Eupraxia Pharmaceuticals, a clinical-stage biotechnology company leveraging its proprietary DiffuSphere technology to optimize drug delivery for applications with significant unmet need, today announced that regulators in Australia and Canada have cleared the Company’s request to expand its Phase 1b/2a RESOLVE trial, which is evaluating the safety and efficacy of EP-104GI as a treatment for eosinophilic esophagitis (EoE).
The recently disclosed clinical data from initial low-dose cohorts showing signs of potential efficacy, as well as encouraging safety and duration of impact from EP-104GI, support the significant expansion of the RESOLVE trial as a pathway to a potential registration trial commencing in 2025.
“We are excited about the data to date from the RESOLVE trial, particularly the patient responses and the extended duration of effect,” said Dr. James Helliwell, Chief Executive Officer of Eupraxia. “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 with EoE.”
The Company intends to continue to periodically disclose additional data from the trial.
Protocol Amendment Cleared By Regulators
Based on the promising data collected from the RESOLVE trial to date, the Company has expanded the Phase 1b/2a study to continue evaluating the safety and efficacy of EP-104GI at higher doses, with a longer duration of follow-up, in more participants. A protocol amendment has already been cleared by the Australian Health Authority and Health Canada. The protocol amendment for trial expansion includes:
- The addition of 4 mg/injection site and 6 mg/injection site doses and an option of up to 20 injections for dose escalation. Based on safety, pharmacokinetic, and efficacy observations in cohorts one through three, higher dose levels could potentially demonstrate a greater benefit of treatment with a longer duration of effect.
- An increase in the number of participants planned from 12-15 to 27-33, reflecting the increase in possible dose levels to be explored.
- Enrolment of an additional 10-24 participants in one or two dose confirmation cohorts, to more thoroughly evaluate safety and efficacy of EP-104GI in EoE at the doses identified during the dose escalation stage as being likely candidates for future clinical development.
- To evaluate the potentially longer duration of effect of EP-104GI at higher doses, the study follow-up was extended from 24 weeks to 52 weeks for participants who receive doses of >40 mg (total dose) of EP-104GI.
- The addition of an esophagogastroduodenoscopy procedure with esophageal biopsies at week 36 for participants who receive doses >40 mg of EP-104GI to evaluate the potentially longer duration of effect of EP-104GI at higher doses.
Additional clinical sites will be added in current jurisdictions to support the new recruitment target, and site feasibility has commenced to open additional geographic regions as needed to support the trial expansion.
The Company’s recently disclosed data from the RESOLVE study have provided a catalyst to amend the protocol for the trial.
The results announced on May 21, 2024, from the first three cohorts of the RESOLVE trial, using Eupraxia’s Diffusphere technology for EoE, show:
- Patients are seeing a clinically meaningful symptom response for as long as they have been followed as measured by Strauman Dysphagia Index (SDI) (24 weeks for cohorts one and two).
- Through the dose escalation of the first three cohorts, the biological response as seen in Peak Eosinophil Scores (PEC) and Eosinophilic Esophagitis Histology Scores (EoEHSS) has increased.
