Eupraxia posts 24-week data in high-dose Resolve cohort

Executive Summary

• Eupraxia Pharmaceuticals reported positive six-month (24-week) symptom data from the highest dose cohort of its ongoing Phase 1b/2a Resolve trial for EP-104GI, a treatment for eosinophilic esophagitis (EoE).
• Patients in the highest-dose cohort (20 by 8 mg) achieved an average reduction of 4.0 points in symptom scores (SDI), exceeding the 3.0-point threshold for clinical remission.
• The drug demonstrated a strong safety profile with no serious adverse events (SAEs) or cases of oropharyngeal candidiasis across 31 patients and over 220 patient-months of follow-up.

Key Details

• Symptom Response (Highest Dose Cohort):
  • Cohort 9 (20 injections of 8 mg/site; n=3) showed a mean reduction of 4.0 points in Straumann Dysphagia Index (SDI) scores at 24 weeks.
  • A reduction of 3.0 points is defined as clinical remission.
• Pooled Subanalysis (Cohorts 4-9, n≥12 injections):
  • 12 Weeks: 59% (13/22) of patients achieved clinical remission.
  • 24 Weeks: 76% (13/17) of patients maintained clinical remission.
  • 52 Weeks: 67% (6/9) of patients maintained clinical remission.
• New Cohort 8b Findings (6 mg/site):
  • Introduction of larger 19-gauge catheters resolved clogging issues seen at 6 mg/site, allowing for improved drug delivery.
  • Histologic/Symptom Improvements vs. Cohort 8:
    • EoEHSS stage/grade reductions: -0.38/-0.38 (Cohort 8b) vs. -0.08/-0.12 (Cohort 8).
    • SDI reduction: -3.8 (Cohort 8b) vs. -0.3 (Cohort 8).
    • Peak eosinophil reduction: 65.2% (Cohort 8b) vs. 30.6% (Cohort 8).
  • Cohort 8b re-established the dose-response relationship in EoEHSS.
• Safety and Tolerability:
  • 31 patients treated in Phase 1b/2a; over 220 patient-months of follow-up.
  • Zero Serious Adverse Events (SAEs) reported.
  • Zero cases of oropharyngeal candidiasis (a common side effect of swallowed steroids).
  • No cases of adrenal insufficiency or glucose derangement, including in one diabetic patient.
  • One patient in Cohort 8 was lost to follow-up at six months.
• Trial Status:
  • Phase 1b/2a is a multicentre, open-label, dose-escalation study.
  • Phase 2b is a randomized, placebo-controlled study currently recruiting for 120 mg (20 by 6 mg) and 160 mg (20 by 8 mg) doses.
  • Top-line data from the Phase 2b portion is expected in Q3 2026.

Notable Quotes

• "We are very pleased to see such a meaningful symptom response at 24 weeks in the highest dose of the phase 1b/2a portion of the Resolve study... We believe this type of response based on a single administration procedure would represent a compellingly different option for EoE patients." — Dr. James A. Helliwell, CEO
• "Importantly, the response that we are observing across cohorts 4 to 9 has increased as patients progress through the study through to week 24. We believe this demonstrates the importance of stable, continuous long-term local steroids in tamping down signs of inflammation quickly and acting on fibrosis in the longer term." — Dr. James A. Helliwell, CEO