Eupraxia Pharmaceuticals Reports Positive Tissue Health Data from its Ongoing RESOLVE Trial in Eosinophilic Esophagitis Demonstrating Near-Complete Improvement on Biopsy

Executive Summary

• Eupraxia reported positive 12‑week and 36‑week tissue‑health data from the RESOLVE Phase 1b/2a trial of EP‑104GI in eosinophilic esophagitis (EoE).
• Highest dose cohort (8 mg/site, 20 sites, n=3) achieved near‑complete normalization of tissue health (EoEHSS Grade –0.57, Stage –0.63).
• Clinical remission was observed in a majority of patients, with 58% at week 12, 79% at week 24, and 67% at week 52 among those treated ≥60% of the esophagus.
• Safety profile remained favorable: >200 patient‑months, no serious adverse events (SAEs) and no cases of oral candidiasis reported.

Key Details

• Trial Design: Open‑label, dose‑escalation; 4–20 esophageal wall injections; doses from 2.5 mg/site to 8 mg/site.
• Cohort 9 (Highest Dose): 8 mg/site, 20 sites, n=3 → EoEHSS Grade improvement –0.57 (94%); Stage improvement –0.63 (97%).
• 4 mg/site Cohorts (5‑7): 12–20 sites, n=9 → Sustained improvements at week 36 (Grade –0.22; Stage –0.24).
• Dose‑Response: Clear trend across cohorts from 2.5 mg/site to 8 mg/site in both EoEHSS Grade and Stage.
• Clinical Remission (≥60% esophagus treated):
• Week 12 (n=19) – 58% achieved remission.
• Week 24 (n=14) – 79% maintained remission.
• Week 52 (n=6) – 67% maintained remission.
• Safety & Tolerability:

• 200 patient‑months across 31 patients; no SAEs; no oral candidiasis.

• EP‑104GI well tolerated at all dose levels, including the highest.
• Future Plans: Additional data from Phase 1b/2a to be disclosed in coming months; Phase 2b (randomized, placebo‑controlled) recruiting with first dose of 120 mg (20 × 6 mg); top‑line Phase 2b results expected Q3 2026.

Notable Quotes

“These tissue health data provide compelling evidence supporting our belief that EP‑104GI is addressing the underlying pathology of EoE at the tissue level, as well as managing symptoms,” – Dr. James A. Helliwell, CEO, Eupraxia Pharmaceuticals.

Materiality Assessment: Material – Positive (significant positive clinical data for a lead product candidate).