Core Insights - Eupraxia Pharmaceuticals Inc. announced positive clinical data from its RESOLVE Phase 1b/2a trial for EP-104GI, a treatment for eosinophilic esophagitis (EoE) [2][4] Group 1: Clinical Trial Results - In the fifth cohort of the RESOLVE trial, one patient achieved complete histological remission at 12 weeks, with a significant reduction in eosinophils [3] - All six evaluable patients in the fourth and fifth cohorts reported improved symptoms, with a 41% mean reduction in the Straumann Dysphagia Index (SDI) scores at 12 weeks [3][4] - The fourth cohort showed the largest average reduction in SDI scores to date, with a four-point reduction at 24 weeks [6] - The fifth cohort demonstrated the greatest percentage change in histology scores, with a peak reduction of 100% in Stage and Grade scores and a mean 54% reduction in Composite Stage and Grade scores [3][4] Group 2: Safety and Efficacy - No serious adverse events have been reported across all five cohorts, indicating a favorable safety profile for EP-104GI [3][4] - Plasma fluticasone levels remained predictable and well below those seen in daily fluticasone asthma treatments, with no adverse events such as candidiasis or adrenal suppression reported [4] - The trial is designed as a multicenter, open-label, dose-escalation study, assessing safety, tolerability, pharmacokinetics, and efficacy of EP-104GI [4][10] Group 3: Future Developments - Cohort 6 is fully enrolled and dosed, with 12-week data expected in Q1 2025 [3] - The company plans to periodically disclose additional data from the RESOLVE trial [5]
Eupraxia Pharmaceuticals Announces Positive Data from Fifth Cohort of RESOLVE Phase 1b/2a Trial of EP-104GI for Treatment of Eosinophilic Esophagitis