Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (NASDAQ:EPRX) (TSX:EPRX), a clinical-stage biotechnology company leveraging its proprietary Diffusphere™ technology designed to optimize local, controlled drug delivery for applications with significant unmet need, today announced positive symptom data from patients in the two highest dose cohorts from its ongoing Phase 1b/2a part of the RESOLVE trial evaluating EP-104GI for the treatment of eosinophilic esophagitis ("EoE").

"We are very pleased to see such a meaningful symptom response at 24 weeks in the highest dose of the Phase 1b/2a portion of the RESOLVE study," said Dr. James A. Helliwell, Chief Executive Officer of Eupraxia. "We believe this type of response based on a single administration procedure would represent a compellingly different option for EoE patients. Importantly, the response that we are observing across cohorts 4-9 has increased as patients progress through the study through to week 24. We believe this demonstrates the importance of stable, continuous long-term local steroids in tamping down signs of inflammation quickly and acting on fibrosis in the longer term. Also, as previously reported, we continue to be encouraged by the safety profile that we have observed with EP-104GI. Currently, with 31 patients dosed in the Phase 1b/2a study, and over 220 months of follow up, there have been no reported serious adverse events."

Key New Findings from the RESOLVE Trial

Clinical Remission and Symptom Response

Sub-analyses of pooled, available Straumann Dysphagia Index ("SDI") scores from dose cohorts including at least 12 injections (cohorts 4-9) indicated that:

  • At 12 weeks, 59% (13/22) of patients achieved clinical remission1
  • At 24 weeks, 76% (13/17) of patients maintained clinical remission1
  • At 52 weeks, 67% (6/9) of patients maintained clinical remission1

     

Furthermore, at 24 weeks, dose cohort 9 (20x8mg; n=3) showed a mean reduction of 4.0 points in SDI score where a reduction of 3.0 points is considered clinical remission.

Addition of New 6 mg/site Cohort (Cohort 8b)

During the dose-escalation part of the study, doses of 6 mg/site were found to cause clogging in the 21-gauge catheters used in earlier cohorts. The jump from 4mg/site to 6mg/site represented a 50% increase in particle concentration which disrupted fluid flow. Larger 19-gauge catheters (with five times less internal resistance) were subsequently adopted, and the increased particle density was easily accommodated. These catheters were then used for an additional four patients at the 6 mg/site dose (forming a new cohort called Cohort 8b), for Cohort 9 (8mg/site) and are currently being used in the Phase 2b portion of the RESOLVE Trial.

Comparison of histologic and symptom data from Cohort 8b versus Cohort 8 at 12 weeks demonstrated meaningfully improved outcomes due to improved drug delivery to the tissues associated with the appropriate catheter. The following results were seen:

  • EoEHSS Stage and Grade reductions: Cohort 8b achieved average reductions of -0.38 and -0.38, respectively, compared to -0.08 and -0.12 for Cohort 8
  • SDI: Cohort 8b achieved an average reduction of -3.8, compared to -0.3 for Cohort 8
  • Peak eosinophil reduction: Cohort 8b achieved an average reduction of 65.2%, compared to 30.6% for Cohort 8
  • Cohort 8b has re-established the dose-response relationship in EoEHSS across cohorts, which had not been observed in Cohort 8

Safety and Tolerability

  • Over 220 patient-months of follow-up have been reported across 31 patients in all cohorts
  • No SAEs have been reported to date
  • No cases of oropharyngeal candidiasis, a commonly reported adverse event associated with the use of swallowed steroids, have been reported to date.
  • One patient in Cohort 8 was lost to follow-up at the six-month visit
  • No cases of adrenal insufficiency or glucose derangement, including in the single patient with diabetes
  • EP-104GI has been well tolerated at all dose levels, including the highest dose of 8 mg/site

An updated summary of the above and previously announced clinical trial results are posted in the Investor Section of the Eupraxia Pharmaceuticals website and can be found here.

About the RESOLVE Trial 

The Phase 1b/2a part of the RESOLVE trial, is a multicenter, open-label, dose-escalation study evaluating the safety, tolerability, pharmacokinetics, and efficacy of EP-104GI in adults with histologically confirmed active EoE. The treatment is administered as a single dose via 4 to 20 esophageal wall injections, with dose escalations modifying either the dose per site and/or the number of sites. Participants were followed for up to 24 weeks in Cohorts 1-4 (4x1mg, 8x1mg, 8x2.5mg and 12x2.5mg) or 52 weeks in Cohorts 5-9 (12x4mg, 16x4mg,20x4mg,20x6mg and 20x8mg). Eupraxia plans to disclose additional data from the open-label Phase 1b/2a part of the RESOLVE trial in the coming months.

The Phase 2b part of RESOLVE trial, a randomized placebo-controlled study of EP-104GI, is currently recruiting both the 120mg (20 x 6mg) and 160mg (20 x8mg) doses. The top-line data from the Phase 2b part of the RESOLVE trial is expected in Q3 2026.