Eupraxia hits 120-patient target in RESOLVE EoE trial
Eupraxia Pharmaceuticals has completed enrolment in the placebo-controlled Phase 2b portion of its RESOLVE trial, reaching its target of 120 patients on 12 October 2026. The trial is evaluating EP-104GI, a locally delivered, extended-release formulation of a corticosteroid administered by injection into the oesophageal wall, as a potential treatment for eosinophilic oesophagitis (EoE).
The NASDAQ- and TSX-listed Vancouver biotech said an interim analysis of the Phase 2b data is on track for December 2026. That readout will cover symptoms, histological findings and safety in the first 60 patients to reach six months of follow-up, with additional data available at the three, nine and 12-month timepoints.
Safety profile and trial design
EP-104GI is delivered via Eupraxia's proprietary Diffusphere microsphere platform, which the company says is designed to maintain stable local drug concentrations and minimise systemic exposure. The Phase 2b study is randomising patients 1:1:1 across two active doses, 120mg (20 injections of 6mg each) and 160mg (20 injections of 8mg each), against a vehicle control.
Across both the open-label Phase 1b/2a and the blinded Phase 2b portions of RESOLVE, more than 3,000 injections have now been administered. Chief medical officer Jeymi Tambiah said there have been no treatment-related serious adverse events to date and that EP-104GI has been "generally well-tolerated," adding that the tolerability of the injection procedure would be a material factor in potential clinical adoption.
A sequestered data management group within Eupraxia has conducted periodic unblinded reviews focused solely on statistical assumptions and sample size adequacy. Those reviews have confirmed that no increase in enrolment beyond 120 patients is required to meet the study's primary objectives, a positive procedural signal ahead of the efficacy readout.
Market context and competitive landscape
EoE is an immune-mediated inflammatory disease in which eosinophils accumulate in the oesophageal lining, causing pain and dysphagia. The condition affects an estimated 450,000 people in the United States and is described by the American Gastroenterological Association as growing in both incidence and prevalence, making it an increasingly active area for drug development.
The treatment landscape has expanded in recent years. Dupixent (dupilumab), the IL-4/IL-13 blocking antibody co-developed by Regeneron and Sanofi, received FDA approval for EoE in 2022 and is widely considered the current standard of care for patients who do not respond to proton pump inhibitors or swallowed topical corticosteroids. A locally delivered, long-acting corticosteroid such as EP-104GI would be targeting a different mechanistic approach and potentially a different patient segment, though the December interim data will be the first opportunity to assess whether the efficacy signal is competitive.
Eupraxia is also developing EP-104GI's Diffusphere platform for other inflammatory indications, and the company has previously suggested potential applicability in oncology and infectious disease, though no candidates in those areas have entered the clinic. Investors will be focused almost entirely on the December readout for now. Positive symptom and histology data from the first 60 Phase 2b patients would represent a material de-risking event and could inform decisions on partnering or follow-on financing ahead of a potential Phase 3 design discussion with the FDA.