Eupraxia Expands RESOLVE Phase 1b/2a Trial for Eosinophilic Esophagitis Treatment

Eupraxia Pharmaceuticals Inc., based in Victoria, BC, recently announced regulatory approval from Australia and Canada to expand its Phase 1b/2a RESOLVE trial. This clinical trial is focused on evaluating the safety and efficacy of EP-104GI as a treatment for eosinophilic esophagitis (EoE). EoE is an inflammatory condition where white blood cells infiltrate the esophagus, causing pain and difficulty swallowing. It affects over 450,000 people in the United States and is on the rise, according to the American Gastroenterological Association.

The expansion of the RESOLVE trial comes as a result of promising data from initial low-dose cohorts, showing meaningful improvements in patient symptoms and biological markers of disease. Encouraging safety data and the duration of impact of EP-104GI support this trial expansion, paving the way for a potential registration trial in 2025.

The RESOLVE trial is designed to leverage Eupraxia’s proprietary DiffuSphere™ technology to optimize drug delivery. This technology allows for targeted, extended-release formulations that can provide longer-lasting therapeutic benefits with fewer side effects. Chief Executive Officer Dr. James Helliwell expressed optimism about the trial’s progress, noting that the encouraging data from the lowest-dose cohorts opens the door to potentially developing an effective annual therapy for EoE patients.

The protocol amendment approved by regulators includes increasing the dosage levels and extending the follow-up period for participants. The trial will now include 4 mg and 6 mg per injection site doses, with the possibility of up to 20 injection sites for dose escalation. The number of participants will also increase from the original 12-15 to 27-33, reflecting the higher dose levels being explored. An additional 10-24 participants will be enrolled in dose confirmation cohorts to thoroughly evaluate the safety and efficacy of EP-104GI at the identified doses.

To assess the potentially longer duration of effect at higher doses, the follow-up period for participants receiving more than 40 mg of EP-104GI will extend from 24 weeks to 52 weeks. An esophagogastroduodenoscopy procedure, including esophageal biopsies, will be carried out at week 36 for these participants to further evaluate the duration of the treatment’s impact.

Additional clinical sites will be added in the existing jurisdictions to support the increased recruitment target. Site feasibility assessments have also commenced to potentially open new geographic regions as needed to facilitate the trial expansion.

The data from the initial cohorts of the RESOLVE trial have shown promising results. Patients have experienced clinically meaningful symptom relief as measured by the Strauman Dysphagia Index (SDI) for as long as they have been followed, which is up to 24 weeks for the first two cohorts. Biological responses, as evidenced by Peak Eosinophil Scores (PEC) and Eosinophilic Esophagitis Histology Scores (EoEHSS), have also improved through the dose escalation process.

Eupraxia Pharmaceuticals is a clinical-stage biotechnology company dedicated to developing locally delivered, extended-release products aimed at addressing therapeutic areas with significant unmet needs. The company’s DiffuSphere™ technology is designed to facilitate targeted, long-lasting drug delivery with customizable pharmacokinetic profiles. This technology can be adapted for multiple active pharmaceutical ingredients and delivery methods.

Eupraxia recently concluded a Phase 2b clinical trial, SPRINGBOARD, for EP-104IAR, targeting pain due to knee osteoarthritis. This trial met its primary endpoint and three out of four secondary endpoints. The company has expanded the EP-104 platform into gastrointestinal diseases with the Phase 1b/2a RESOLVE trial for EoE. Additionally, Eupraxia is developing a pipeline of both later- and earlier-stage long-acting formulations, including potential candidates for other inflammatory conditions and oncology.

This expansion of the RESOLVE trial marks a significant step forward in the development of a potentially transformative treatment for EoE, offering hope for improved patient outcomes and quality of life.