Core Insights - Eupraxia Pharmaceuticals has initiated the Phase 2b randomized, placebo-controlled portion of the RESOLVE clinical trial for EP-104GI, targeting eosinophilic esophagitis (EoE) [1][4] - The trial aims to enroll at least 60 participants and will assess the efficacy of EP-104GI in improving tissue health and symptomatic relief [2][5] - The study employs an adaptive design for dose selection, with the first active dose being 120 mg based on previous cohorts' data [3][5] Company Overview - Eupraxia Pharmaceuticals is a clinical-stage biotechnology company focused on developing locally delivered, extended-release products for high unmet medical needs [10] - The company's proprietary DiffuSphere™ technology aims to optimize drug delivery, potentially reducing adverse events compared to traditional methods [10] - EP-104GI is administered via esophageal wall injections, representing a novel approach for treating EoE [11] Clinical Trial Details - The Phase 2b RESOLVE trial will evaluate two active doses of EP-104GI against a placebo over a 12-month period, with primary and secondary objectives including tissue health and symptom improvement [2][5][8] - Topline data from the Phase 2b study is expected by Q3 2026, with ongoing data reporting from the Phase 2a open-label study [7][5] - The trial will involve up to 25 sites globally, assessing various clinical outcomes at multiple time points [2][5] Eosinophilic Esophagitis (EoE) Context - EoE is an inflammatory condition affecting over 450,000 individuals in the U.S., characterized by difficulty swallowing and associated mental health issues [9] - The disease has been noted for its increasing incidence and prevalence, highlighting the need for effective treatments [9]
Eupraxia Doses First Patient in Phase 2b Placebo-Controlled Portion of EP-104GI RESOLVE Trial in Eosinophilic Esophagitis