Eupraxia’s ( NASDAQ: EPRX) latest biopsy readout suggests that in eosinophilic esophagitis (EOE), the tissue may be healing faster than Wall Street skepticism. The company’s long‑acting injectable, EP‑104GI, is now looking less like an experiment and more like a once‑yearly contender in a market starved for durable relief.
A Once‑Yearly Shot at a Chronic Disease
Eosinophilic esophagitis, a chronic inflammatory disease that can turn every meal into a negotiation, has historically been managed with swallowed steroids, restrictive diets, and patience. Eupraxia is attempting to upend that playbook with EP‑104GI, an extended‑release fluticasone formulation injected directly into the esophageal wall to bathe the tissue in corticosteroid over many months.
Unlike daily pills or sprays that rely on patient diligence and gravity, this approach is built on the idea that one well‑placed shot can quietly work in the background for up to a year. That proposition is increasingly resonating in a field where adherence is as much a problem as inflammation.
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.
Tissue Health: Biopsies Behaving Themselves
The newest data from the ongoing RESOLVE Phase 1b/2a study suggest the esophagus is not only calmer but starting to look almost normal under the microscope. At 12 weeks, patients in the highest‑dose cohort (8 mg per site across 20 sites) showed about a 94% improvement in EoEHSS Grade and a 97% improvement in Stage, a near‑complete normalization of tissue health that is the best response seen in the trial so far.
Lower‑dose cohorts were hardly slouches; they tended to maintain tissue health gains from week 12 out to week 36, hinting at a dose‑response curve that slopes in Eupraxia’s favor. For a disease known for stubborn histology, having biopsies suddenly act like model citizens is the sort of problem clinicians do not mind having.
Symptoms, Remission and the Long Arc of a Single Dose
The trial has also been quietly answering the question every patient asks: does the biopsy improvement actually translate into feeling better. In patients who had at least 60% of their esophagus treated, a majority reached clinical remission by week 8 and many maintained that status out to 52 weeks after a single administration.delta.
These sustained symptom gains complement earlier RESOLVE updates showing improvements in dysphagia scores and patient‑reported outcomes over the first year of follow‑up. For a once‑yearly injectable, this kind of durability begins to look less like incremental innovation and more like a reset of patient expectations.
Safety Profile: No Drama, Just Data
In a field that has seen its share of safety footnotes, EP‑104GI’s tolerability so far reads almost uneventfully. Across more than 200 patient‑months of follow‑up and 31 treated patients in all cohorts, there have been no serious adverse events and no cases of oral candidiasis, a common nuisance with topical steroids.
The drug has been reported as well tolerated even at the highest dose, an important qualifier when efficacy appears to climb with dose intensity. For regulators and investors alike, boring safety slides paired with interesting efficacy curves tend to be a welcome combination.
From Phase 1b to Phase 2b – and to Wall Street
The current open‑label Phase 1b/2a portion of RESOLVE uses a dose‑escalation design, with cohorts escalating both dose per site and number of injection sites, and follow‑up extending to 52 weeks in later cohorts. With the highest dose cohort now showing the strongest tissue and eosinophil responses, the company appears to have a clearer idea of what to bring forward.
A randomized, placebo‑controlled Phase 2b arm is already enrolling, with a planned clinical dose of 120 mg delivered as 20 injections of 6 mg each and top‑line data expected in the third quarter of 2026. If those data rhyme with today’s readout, Eupraxia’s valuation discussions may shift from “can it work” to the more pleasant debate of “how big could this be” in EoE and beyond.
The Sources
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- https://finance.yahoo.com/news/eupraxia-pharmaceuticals-reports-positive-tissue-123400384.html
- https://finance.yahoo.com/news/eupraxia-pharmaceuticals-announces-positive-data-210000493.html
- https://eupraxiapharma.com/wp-content/uploads/2025/08/2024_09_10_ISDE-2024-EoE-poster_FINAL.pdf
- https://clinicaltrials.gov/study/NCT05608681
- https://lifesciencesbc.ca/members/first-set-of-1-year-clinical-results-from-resolve-trial-in-eosinophilic-esophagitis-eoe-durable-and-sustained-symptom-tissue-responses-after-dosing-with-ep-104gi/
- https://delta.larvol.com/Products/?ProductId=b17a25ca-b1c1-4eee-a3ff-308d20bebaf7
- https://www.bctechnology.com/news/2025/5/16/Eupraxia-Pharmaceuticals-Announces-Sustained-Positive-Treatment-Outcomes-in-Patients-with-Eosinophilic-Esophagitis-(EoE).cfm
- https://www.streetinsider.com/Corporate+News/Eupraxia+reports+positive+tissue+health+data+from+EoE+trial/25823083.html
- https://checkorphan.org/news/eupraxia-reports-near-complete-biopsy-improvement-in-resolve-eosinophilic-esophagitis-trial/
- https://www.theglobeandmail.com/investing/markets/stocks/EPRX-T/pressreleases/36413383/eupraxia-pharmaceuticals-reports-positive-tissue-health-data-from-its-ongoing-resolve-trial-in-eosinophilic-esophagitis-demonstrating-near-complete-improvement-on-biopsy/
- https://finance.yahoo.com/news/eupraxia-pharmaceuticals-announces-positive-data-120000545.html
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- https://sigma.larvol.com/company.php?CompanyId=781134&tab=newstrac
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