Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (NASDAQ:EPRX) (TSX:EPRX), a clinical-stage biotechnology company leveraging its proprietary Diffusphere™ technology designed to optimize local, controlled drug delivery for applications with significant unmet need, today announced the first Eosinophilic Esophagitis Endoscopic Reference Score (EREFS) data from its ongoing Phase 1b/2a part of the RESOLVE trial evaluating EP-104GI for the treatment of eosinophilic esophagitis ("EoE"). These data were also presented at the ongoing Digestive Disease Week ("DDW") conference in Chicago.

"The EREFS is an important, validated visual index of severity of EoE disease in the esophagus of patients. It measures edema, rings and strictures and other visible markers of disease often associated with symptoms. Today's data demonstrated improvement in two key outcomes with EP-104GI in the treatment of EoE: first, that a full injection protocol of 20 injections resulted in more pronounced improvement than a protocol with fewer injections and less coverage area within the esophagus; second, with the higher number of injections, a consistent response in both the inflammatory and fibrotic sub scores of EREFS was observed," said Dr. James A. Helliwell, Chief Executive Officer of Eupraxia. "This EREFS data being reported at DDW is consistent with the improvements we have seen in EoE symptoms and tissue health (EoEHSS) and suggests improvement in inflammation, fibrosis and the associated narrowing of the esophagus."

Key highlights from the DDW presentation:

The EREFS measured in the study assesses the severity of five endoscopic features (domains) of EoE: edema, rings, exudates, furrows, and strictures at their most severe location. Individuals without EoE typically have EREFS at, or near, zero. Prior studies showed that patients with active EoE tend to present an EREFS of >2. Achieving an EREFS below 2 points has been validated as a response threshold in EoE1.

EREFS assessments from endoscopic examinations were conducted on all cohorts at baseline, week-12, and for patients in Cohorts 5-9 at week 36.

  • In total, 25 of 30 (83%) of participants enrolled presented with an EREFS >2 at baseline.
  • For patients with baseline scores >2, the proportion of responders (defined as patients achieving EREFS of ≤2) at week 12 increased with the number of injections given.
  • Of the 7 patients who had EREFS of >2 at baseline and 20 injections (resulting in near full coverage of the esophagus):
    • The mean reduction in EREFS was 65% (3.6 points) from baseline at week 12 (n=7).
    • EREFS improvement was near complete in the highest-dose cohorts (8b and 9, 20x6mg and 20x8mg, combined n=4).
  • EoEHSS inflammatory and fibrosis sub scores also indicate that higher dose cohorts overall suggest potentially greater improvement in either inflammatory or fibrotic features.
  • Together, these results support the selection of an injection pattern of 20 injections for higher esophageal surface coverage.

     

A summary of the above results are posted in the Scientific Publications section of the Eupraxia Pharmaceuticals website and can be found here.

About the RESOLVE Trial

The Phase 1b/2a part of the RESOLVE trial is a multicenter, open-label, dose-escalation study evaluating the safety, tolerability, pharmacokinetics, and efficacy of EP-104GI in adults with histologically confirmed active EoE. The treatment is administered as a single dose via 4 to 20 esophageal wall injections, with dose escalations modifying either the dose per site and/or the number of sites. Participants were followed for up to 24 weeks in Cohorts 1-4 (4x1mg, 8x1mg, 8x2.5mg and 12x2.5mg) or 52 weeks in Cohorts 5-9 (12x4mg, 16x4mg, 20x4mg, 20x6mg and 20x8mg). Eupraxia plans to disclose additional data from the open-label Phase 1b/2a part of the RESOLVE trial in the coming months.

The Phase 2b part of the RESOLVE trial, a randomized placebo-controlled study of EP-104GI, is currently recruiting both the 120mg (20x6mg) and 160mg (20x8mg) doses. The top-line data from the Phase 2b part of the RESOLVE trial is expected in Q4 2026.