Eupraxia Pharmaceuticals Reports Additional 52-week Follow-up Data from the RESOLVE Trial in Eosinophilic Esophagitis (EoE) Demonstrating Consistent Results after Dosing with EP-104GI

Executive Summary

• Cohort 6 (3 patients) showed durable clinical benefit at 52 weeks after a single EP‑104GI administration, with 2 of 3 patients in clinical remission.
• Combined Cohorts 5 & 6 (6 patients) had 4 patients (67%) maintaining remission at 52 weeks; overall remission across Cohorts 5‑7 was 67% at week 36 (9 patients).
• No serious adverse events or cases of oral/gastrointestinal candidiasis were reported over >200 patient‑months of follow‑up.

Key Details

• Cohort 6 dosing: 16 injections × 4 mg = 64 mg total EP‑104GI.
• Clinical remission definition: ≥3‑point reduction on the Straumann Dysphagia Index (SDI).
• Remission outcomes:
• Cohort 6 – 2/3 patients in remission at week 52; all 3 maintained symptom improvement (average SDI change = ‑3.7, ‑58%).
• Cohorts 5‑6 combined – 4/6 patients in remission at week 52.
• Cohorts 5‑7 overall – 67% of measured patients in remission at week 36 (n = 9).
• Symptom improvement: Across Cohorts 5‑7, average SDI reduction at week 36 was ‑3.0 (‑53%). Across Cohorts 4‑8, average SDI reduction at week 24 was ‑3.7 (‑69%).
• Pharmacokinetics: Plasma fluticasone levels in Cohort 6 remained constant and predictable out to 52 weeks, well below concentrations seen with daily asthma inhalers.
• Safety: No SAEs; no oral or gastrointestinal candidiasis reported across >200 patient‑months.
• Future data releases: Company will disclose additional open‑label Phase 1b/2a data in the coming months.
• Phase 2b RESOLVE trial: Randomized, placebo‑controlled study recruiting; first dose 120 mg (20 × 6 mg). Top‑line results expected Q3 2026.

Notable Quotes

“These data further highlight the strong durability and tolerability profile of EP‑104GI, reinforcing its potential to become a convenient, once‑a‑year treatment… We’re very encouraged by this outcome.” – Dr. James A. Helliwell, CEO, Eupraxia Pharmaceuticals Inc.