Eupraxia releases first set of Resolve clinical results

Executive Summary

• Eupraxia Pharmaceuticals released the first 1-year clinical data from its phase 1b/2a Resolve trial for EP-104GI, a treatment for eosinophilic esophagitis (EoE).
• The data demonstrates durable and sustained symptom and tissue responses up to 52 weeks post-dosing, supporting the potential for a once-a-year therapy.
• The company highlights the convenience of EP-104GI compared to current standards of care (daily oral steroids or weekly biologic injections) and plans to report additional 12-month data from a larger patient set later this year.

Key Details

• Trial Phase: Phase 1b/2a Resolve trial.
• Indication: Eosinophilic Esophagitis (EoE).
• Drug: EP-104GI (locally delivered, extended-release formulation using Diffusphere technology).
• Dose Group Analyzed: Four-milligram (4 mg) per injection.
• Symptom Response (Straumann Dysphagia Index):
  • Week 12: 56% clinical remission (n=9).
  • Week 24: 78% clinical remission (n=9).
  • Week 36: 67% clinical remission (n=6).
  • Week 52: 67% clinical remission (n=3).
• Tissue Health Improvements (EoEHSS):
  • Mean improvement in grade (severity): 47%.
  • Mean improvement in stage (extent): 44%.
  • Data measured at week 36 for the 4 mg group (n=6).
• Pharmacokinetics:
  • Plasma levels of fluticasone remained level and predictable out to 52 weeks.
  • Levels were well below those typically observed with daily asthma inhalers.
• Safety Profile:
  • No Serious Adverse Events (SAEs) reported to date.
  • No incidence of oral or gastrointestinal candidiasis reported.
• Future Plans: Additional 12-month data from a larger patient set expected later this year.

Notable Quotes

• "We believe the prolonged duration of symptom response that we are seeing with EP-104GI is truly a unique clinical result and will potentially provide a once-a-year therapy to patients with EoE, and, over all, we continue to see that the more drug we deliver to the tissues, the better the results," said Dr. James A. Helliwell, chief executive officer of Eupraxia.
• "Based on this, leading KOLs in EoE see a potential treatment regimen where EP-104GI is administered during this routine annual procedure, in contrast to current standards of care which are inconvenient and involve swallowing oral steroids daily or injecting themselves weekly with a biologic. As a result, we believe EP-104GI has the potential to significantly enhance the current standard of care for patients with EoE."