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6-K2026-04-21· glm-5

EPRX · Eupraxia Pharmaceuticals Inc.

0001171843-26-002597

SEC filing

Summary

Eupraxia Pharmaceuticals announced positive 36-week data from the highest dose cohort in its Phase 1b/2a RESOLVE trial for EP-104GI, showing robust tissue health and symptom response with no drug-related serious adverse events.

Key takeaways

Full analysis

Eupraxia Pharmaceuticals reported compelling 36-week results from the highest dose cohort (Cohort 9) of its Phase 1b/2a RESOLVE trial for EP-104GI in eosinophilic esophagitis (EoE). The data demonstrated robust and sustained efficacy, with EoEHSS Stage and Grade reductions of 90% and 88%, respectively, alongside a 72% reduction in Peak Eosinophil Count (PEC). These tissue health improvements were the highest observed across all dose cohorts in the trial. Clinical remission, defined as a 3-point reduction on the Straumann Dysphagia Index (SDI), was maintained in 66% of patients from week 8 through week 36, suggesting durability of response following a single administration.

The safety profile remains a key differentiator for EP-104GI, which utilizes the Company's proprietary Diffusphere™ technology for localized, extended-release drug delivery. Across 31 treated patients and over 230 patient-months of follow-up, no drug-related Serious Adverse Events (SAEs) were reported. Notably, there were no cases of oropharyngeal candidiasis, a common adverse event associated with swallowed steroids, and no indications of adrenal insufficiency or glucose derangement. This safety profile supports the potential advantage of localized delivery over systemic steroid administration.

The Company is advancing into the Phase 2b randomized, placebo-controlled portion of the RESOLVE trial, evaluating both 120mg and 160mg doses. Top-line data from this pivotal segment is anticipated in Q4 2026. The positive open-label data from Cohort 9 provides a strong foundation for the Phase 2b study, de-risking the program and validating the mechanism of action for this novel, locally delivered therapeutic approach in a disease with significant unmet medical need.