Eupraxia announces ‘positive’ data from highest-dose cohort in RESOLVE trial

Eupraxia Pharmaceuticals (EPRX) provided an operational update on the development of EP-104GI, including reporting data from patients in Cohort 9 of the dose escalation portion of the RESOLVE trial, the first time that patients received an 8mg dose per injection. “We believe our recent financing, combined with our latest clinical trial results, underscores both the medical and investment communities’ confidence in EP-104GI. The strong efficacy trend observed in previous cohorts – the more drug we deliver to the tissue, the better the results we observe – has continued in Cohort 9. Combined with the absence of any Serious Adverse Events or cases of candidiasis, this strongly suggests that an 8mg dose per injection is the optimal second dose to test in our Phase 2b trial”, said Dr. James A. Helliwell, Chief Executive Officer of Eupraxia. “We believe EP-104GI has the potential to significantly improve upon the current standard of care, as the clinical efficacy outcomes and improvements in tissue health reported so far are well beyond the published results for the leading currently approved therapies. With the capital raised, we are well-positioned to expand our Phase 2 study, prepare for a robust Phase 3 program, and pursue additional clinical indications, subject to discussions with FDA, all with a runway extending well into 2028”. Clinical data was reported for the first time in patients receiving an 8 mg dose per injection (Cohort 9 of the dose escalation portion of RESOLVE), the highest dose planned in this trial. Patients in Cohort 9 experienced the largest improvements in tissue health outcomes and eosinophil reduction observed to date. RESOLVE Safety Committee and members of the Eupraxia Clinical Advisory Board endorsed using the 8 mg dose per injection as the second dose for the ongoing Phase 2b portion of the RESOLVE study. Eupraxia intends to expand the EP-104GI development program, including increasing the number of patients in the Phase 2b portion of RESOLVE from 60 to at least 120 patients. Eupraxia intends to initiate a clinical trial for an additional market-expanding GI indication in the first half of 2026.