Eupraxia Pharmaceuticals reported positive 36-week tissue health and symptom data from the highest dose cohort in its ongoing Phase 1b/2a RESOLVE trial evaluating EP-104GI for eosinophilic esophagitis treatment. In Cohort 9 (20 injection sites with 8 mg per site), patients demonstrated robust and sustained responses in both tissue health and symptom measures.
At week 36, the EoEHSS Stage and Grade reductions in Cohort 9 were 0.59 and 0.53, respectively, representing a 90% and 88% reduction from baseline. Improvements were observed across both inflammatory and architectural (structural) components of the disease score, suggesting benefits in both inflammatory and fibrotic histologic aspects. Peak Eosinophil Count showed a 72% reduction from baseline in Cohort 9 at week 36, the largest reduction observed across all dose cohorts in the trial.
Clinical remission in symptoms was maintained in 66% of Cohort 9 patients (2 of 3) at week 36, with this remission first achieved at week 8 and sustained through the 36-week follow-up period. Clinical remission was defined as a 3-point reduction on the Straumann Dysphagia Index.
The safety profile remained favorable. Across 31 patients treated in the Phase 1b/2a study with over 230 patient-months of follow-up, no drug-related serious adverse events were reported. Notably, no cases of oropharyngeal candidiasis (a commonly reported adverse event with oral steroid delivery) occurred, and no cases of adrenal insufficiency or glucose derangement were observed, including in one patient with type II diabetes. EP-104GI was generally well tolerated at all dose levels, including the highest dose. Eupraxia plans to disclose additional data in coming months and expects top-line results from the placebo-controlled Phase 2b portion in the fourth quarter of 2026.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.biospace.com/press-releases/eupraxia-pharmaceuticals-reports-positive-nine-month-tissue-health-and-symptom-data-from-the-highest-dose-cohort-in-its-ongoing-phase-1b-2a-resolve-trial-in-eosinophilic-esophagitis