0001171843-26-003051
SEC filingEupraxia Pharmaceuticals announced positive Phase 1b/2a RESOLVE trial data for EP-104GI in EoE, showing over 90% improvement in inflammation and over 83% improvement in fibrosis scores at the highest dose.
Eupraxia Pharmaceuticals reported significant clinical progress for its lead gastrointestinal asset, EP-104GI, revealing the first EoEHSS sub-score data from the ongoing Phase 1b/2a RESOLVE trial. The results are critical for investors as they demonstrate the therapy's potential to address both inflammatory and fibrotic components of Eosinophilic Esophagitis (EoE), a key differentiator in treating the disease. In the highest dose cohort (Cohort 9), the company reported improvements of greater than 90% in inflammation (EoEHSS-i) and greater than 83% in tissue architecture/fibrosis (EoEHSS-a) at both 12 and 36 weeks. These histological improvements align with previously reported symptom and endoscopic (EREFS) data, suggesting a consistent therapeutic benefit.
The trial design evaluated single-dose administrations via esophageal wall injections, with Cohorts 5-9 followed for up to 52 weeks. The durability of effect out to 36 weeks in the open-label portion supports the company's proprietary Diffusphere™ technology platform, which is designed for extended, localized drug delivery. Looking ahead, the company is actively recruiting for the randomized, placebo-controlled Phase 2b portion of the RESOLVE trial, evaluating 120mg and 160mg doses. Management guided for top-line data from this pivotal phase in Q4 2026, representing a major near-term catalyst. The presentation of these data at Digestive Disease Week validates the scientific rigor of the findings and enhances visibility within the medical community.