VICTORIA, British Columbia — January 8, 2026 — Leads & Copy — Eupraxia Pharmaceuticals Inc. (NASDAQ:EPRX) (TSX:EPRX) announced positive data from its ongoing Phase 1b/2a part of the RESOLVE trial evaluating EP-104GI for the treatment of eosinophilic esophagitis (“EoE”).
The clinical-stage biotechnology company reported 12-week and 36-week tissue health data, revealing that patients at the highest dose achieved the best tissue response seen in the trial to date, with a near-complete improvement in tissue health at week 12.
At lower doses, patients maintained improvements in tissue health reported at week 12 out until week 36. Clinical remission was achieved by eight weeks and maintained through 52 weeks in the majority of patients for which more than 60% of their esophagus was treated.
EP-104GI continues to be well tolerated by patients receiving the drug; over 200 patient-months of follow-up have been reported with no Serious Adverse Events (“SAEs”), and no cases of oral candidiasis.
Dr. James A. Helliwell, Chief Executive Officer of Eupraxia, said the tissue health data provides evidence supporting the belief that EP-104GI is addressing the underlying pathology of EoE at the tissue level, as well as managing symptoms. He added that while early, the EoEHSS improvements being seen are encouraging, particularly at the highest dose where patients are achieving near-complete normalization of tissue health. He also noted that the improvement in tissue health is being accompanied by improvements in symptom relief. These improvements are maintained out to 52 weeks after a single administration with no serious adverse events, reinforcing EP-104GI’s potential to significantly improve upon the current standard of care as a once-yearly treatment.
Key findings from the RESOLVE Trial include:
Tissue Health Outcomes:
- At 12 weeks after administration, patients who received the highest dose level of EP-104GI (Cohort 9, 8mg/site, 20 sites, n=3), demonstrated the greatest improvement from baseline measured to date (EoEHSS Grade: -0.57 [94% improvement], Stage: -0.63 [97% improvement]), representing near-complete normalization of tissue health.
- At 36 weeks after administration, patients in the 4mg/site dose groups (Cohorts 5-7, 12-20 sites, n=9) maintained the tissue health improvements seen at week 12 (EoEHSS Grade: -0.22, Stage: -0.24).
- A dose-response relationship in EoEHSS Grade and Stage was observed across the EP-104GI dose cohorts ranging from 2.5mg/site to 8 mg site.
Clinical Remission and Symptom Response:
Due to the open label nature of the study, data from different number of patients can be reported at different time points (2, 4, 8, 12, 24, 36 and 52 weeks) following administration of EP-104GI. To date Eupraxia has observed that in patients who had at least 60% of their esophagus treated with EP-104GI (ie. a minimum of 12 of the 20 potential injection sites injected):
- At 12 weeks (n=19), 58% of patients achieved clinical remission.
- At 24 weeks (n=14), 79% of patients maintained clinical remission.
- At 52 weeks (n=6), 67% of patients maintained clinical remission.
Safety and Tolerability Outcomes:
- To date, over 200 patient-months of follow-up have been reported in 31 patients across all cohorts.
- There have been no Serious Adverse Events (SAEs) reported.
- There have been no cases of oral candidiasis.
- EP-104GI has been reported to be well tolerated at all dose levels, including at the highest dose (8mg/site).
An updated summary of the above and previously announced clinical trial results are posted in the Investor Section of the Eupraxia Pharmaceuticals website.
The Phase 2b part of the RESOLVE trial, a randomized placebo-controlled study of EP-104GI, is currently recruiting with the first clinical dose of 120mg (20 x 6mg). The top-line data from the Phase 2b part of the RESOLVE trial is expected in Q3 2026.
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, 8×2.5mg and 12×2.5mg) 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.
About Eosinophilic Esophagitis (EoE)
EoE is an inflammatory-mediated disease in which white blood cells migrate into and become trapped in the esophagus, creating pain and difficulty with swallowing food. According to market research from Clearview Healthcare Partners, EoE affects more than 450,000 people in the United States and has been identified by the American Gastroenterological Association as rapidly increasing in both incidence and prevalence. Impacts from both symptoms and interventions frequently lead to mental health issues, compounding the disease burden of EoE for both the healthcare system and the individual.
About Eupraxia Pharmaceuticals Inc.
Eupraxia is a clinical-stage biotechnology company focused on the development of locally delivered, extended-release products that have the potential to address therapeutic areas with high unmet medical need. Diffusphere™, a proprietary, polymer-based micro-sphere technology, is designed to facilitate targeted drug delivery of both existing and novel drugs.
Eupraxia’s EP-104GI is currently in a Phase 1b/2 trial, the RESOLVE trial, for the treatment of EoE. EP-104GI is administered as an injection into the esophageal wall, providing local delivery of drug. This is a unique treatment approach for EoE.
Eupraxia also completed a Phase 2b clinical trial (SPRINGBOARD) of EP-104IAR for the treatment of pain due to knee osteoarthritis. The trial met its primary endpoint and three of the four secondary endpoints.
James Meikle, Eupraxia Pharmaceuticals Inc. can be contacted at 236-330-7084 or jmeikle@eupraxiapharma.com
Kevin Gardner can be contacted on behalf of Eupraxia Pharmaceuticals Inc. at 617-283-2856 or kgardner@lifesciadvisors.com
Source: Eupraxia Pharmaceuticals Inc.
