Core Insights - Eupraxia Pharmaceuticals announced positive clinical data from its Phase 1b/2a RESOLVE trial for EP-104GI, a treatment for eosinophilic esophagitis (EoE), showing promising results at 52 weeks post-treatment [1][2]. Clinical Trial Results - The RESOLVE trial demonstrated that patients receiving 4mg of EP-104GI showed clinical remission rates of 56% at Week 12, 78% at Week 24, 67% at Week 36, and 67% at Week 52 [3]. - Two-thirds of patients in the 48mg dose cohort maintained clinical remission after 12 months, indicating durable treatment effects [7]. - Improvements in tissue health were observed across all cohorts, with significant reductions in EoE Histological Scoring System (EoEHSS) scores, showing a 47% improvement in severity and a 44% improvement in extent at Week 36 [8]. Pharmacokinetics - Plasma levels of fluticasone in patients treated with 4mg of EP-104GI remained stable and predictable over 52 weeks, significantly lower than levels typically seen with daily asthma inhalers [9][11]. Market Potential - The treatment regimen for EP-104GI could align with the annual endoscopy routine for EoE patients, contrasting with current treatments that require daily or weekly administration [2]. - EoE affects over 450,000 individuals in the U.S., with increasing incidence and prevalence, highlighting a significant market opportunity for effective treatments [17]. Company Overview - Eupraxia Pharmaceuticals focuses on developing locally delivered, extended-release products targeting high unmet medical needs, utilizing its proprietary Diffusphere™ technology for optimized drug delivery [18][19].
First Set of 1-Year Clinical Results from RESOLVE Trial in Eosinophilic Esophagitis (EoE), Durable and Sustained Symptom & Tissue Responses after Dosing with EP-104GI