Eupraxia Pharmaceuticals reported six-month symptom data from its ongoing Phase 1b/2a RESOLVE trial evaluating EP-104GI for the treatment of eosinophilic esophagitis (EoE). In the highest dose cohort (20 x 8mg, n=3), patients had an average reduction of 4.0 points in Straumann Dysphagia Index (SDI) symptom scores compared to baseline, where a reduction of 3.0 points represents clinical remission. Across all dose cohorts 4-9, the decrease in symptom response was highest at 24 weeks compared to earlier timepoints, underscoring the value of continuous steroid exposure to reduce inflammation and fibrosis. Sub-analyses of pooled SDI scores from dose cohorts with at least 12 injections (cohorts 4-9) showed that at 12 weeks, 59% (13 of 22) patients achieved clinical remission, at 24 weeks 76% (13 of 17) patients maintained clinical remission, and at 52 weeks 67% (6 of 9) patients maintained clinical remission.
Safety Profile and Technical Improvements
EP-104GI has been well tolerated with no serious adverse events reported across 31 patients and over 220 patient-months of follow-up. No cases of oropharyngeal candidiasis, a commonly reported adverse event with oral steroid delivery, have been reported. There have been no cases of adrenal insufficiency or glucose derangement. During dose escalation, 6 mg/site doses caused clogging in 21-gauge catheters due to a 50% increase in particle concentration. Adoption of larger 19-gauge catheters with five times less internal resistance resolved this issue. Comparison of histologic and symptom data from a new Cohort 8b (using 19-gauge catheters at 6 mg/site) versus Cohort 8 (using 21-gauge catheters) at 12 weeks showed meaningfully improved outcomes: Cohort 8b achieved average EoEHSS stage and grade reductions of -0.38 each compared to -0.08 and -0.12 for Cohort 8, and SDI score reductions of -3.8 compared to -0.3.
Clinical Development Progress
EoE affects more than 450,000 people in the United States and has been identified as rapidly increasing in both incidence and prevalence. EP-104GI is administered as a single procedure via 4 to 20 esophageal wall injections, offering a uniquely different approach for EoE patients. The Phase 2b part of the RESOLVE trial, a randomized placebo-controlled study, is currently recruiting both the 120mg (20 x 6mg) and 160mg (20 x 8mg) doses. Top-line data from Phase 2b is expected in Q3 2026. Eupraxia is also developing EP-104IAR for knee osteoarthritis and a pipeline of later and earlier-stage long-acting formulations for potential use in inflammatory joint indications and oncology.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://menafn.com/1110871803/Eupraxia-Pharmaceuticals-Reports-Six-Month-Symptom-Data-From-The-Highest-Dose-Cohort-In-Its-Ongoing-Phase-1B2A-RESOLVE-Trial-In-Eosinophilic-Esophagitis