Eupraxia Pharmaceuticals Announces Positive Data from Highest-Dose Cohort in the Ongoing RESOLVE Trial in Eosinophilic Esophagitis, and Plans for Expansion of EP-104GI Development Programs
Executive Summary
- First presentation of data from Cohort 9 (8 mg per injection) in the RESOLVE dose‑escalation trial, showing the largest efficacy improvements to date and no serious adverse events.
- The RESOLVE Safety Committee and Clinical Advisory Board endorsed the 8 mg dose as the second active dose for the upcoming Phase 2b study; patient enrollment will be expanded from ~60 to at least 120 participants.
- Eupraxia plans additional GI‑indication trials in early‑2026 and will use proceeds from its recent financing to broaden non‑clinical and clinical work on EP‑104GI.
Key Details
- Cohort 9 Results:
- Dose: 8 mg per injection (highest planned dose).
- Clinical remission measured by Straumann Dysphagia Index (SDI) – rapid, meaningful induction.
- Greatest improvements in tissue health (EoEHSS scores) and eosinophil reduction observed to date.
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Safety: Zero serious adverse events (SAEs) and zero cases of candidiasis across all patients, including the 8 mg cohort.
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Phase 2b Trial Adjustments:
- Selected dose for second active arm: 8 mg per injection × 20 injections = 160 mg total per patient.
- Minimum enrollment per dose group increased to 40 patients; overall Phase 2b size raised from ~60 to ≥120 patients.
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Anticipated benefits: higher statistical power, larger safety database, stronger case for breakthrough designation, potential to limit development to a single pivotal Phase 3 trial, and better dose optimization for Phase 3.
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Future Development Plans:
- Expand EP‑104GI program using financing proceeds; target additional GI indications (fibrostenotic Crohn’s disease, benign esophageal strictures, prevention of Barrett’s esophagus strictures) with first patient dosing slated for H1 2026.
- Complete non‑clinical work to enable repeat dosing and inclusion of adolescent patients in Phase 3.
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Explore Diffusphere™ platform applications with other APIs beyond fluticasone propionate.
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Upcoming Communications:
- Webinar scheduled for October 1, 2025 at 8 am PDT (live link: https://lifescievents.com/event/fk30t7wg2n/).
Notable Quotes
“The strong efficacy trend observed in previous cohorts – the more drug we deliver to the tissue, the better the results we observe – has continued in Cohort 9… With the capital raised, we are well‑positioned to expand our Phase 2 study, prepare for a robust Phase 3 program, and pursue additional clinical indications…” – Dr. James A. Helliwell, CEO, Eupraxia Pharmaceuticals Inc.