Eupraxia receives positive tissue data from Resolve

Executive Summary

• Eupraxia Pharmaceuticals reported positive tissue health and clinical remission data from the ongoing phase 1b/2a Resolve trial for its drug candidate EP-104GI, intended for the treatment of eosinophilic esophagitis (EoE).
• The data demonstrates near-complete normalization of tissue health at the highest dose level (8 mg/site) at 12 weeks, with improvements maintained at 36 weeks.
• Clinical remission rates were significant, with 58% of patients achieving remission at 12 weeks and 67% maintaining remission at 52 weeks, accompanied by a favorable safety profile with no serious adverse events reported.

Key Details

• Tissue Health Outcomes (12 Weeks): Patients receiving the highest dose of EP-104GI (8 mg per site, 20 sites, n=3) showed the greatest improvement from baseline:
  • EoEHSS grade: -0.57 (94% improvement).
  • EoEHSS stage: -0.63 (97% improvement), representing near-complete normalization of tissue health.
• Tissue Health Outcomes (36 Weeks): Patients in the 4 mg per site dose groups (cohorts 5-7, n=9) maintained tissue health improvements seen at week 12:
  • EoEHSS grade: -0.22.
  • EoEHSS stage: -0.24.
• Dose-Response: A dose-response relationship in EoEHSS grade and stage was observed across cohorts ranging from 2.5 mg to 8 mg per site.
• Clinical Remission and Symptom Response: In patients treated with at least 60% of their esophagus (minimum 12 of 20 injection sites):
  • At 12 weeks (n=19): 58% achieved clinical remission.
  • At 24 weeks (n=14): 79% maintained clinical remission.
  • At 52 weeks (n=6): 67% maintained clinical remission.
• Safety and Tolerability:
  • Over 200 patient-months of follow-up reported across 31 patients.
  • No serious adverse events reported.
  • No cases of oral candidiasis.
  • Well tolerated at all dose levels, including the highest dose (8 mg per site).
• Trial Status:
  • Phase 1b/2a part is a multicentre, open-label, dose escalation study.
  • Phase 2b part is a randomized placebo-controlled study currently recruiting, with the first clinical dose of 120 mg (20 times 6 mg).
  • Top-line data from the phase 2b part are expected in the third quarter of 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," said Dr. James A. Helliwell, chief executive officer of Eupraxia.
• "What's especially encouraging is the improvement in tissue health is being accompanied by improvements in symptom relief. These improvements are maintained out to 52 weeks after a single administration with no serious adverse events, reinforcing EP-104GI's potential to significantly improve upon the current standard of care as a once-yearly treatment."