Nine of 14 patients across the mid-to-high dose cohorts of Eupraxia’s RESOLVE trial remained in clinical remission 52 weeks after a single administration of EP-104GI, a result that matters because the drug is a corticosteroid injected directly into the esophageal wall during endoscopy, not a daily oral or biologic therapy. That 64% remission rate, sustained at one year from one procedure, is the number this program is built around.
In the highest dose group tested, Cohort 9 (20 injections of 8 mg each), two of three patients held remission at 52 weeks. The small cohort size limits how much weight that specific figure carries, but the broader pattern across cohorts 5 through 9 is consistent enough to move the program. Eupraxia’s Diffusphere technology encapsulates a drug crystal in a polymer shell, releasing the corticosteroid locally over time and, in theory, keeping systemic steroid exposure low. The tolerability data reported so far appear to support that design intent, though the Phase 1b/2a scale means the safety picture will sharpen considerably in a larger trial.
The clinical backdrop here is real. Eosinophilic esophagitis affects an estimated 472,000 patients in the United States, and the condition is typically managed with dietary elimination, proton pump inhibitors, or topical steroids that must be taken regularly. Dupilumab received FDA approval for EoE in May 2022, and budesonide formulations have followed, so approved options exist. What EP-104GI is testing is a different model: one endoscopic procedure sustaining remission for a year, rather than ongoing therapy. Whether patients and gastroenterologists find that trade-off compelling depends on how the Phase 2 data look at scale.
The 36-week data from additional cohorts were also released alongside the 52-week numbers, giving Eupraxia a fuller dose-response picture as it selects the regimen to carry forward. The number to track from here is what remission rate the company can reproduce in a placebo-controlled expansion, where the single-administration thesis either holds or doesn’t.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
