(RTTNews) - Eupraxia Pharmaceuticals Inc. (EPRX), a clinical-stage biotechnology company, on Wednesday announced the first release of sub-score data from the eosinophilic esophagitis histologic scoring system (EoEHSS) used in the Phase 1b/2a part of the RESOLVE trial evaluating EP-104GI in treating eosinophilic esophagitis.
Eosinophilic esophagitis (EoE) is a chronic immune disease caused by white blood cells migrating and getting stuck in the esophagus, causing pain and obstacles to swallowing. It is estimated that over 450,000 people live with the disease in the U.S. alone.
EP-104GI is being developed by Eupraxia for the treatment of EoE, and the EoEHSS is used to evaluate tissue damage in the esophagus due to EoE. The system utilizes eight individual features, four of which evaluate inflammation (EoEHSS-i), and four others evaluate architectural and fibrotic aspects (EoEHSS-a). Measurements are taken using grade (severity of disease feature) and stage (extent of disease feature).
The Phase 1b/2a RESOLVE trial is a multi-center, open-label, dose-escalation study to determine the safety, tolerability, pharmacokinetics and efficacy of EP-104GI in treating EoE. Patients were administered the drug via 4 to 20 esophageal wall injections.
Improvements were observed in EoEHSS-i and EoEHSS-a scores by week 12 and week 36 across all cohorts. In the highest-dosed cohort, 90% of patients showed an improvement in EoEHSS-i, and 83% showed improvements in EoEHSS-a scores.
Recruitment is ongoing for the Phase 2b part of the trial, and topline results are expected by the fourth quarter of this year.
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