Eupraxia Pharmaceuticals has disclosed additional positive data from its Phase Ib/IIa RESOLVE clinical trial of EP-104GI in treating eosinophilic esophagitis (EoE).
The multicentre, open-label, dose-escalation study evaluated the safety and efficacy of the asset in adults with active, histologically confirmed EoE.
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EP-104GI is administered via injections into the oesophageal wall, with dose escalations increasing the dose per site and/or number of sites.
The trial includes multiple cohorts, with the first four cohorts undergoing assessment for up to 24 weeks, and subsequent cohorts for 52 weeks.
The latest results from the fourth cohort, utilising Eupraxia’s DiffuSphere technology, involved 12 injections of EP-104GI 2.5mg into the lower oesophagus.
Trial data indicated significant improvements in patient-reported outcomes and histological scores.
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By GlobalDataIn the trial, the Straumann Dysphagia Index (SDI), a measure of symptom severity, showed a peak decline of up to four points, equating to a 67% decrease from baseline.
At 12 weeks post-administration, the average SDI reduction was 45% or 3.3 points.
The Eosinophilic Esophagitis Histology Scoring System (EoEHSS) scores, evaluating the EoE severity and extent, exhibited a mean 39% decline in Composite Stage and a 37% decline in Composite Grade at 12 weeks. These levels were said to be comparable to those of currently approved therapies.
The trial also reported a mean reduction in Peak Eosinophil Counts (PEC) of 67% at 12 weeks, aligning with US Food and Drug Administration guidance for developing EoE treatments.
Eupraxia CEO Dr James Helliwell said: “The RESOLVE trial is progressing rapidly and we continue to observe positive data on efficacy and safety outcomes with EP-104GI, with the fifth cohort expected to read out in November 2024.
“Overall, we are encouraged by the data that we have seen across a number of key metrics and remain optimistic that we’ll see further improvements in patient response as the trial progresses towards an optimal dosing level.”
In May this year, Eupraxia received approval from regulators in Australia and Canada to expand the Phase I/II RESOLVE trial of EP-104GI for the EoE treatment.
