On Monday, Eupraxia Pharmaceuticals Inc. (NASDAQ:EPRX) reported data from patients in Cohort nine of the dose escalation portion of the RESOLVE trial in Eosinophilic Esophagitis (EoE) patients, the first time patients received an 8mg dose per injection.
Select Data:
Clinical Remission: Rapid and meaningful induction of clinical remission observed as measured by the Straumann Dysphagia Index (SDI).
Tissue Health and Eosinophil Reduction: Greatest improvements to date in EoEHSS (Eosinophilic Esophagitis Histological Scoring System) scores, with the greatest percentage of biopsy sites in remission (≤6 eos/hpf).
Correlation to Outcomes: When more drug is delivered into the tissue across all cohorts, greater disease resolution and eosinophil reduction are observed.
Durability: Long-term data demonstrate that patients maintained clinical benefit, tissue health, and tolerability.
Safety Outcomes: Zero SAEs and zero cases of candidiasis reported across all patients, including those at the 8mg per injection dose
Based on the safety and efficacy results from Cohort 9 in the open-label dose escalation (Phase 1b/2a study), Eupraxia expects to select the 8 mg/per injection & 20 injections per administration (for a total of 160 mg per patient) as the second active dose level for the Phase 2b portion of the RESOLVE trial.
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Eupraxia intends to increase the size of the Phase 2b portion of the RESOLVE Trial to a minimum of 40 patients per dose group.
The total number of patients enrolled is expected to increase from 60 to at least 120.
In addition to increasing the size of the RESOLVE study, Eupraxia intends to use proceeds from the recent financing to expand the non-clinical and clinical program for EP-104GI, subject to discussions with the FDA, to increase the future market size of the program, including:
Development of additional indications for EP-104GI in the GI field; the company plans to dose the first patients in the first half of 2026.
The company is considering indications where localized treatment would provide maximum benefit, such as fibrostenotic Crohn’s, treatment of benign esophageal strictures, and the prevention of strictures in Barrett’s esophagus.
Completion of non-clinical work to enable repeat dosing and inclusion of adolescent patients in the Phase 3 program.
Development work of applications for Diffusphere with other Active Pharmaceutical Ingredients other than fluticasone propionate
Eupraxia plans to disclose additional data from the open-label Phase 1b/2a part of the RESOLVE trial in the fourth quarter of 2025.
The Phase 2b part of the RESOLVE trial of EP-104GI is currently recruiting with the first clinical dose of 120mg (20 x 6mg). The top-line data from the Phase 2b part of the trial is expected in the third quarter of 2026.
Price Action: EPRX stock is up 0.89% at $5.80 at the last check on Tuesday.
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