Eupraxia hits enrollment target in Phase 2b RESOLVE trial for EP-104GI
Eupraxia Pharmaceuticals enrolled and treated its 120th patient in the placebo-controlled portion of the RESOLVE trial for eosinophilic esophagitis, with interim data due in December 2026.
Eupraxia Pharmaceuticals Inc. said on October 15, 2026 that it reached its enrollment target in the Phase 2b placebo-controlled blinded portion of its RESOLVE trial testing EP-104GI in eosinophilic esophagitis. On October 12, 2026, Eupraxia enrolled and treated its 120th patient in the placebo-controlled blinded portion of the RESOLVE trial, reaching its enrollment target.1 Patients who have completed screening and qualification may still be dosed, which could push the final number dosed above 120.1
The Phase 2b portion is evaluating doses of 120mg (20x6mg) and 160mg (20x8mg) of EP-104GI compared to vehicle control, in 120 patients randomized 1:1:1.1 A sequestered internal data management group has been periodically reviewing the data to confirm that the statistical assumptions on efficacy remain adequate, and these reviews have indicated the sample size does not need to be adjusted and no additional enrollment is required.1
On safety, the Phase 1b/2a and Phase 2b portions of RESOLVE have shown EP-104GI to be generally well-tolerated with no treatment-related serious adverse events to date.1 Across both trial portions, more than 3,000 injections of EP-104GI or vehicle have been given without treatment-related SAEs.1
Interim data from the Phase 2b portion are expected in December 2026.1 According to CEO James Helliwell, the company looks forward to the interim analysis in December, which will report on symptoms, histologic findings and safety in the first 60 patients in Phase 2b to reach 6 months, along with data at 3, 9 and 12-month timepoints.1
EoE is an inflammatory disease involving white blood cell infiltration into the esophagus that causes pain and swallowing difficulty, and affects more than 450,000 people in the United States according to market research cited by the company.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.