-label EREFS gains at 20 injections.

By AppliedXLJuly 14, 2026Trial NCT05608681

Executive Summary

Eupraxia Pharmaceuticals is heading toward a placebo-controlled readout of its injectable steroid EP-104GI in eosinophilic esophagitis, the step that will show whether an open-label signal survives a controlled comparison.
Uncontrolled dose-escalation data reported this year found that the highest injection regimen drove a drop in endoscopic disease severity, a result the placebo-controlled cohort now must reproduce.
EP-104GI's local-injection delivery of a glucocorticoid sets it apart from the oral, biologic, and acid-suppression approaches other sponsors are running in the same disease, none of which share its route or its target-class approach to esophageal drug delivery.
The trial's completion date has slipped repeatedly since 2023 alongside enrollment growth to its current target, but enrollment sits at its planned level with no shortfall, so execution risk centers on timing discipline rather than recruitment.

The catalyst

Eupraxia has guided to a Q4 2026 window, running October 1 through December 31, 2026, for top-line data from the Phase 2b randomized dose-optimization portion of RESOLVE, a Phase 1/2 trial of EP-104GI in eosinophilic esophagitis (EoE). The trial's primary completion date on the registry is December 1, 2026, inside that guided window. EoE is a chronic immune-driven inflammation of the esophagus that can cause swallowing difficulty and narrowing; EP-104GI delivers fluticasone propionate by direct injection into esophageal tissue rather than by oral or topical steroid, aiming for sustained local exposure with less systemic absorption. NCT05608681

Probability of Success

Endpoint Met7%

Completes82%

Clinical Significance20%

Regulatory99%

What the open-label data already showed

Eupraxia reported EREFS data (a validated endoscopic severity score for edema, rings, exudates, furrows and strictures) from the trial's open-label Phase 1b/2a cohorts at Digestive Disease Week in May 2026. Among the 25 of 30 enrolled patients who presented with a baseline EREFS above 2, the seven patients who received the full 20-injection regimen showed a mean EREFS reduction of 65%, or 3.6 points, from baseline at week 12, with near-complete improvement in the two highest-dose cohorts (combined n=4). Eupraxia's CEO, Dr. James A. Helliwell, said the data "suggests improvement in inflammation, fibrosis and the associated narrowing of the esophagus". These results are descriptive, cohort-level findings from an open-label design, not the placebo-controlled comparison the Phase 2b portion is built to deliver. Eupraxia

The endpoint bar

The Phase 2b randomized dose-optimization portion, which enrolls toward the trial's total target of 117 patients, is designed with a placebo comparator arm and measures change from baseline in EoEHSS grade and stage across three esophageal regions within the injection area as its primary endpoint. That places the coming readout's bar plainly: whether the histologic and endoscopic gains seen with 20 injections in the open-label cohorts persist when weighed against a placebo control rather than against each patient's own baseline. NCT05608681

Competitive position

No other industry trial shares EP-104GI's combination of the NR3C1 glucocorticoid receptor target and eosinophilic esophagitis indication; the closest comparators by mechanism and modality, an oral budesonide tablet from Dr. Falk Pharma GmbH (NCT06596252) and an intranasal fluticasone program from Optinose in a different indication, share the glucocorticoid class and small-molecule modality but not the local-injection route. Elsewhere in EoE, sponsors are pursuing different mechanisms entirely: AstraZeneca's tezepelumab and Regeneron's dupilumab target upstream inflammatory signaling, Phathom's vonoprazan targets acid suppression, and Uniquity One's solrikitug targets TSLP, none of which compete on EP-104GI's injected-steroid approach. The field is mechanistically diverse rather than convergent on a single validated approach, and EP-104GI's local-delivery route is the axis on which its Phase 2b data will need to distinguish itself. NCT05608681

Operational read

The trial's primary completion date has moved three times since initial registration, from September 2023 to November 2024, then to December 2025, and now to December 2026, while its enrollment target grew from 24 to 57 to its current 117. The enrollment target has held flat from its most recent revision, a routine pattern the trial's own operational risk model does not flag as a change. The repeated completion-date slippage, spanning more than two years since first registration, means timing discipline, not recruitment, is the operational variable that will determine whether the guided Q4 2026 window holds. NCT05608681

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