Eupraxia Pharmaceuticals has received approval from regulators in Australia and Canada to expand the Phase I/II RESOLVE clinical trial of EP-104GI, for the treatment of eosinophilic esophagitis (EoE).

The expansion follows promising initial data and aims to explore higher doses and longer follow-up periods in additional trial subjects.

The dose-escalation, multi-centre, open-label study is designed to assess the safety, pharmacokinetics, tolerability, and efficacy of EP-104GI in adult patients with active EoE.

EP-104GI is administered through injections directly into the oesophageal wall.

Initial low-dose cohorts have shown potential efficacy and safety, leading to the decision to expand the trial.

This could pave the way for a registration trial set to commence next year.

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The protocol amendment cleared by the Australian Health Authority and Health Canada includes new doses and an increase in the number of injection sites.

The participant count is set to rise from 12-15 to 27-33, with an additional 10-24 participants to be enrolled in dose confirmation cohorts.

To assess the longer-term effects of EP-104GI, the follow-up duration has been extended to 52 weeks for those receiving doses higher than 40mg.

Eupraxia plans to add more study sites within existing jurisdictions and is also assessing new regions to support the expanded trial.

Eupraxia Pharmaceuticals CEO Dr James Helliwell said: “We are excited about the data to date from the RESOLVE trial, particularly the patient responses and the extended duration of effect.

“Our DiffuSphere delivery technology is a supporting factor for this opportunity for higher dosing, which could result in a longer duration of efficacy and more profound patient improvement. We believe that the encouraging data seen in patients in our lowest-dose cohorts opens the door, with this amendment, to develop a potentially efficacious annual therapy with a strong safety profile for patients suffering from EoE.”