Canada-based clinical-stage biotechnology company Eupraxia Pharmaceuticals Inc (TSX: EPRX) (NASDAQ: EPRX) announced on Tuesday additional positive clinical data from its RESOLVE Phase 1b/2a trial assessing the safety and efficacy of EP-104GI as a treatment for eosinophilic esophagitis (EoE).
Results from the fifth cohort of the RESOLVE trial, for treatment of EoE, are derived from 12, 4 mg injections of EP-104GI (total dose of 48 mg) administered to the lower two-thirds of each patient's oesophagus.
One patient achieved complete histological remission, defined by the presence of fewer than six eosinophils per high-powered field on oesophageal biopsy; Straumann Dysphagia Index (SDI), a patient-reported outcome measure designed to assess symptom severity, was lower for all three patients post-administration with peak reductions up to three points (50% from baseline), and at 12 weeks post-administration mean SDI reduction was 41% or 2.3 points; Eosinophilic Esophagitis Histology Scoring System (EoEHSS) scores indicated the largest percentage decrease of any cohort to date at 12 weeks, with peak decrease of 100% in Stage and Grade scores, and a mean 54% decrease in Composite Stage and Grade scores; and the mean reduction in Peak Eosinophil Counts was 83% at 12 weeks using data from four biopsy sites, which is consistent with the US Food and Drug Administration Guidance for Developing Drugs for the Treatment of EoE.
Eupraxia plans to continue reporting additional data from the trial periodically.
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Eupraxia Pharmaceuticals reveals additional data from RESOLVE Phase 1b/2a trial of EP-104GI