Eupraxia's EP-104GI Shows Sustained Clinical Remission in Eosinophilic Esophagitis Patients at 52 Weeks
Key Insights
Eupraxia Pharmaceuticals (search) reported 52-week follow-up data from its RESOLVE trial showing EP-104GI (search) maintained clinical remission in 67% of eosinophilic esophagitis (search) patients who had at least 60% of their esophagus (search) treated.
The investigational treatment demonstrated sustained tissue healing and symptom improvement, with patients in the 4 mg/site cohorts maintaining tissue health gains observed at week 12 through 36 weeks.
EP-104GI (search) showed a favorable safety profile with no serious adverse events or cases of oral candidiasis reported across over 200 patient-months of follow-up in 31 patients across all cohorts.
Eupraxia Pharmaceuticals (search) Inc. (NASDAQ:EPRX) reported sustained clinical benefits from its investigational treatment EP-104GI (search) for eosinophilic esophagitis (search) (EoE (search)), with 52-week follow-up data from the Phase 1b/2a portion of the RESOLVE trial demonstrating maintained clinical remission in two-thirds of patients.
The company announced that among patients who had at least 60% of their esophagus (search) treated with EP-104GI (search), 67% maintained clinical remission at 52 weeks, compared to 79% at 24 weeks and 58% at 12 weeks. The data represents outcomes from six patients at the 52-week timepoint.
Tissue Healing and Symptom Improvement
At 12 weeks, patients receiving the highest dose of 8 mg per injection site showed the strongest improvement from baseline, approaching near-complete normalization of esophageal tissue. Patients in the 4 mg/site cohorts sustained the tissue health gains observed at week 12 through 36 weeks.
For dysphagia (search) symptoms measured by the Straumann Dysphagia Index (SDI), patients in Cohort 6 who received 16 injections of 4 mg EP-104GI (search) (64 mg total dose) maintained symptom improvements at week 52, with an average reduction in SDI scores of -3.7, representing a 58% improvement. Two of three patients in this cohort were in clinical remission at the 52-week mark.
Across multiple cohorts, clinical remission rates varied by timepoint: 67% at week 36 (Cohorts 5-7) and 79% at week 24 (Cohorts 4-8), with corresponding average SDI score reductions of -3.0 (-53%) and -3.7 (-69%), respectively.
Safety Profile and Pharmacokinetics
EP-104GI (search) demonstrated a favorable safety profile across all dose levels tested. With over 200 patient-months of follow-up reported in 31 patients across all cohorts, no serious adverse events have been reported, and no cases of oral or gastrointestinal candidiasis have occurred.
Plasma levels of fluticasone in patients treated with the 64 mg total dose remained constant and predictable out to 52 weeks, staying well below levels typically observed with daily asthma inhalers, according to the company.
Trial Design and Future Plans
The Phase 1b/2a portion of the RESOLVE trial is a multicenter, open-label, dose-escalation study evaluating EP-104GI (search) in adults with histologically confirmed active EoE (search). The treatment is administered as a single dose via 4 to 20 esophageal wall injections, with participants in later cohorts followed for up to 52 weeks.
The Phase 2b portion of the RESOLVE trial, a randomized placebo-controlled study, is currently recruiting patients with an initial clinical dose of 120mg (20 x 6mg). Eupraxia expects to report top-line data from this phase in Q3 2026.
Disease Background and Market Impact
EoE (search) is an inflammatory-mediated disease affecting more than 450,000 people in the United States, according to market research from Clearview Healthcare Partners. The American Gastroenterological Association has identified EoE as rapidly increasing in both incidence and prevalence. The condition involves white blood cells migrating into and becoming trapped in the esophagus (search), creating pain and difficulty swallowing food.
EP-104GI (search) utilizes Eupraxia's proprietary Diffusphere technology, designed to facilitate targeted drug delivery through polymer-based micro-spheres that enable extended duration of effect and hyper-localized drug delivery to specific tissues.