VICTORIA, British Columbia — 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 12-week and 36-week tissue health data from its ongoing Phase 1b/2a part of the RESOLVE trial evaluating EP-104GI for the treatment of eosinophilic esophagitis (“EoE”).
“These tissue health data provide compelling evidence supporting our belief that EP-104GI is addressing the underlying pathology of EoE at the tissue level, as well as managing symptoms,” said Dr. James A. Helliwell, Chief Executive Officer of Eupraxia. “While early, the EoEHSS improvements we’re seeing are encouraging – particularly at the highest dose where patients are achieving near-complete normalization of tissue health. What’s especially encouraging is 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 New Findings from the RESOLVE Trial
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 remission2
- At 24 weeks (n=14), 79% of patients maintained clinical remission2
- At 52 weeks (n=6), 67% of patients maintained clinical remission2
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 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, 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.
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.
Notes
- As measured by EoEHSS
- Clinical remission is defined as a reduction of at least 3 points on the SDI scale. Achieving clinical remission is a positive outcome for the RESOLVE trial.
- SDI is a patient-reported outcome score that uses a seven-day recall measuring dysphagia (trouble swallowing) severity and frequency. A reduction in SDI is a positive outcome for the RESOLVE trial.
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. The technology is designed to support extended duration of effect and delivery of drugs in a hyper-localized fashion, targeting only the tissues that physicians are wanting to treat. We believe the potential for fewer adverse events may be achieved through the precision targeting and the stable and flat delivery of the active ingredient when using the Diffusphere™ technology, versus the peaks and troughs seen with more traditional drug delivery methods. The precision of Eupraxia’s Diffusphere™ technology platform has the potential to augment and transform existing FDA-approved drugs to improve their safety, tolerability, efficacy and duration of effect. The potential uses in therapeutic areas may go beyond pain and inflammatory gastrointestinal disease, where Eupraxia currently is developing advanced treatments, to also be applicable in oncology, infectious disease and other critical disease areas.
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. In addition, Eupraxia is developing a pipeline of later and earlier-stage long-acting formulations. Potential pipeline indications include candidates for other inflammatory joint indications and oncology, each designed to improve on the activity and tolerability of currently approved drugs. For further details about Eupraxia, please visit the Company’s website at: www.eupraxiapharma.com.
For investor and media inquiries, please contact:
James Meikle, Eupraxia Pharmaceuticals Inc.
236-330-7084
[email protected]
or
Kevin Gardner, on behalf of:
Eupraxia Pharmaceuticals Inc.
617-283-2856
[email protected]