EP-104GI Holds Remission to 36 Weeks in EoE Dose Escalation

Eupraxia Pharmaceuticals has released 36-week tissue health and symptom data from the highest dose cohort in its ongoing Phase 1b/2a RESOLVE trial, with results that will sharpen attention on local controlled-release steroid delivery as a formulation strategy in eosinophilic esophagitis. For QA and regulatory teams tracking the pipeline of swallowed-steroid alternatives, the sustained remission profile and absence of systemic adverse events at this dose level represent a clinically meaningful signal ahead of the placebo-controlled Phase 2b portion of the study.

In Cohort 9, which received EP-104GI at 20 injection sites of 8 mg each, patients (n=3) demonstrated EoEHSS Stage and Grade reductions of 0.59 and 0.53 at week 36, representing 90% and 88% reductions respectively from baseline. Peak Eosinophil Count fell by 72% from baseline, the largest PEC reduction recorded across all dose cohorts in the trial. Improvements were observed across both inflammatory and architectural components of the EoEHSS score, indicating activity against both inflammatory and fibrotic histologic disease features. On the symptom side, 2 of 3 patients maintained clinical remission as defined by a 3-point or greater reduction in the Straumann Dysphagia Index from week 8 through week 36, a 66% clinical remission response rate. Cohort 9 also recorded the highest tissue health response at week 36 compared to all other dose cohorts in the RESOLVE trial.

The safety dataset now spans 31 patients and more than 230 patient-months of follow-up across all cohorts. No drug-related serious adverse events have been reported. Notably, no cases of oropharyngeal candidiasis have emerged, a finding relevant to formulators and clinical operations teams given that candidiasis is a commonly reported adverse event with oral swallowed steroid delivery. No cases of adrenal insufficiency or glucose derangement were observed, including in the single enrolled patient with type II diabetes. The tolerability profile at the highest dose level, 160 mg total administered across 20 sites, will be a reference point for the dose selection rationale entering Phase 2b.

EP-104GI is built on Eupraxia's proprietary Diffusphere technology, a controlled-release platform designed to optimize local drug delivery. For process development and CMC teams at clinical-stage companies, the RESOLVE dataset illustrates both the promise and the complexity of scaling microsphere-based local delivery systems: achieving consistent particle size distribution, drug loading uniformity, and injectability across a multi-site endoscopic administration protocol introduces manufacturing variables that will require robust process validation frameworks aligned with ICH Q10 and 21 CFR Part 211 expectations before any pivotal filing. The transition from Phase 1b/2a dose escalation to a placebo-controlled Phase 2b study will test whether those controls hold at commercial-relevant batch scales.

Eupraxia announced the data on April 21, 2026. The company noted that the same dose level evaluated in Cohort 9 is being further assessed in the placebo-controlled Phase 2b portion of the RESOLVE trial. No timeline for Phase 2b data readout was specified in the release.