Eupraxia reports data from RESOLVE Phase 1b/2a trial

Eupraxia Pharmaceuticals (EPRX)announced additional positive clinical data from its RESOLVE Phase 1b/2a trial, which is evaluating the safety and efficacy of EP-104GI as a treatment for eosinophilic esophagitis, or EoE. The results announced from the fifth cohort of the RESOLVE trial, for treatment of EoE, are derived from 12, 4 mg injections of EP-104GI administered to the lower two-thirds of each patient’s esophagus. The data show: One patient achieved complete histological remission, defined by the presence of fewer than six eosinophils per high-powered field on esophageal biopsy. Straumann Dysphagia Index, a patient-reported outcome measure designed to assess symptom severity, was lower for all three patients post-administration with peak reductions up to 3 points. At 12 weeks post-administration, mean SDI reduction was 41% or 2.3 points. Eosinophilic Esophagitis Histology Scoring System scores, which evaluate the severity and extent of EoE, showed the largest percent reduction of any cohort to date at 12 weeks, with peak reduction of 100% in Stage and Grade scores, and a mean 54% reduction in Composite Stage and Grade scores. Using data from four biopsy sites, which is consistent with the FDA Guidance for Developing Drugs for the Treatment of EoE, the mean reduction in Peak Eosinophil Counts was 83% at 12 weeks. Plasma fluticasone levels continue to be predictable and well-below published levels of daily fluticasone asthma treatments. The RESOLVE trial is a Phase 1b/2a, multicentre, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of EP-104GI in adults with histologically confirmed active EoE. EP-104GI is administered as a single dose via four to 20 injections into a patient’s esophageal wall. Dose escalations increase the dose per site and/or number of sites. Participants in the first through the fourth cohorts have been assessed for up to 24 weeks. Patients in cohorts five and above will be assessed for 52 weeks.