Eupraxia Pharmaceuticals Reports Positive Results from RESOLVE Trial of EP-104GI for Eosinophilic Esophagitis

Eupraxia Pharmaceuticals Inc., a clinical-stage biotechnology company, has recently announced promising results from its Phase 1b/2a RESOLVE trial, which is investigating EP-104GI as a potential treatment for eosinophilic esophagitis (EoE). Utilizing its proprietary DiffuSphere™ technology, Eupraxia is focused on optimizing drug delivery to address significant unmet medical needs. The latest data underscore the drug's safety and efficacy, showing sustained improvements in clinical outcomes.

In the first and second cohorts of the RESOLVE trial, patients received lower doses of EP-104GI, with each dose consisting of four to eight 1 mg injections administered to the lower esophagus. The findings from these cohorts indicate a favorable safety profile, with only mild to moderate adverse events observed, none of which were likely related to the drug. Importantly, these cohorts exhibited potential efficacy, as improvements in symptoms like dysphagia and odynophagia were maintained up to 24 weeks. Additionally, reductions in peak eosinophil counts (PEC) and Eosinophilic Esophagitis Histology Scoring System (EoEHSS) scores, which measure the severity and extent of the disease, were noted at 12 weeks in the second cohort. The results also suggest that it might be possible to extend the intervals between intra-esophageal injections with higher doses, potentially improving patient convenience and compliance.

The third cohort of the trial involved a higher dose, administering eight 2.5 mg injections, which is five times greater than the first cohort. The data from this cohort are equally encouraging, showing improvements in patient-reported symptoms and histological outcomes at 12 weeks. All three patients in this cohort reported better symptom outcomes, and reductions in PEC and EoEHSS scores were observed in two of the evaluable patients. The third patient was found not to have esophagitis after trial enrollment.

Eupraxia's RESOLVE trial is a multicentre, open-label, dose-escalation study designed to assess the safety, tolerability, pharmacokinetics, and efficacy of EP-104GI in adults with histologically confirmed active EoE. The drug is administered through a series of four to sixteen injections into the esophageal wall, with dose escalations increasing the dose per site and/or the number of sites. Participants across all cohorts will be monitored for up to 24 weeks to gather comprehensive safety and efficacy data.

Eosinophilic esophagitis is a chronic, immune-mediated disease characterized by the infiltration of white blood cells into the esophagus, causing pain and difficulty swallowing. According to research, EoE affects over 450,000 people in the United States alone and is increasing in both incidence and prevalence. The condition often leads to complications that impact mental health, exacerbating the disease burden for both patients and healthcare systems.

Eupraxia Pharmaceuticals is committed to developing localized, extended-release therapies to address high unmet medical needs. The company's technology aims to deliver targeted, long-lasting treatments with reduced side effects. The DiffuSphere™ technology, a polymer-based micro-sphere system, is designed to facilitate targeted drug delivery and can be adapted for various active pharmaceutical ingredients and delivery methods.

Previously, Eupraxia completed a Phase 2b clinical trial for another drug, EP-104IAR, aimed at treating osteoarthritis pain in the knee. This trial met its primary endpoint and three of the four secondary endpoints, further validating the potential of Eupraxia's technology. In addition to gastrointestinal diseases, Eupraxia is exploring other therapeutic areas, including inflammatory joint conditions and oncology, to develop a pipeline of long-acting formulations.

Eupraxia plans to continue disclosing additional data from the RESOLVE trial periodically, aiming to expand its clinical research and bring new therapies to market.