Eupraxia Reports Positive 36-Week Data for EP-104GI in EoE Trial, Showing Sustained Efficacy & Safety
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Summary
Eupraxia Pharmaceuticals announced positive 36-week data from the highest dose cohort of its Phase 1b/2a RESOLVE trial for EP-104GI in eosinophilic esophagitis, demonstrating robust and sustained improvements in tissue health and symptoms with a favorable safety profile.
Key Events · Product Development and Regulatory · EPRX
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Positive 36-Week Data for EP-104GI in EoE Trial
Eupraxia reported 36-week tissue health and symptom data from the highest dose cohort (Cohort 9, n=3) of its Phase 1b/2a RESOLVE trial for EP-104GI in eosinophilic esophagitis (EoE).
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Robust Tissue Health Improvements
Patients in Cohort 9 demonstrated 90% and 88% reductions in EoEHSS Stage and Grade, respectively, at 36 weeks. A 72% reduction in Peak Eosinophil Count (PEC) was also observed, representing the largest reduction across all dose cohorts.
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Sustained Symptom Remission
Clinical remission in symptoms, defined as a 3-point reduction in the Straumann Dysphagia Index (SDI), was maintained in 66% (2 of 3) of patients in Cohort 9 from week 8 through 36 weeks.
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Favorable Safety Profile
EP-104GI continues to be well tolerated across all 31 patients treated, with over 230 patient-months of follow-up. No drug-related Serious Adverse Events (SAEs), oropharyngeal candidiasis, adrenal insufficiency, or glucose derangement were reported.
Analysis · EPRX · Life Sciences
Eupraxia Pharmaceuticals announced encouraging 36-week data from the highest dose cohort of its Phase 1b/2a RESOLVE trial for EP-104GI in eosinophilic esophagitis (EoE). The sustained and robust improvements in both tissue health and patient-reported symptoms, coupled with a clean safety profile, are significant for a clinical-stage biotechnology company. The data suggests EP-104GI's potential for durable efficacy and good tolerability, which is critical for a chronic condition like EoE. Investors will now look towards the upcoming additional data from the open-label Phase 1b/2a and the top-line results from the placebo-controlled Phase 2b portion of the study, expected in Q4 2026, to further validate these findings.
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