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Eupraxia Pharmaceuticals Reaches Enrollment Target for EP-104GI Study

Eupraxia Pharmaceuticals announced that the ongoing RESOLVE study evaluating the safety and efficacy of EP-104GI for the treatment of Eosinophilic Esophagitis, or EoE, has reached its enrollment target.

Eupraxia Pharmaceuticals Updates EP-104GI Clinical Data

Eupraxia Pharmaceuticals announced updated clinical data from the Phase 1b/2a RESOLVE study highlighting the long duration of response, high remission rates and tolerability of EP-104GI for the treatment of Eosinophilic Esophagitis. Key highlights: The highest dose group of EP-104GI demonstrated durability of symptom responses out to 52 weeks, with 66% of patients maintaining clinical remission; The second highest dose group of EP-104GI continued to show meaningful histologic reduction in inflammation and fibrosis with Stage -0.26 and Grade -0.27 in EoEHSS at 36 weeks; The Cohort 8b and Cohort 9 responses are consistent with clinical and histologic responses seen across all cohorts analyzed to date. "The 52-week and 36-week data from the highest dosing cohorts of the Phase 1b/2a RESOLVE trial further strengthen the observed durable treatment effects of EP-104GI in EoE patients," said Dr. James Helliwell, Chief Executive Officer of Eupraxia. "In total, we have observed 64% of patients remaining in clinical remission over this 52-week period in addition to clinically meaningful histologic improvements."

Eupraxia Pharmaceuticals Announces New Analysis Results from RESOLVE Study

Eupraxia Pharmaceuticals announced results from a new analysis of the RESOLVE study examining the effect of EP-104GI on symptom severity, including for the first time an analysis of the effect of EP-104GI on odynophagia. This is important because odynophagia scoring is a component of Dysphagia Symptom Questionnaire, a commonly used patient reported outcome used in pivotal clinical trials in EoE patients. Patients in the RESOLVE trial were asked to grade the degree of odynophagia on an 11-point scale over the seven previous days. Measurements were recorded at baseline and at weeks 2, 4, 8, 12, 24, 36 and 52 following dosing with EP-104GI. Symptom severity was graded as most severe, severe, moderate, mild or none. An analysis of the distribution of severity of symptom score was performed for the patients that received 20 injections of EP-104GI. The results are presented in the figure below. At baseline 62% of the EoE patients reported either moderate or severe odynophagia. At 2, 4, 8 and 12 weeks post treatment, 31% of patients reported moderate or severe odynophagia. At 24, 36 and 52 weeks, 25% of patients reported moderate or severe odynophagia. At baseline, 15% of patients recorded no odynophagia, at 52 weeks, 50% of patients recorded no odynophagia. Patients in the RESOLVE trial were asked to grade the degree of dysphagia on an 11-point scale over the seven previous days. Measurements were recorded at baseline and at weeks 2, 4, 8, 12, 24, 36 and 52 following dosing with EP-104GI. Symptom severity was graded as most severe, severe, moderate, mild or none. An analysis of the distribution of severity of symptom score was performed for the patients that received 20 injections of EP-104GI.