Dr. James Helliwell reports
EUPRAXIA PHARMACEUTICALS REACHES ITS ENROLLMENT TARGET FOR THE Resolve TRIAL INVESTIGATING EP-104GI FOR THE TREATMENT OF EOSINOPHILIC ESOPHAGITIS
Eupraxia Pharmaceuticals Inc.'s continuing Resolve study evaluating the safety and efficacy of EP-104GI for the treatment of Eosinophilic Esophagitis (EoE) has reached its enrolment target.
"This is a significant milestone for the Resolve trial and the development of EP-104GI as a potential treatment option in EoE," said Dr. James Helliwell, chief executive officer of Eupraxia. "We look forward to our interim analysis in December where we will be reporting on symptoms, histologic findings and safety in the first 60 patients in phase 2b to reach six months. Data will also be available on the patients at three-, nine- and 12-month time points, giving a fulsome interim look at the Resolve trial."
"We're very encouraged by the blinded safety data that we have seen in the phase 1b/2a and phase 2b study to date," said Dr. Jeymi Tambiah, chief medical officer of Eupraxia. "The tolerability of the injection procedure, and of the drug, will be an important factor in determining how EP-104GI may be adopted by both patients and treating physicians if approved by the FDA. With over 3,000 injections completed and many patients having now been followed for 52 weeks, EP-104GI has been generally well tolerated, and there have been no treatment-related SAEs to date."
More details regarding the Resolve clinical trial and enrolment:
- The phase 2b placebo-controlled blinded portion of the Resolve trial is evaluating doses of 120 milligrams (20 times six mg) and 160 mg (20 times eight mg) of EP-104GI compared with vehicle control, in 120 patients randomized 1:1:1;
- On Oct. 12, 2026, Eupraxia enrolled and treated its 120th patient in the placebo-controlled blinded portion of the Resolve trial, reaching its enrolment target;
- Patients who have completed screening and qualification for the trial may still be dosed resulting in a final number dosed greater than 120 patients;
- A sequestered data management group within Eupraxia has been conducting periodic reviews of the data. During these reviews, they ensure that the statistical assumptions on efficacy are adequate and do not need to be revised. These reviews have indicated that the sample size as designed does not need to be adjusted to support the study's statistical objectives and that no increase in enrolment is required;
- To date, the phase 1b/2a and phase 2b portions of the Resolve trial have demonstrated that EP-104GI has been generally well tolerated and there have been no treatment-related SAEs.
About the Resolve trial
The phase 1b/2a portion of the Resolve trial is a multicentre, open-label, dose-escalation study evaluating the safety, tolerability, pharmacokinetics and efficacy of EP-104GI in adults with a history of confirmed active EoE.
The phase 2b portion of the Resolve trial, a randomized placebo-controlled study of EP-104GI, is evaluating both the 120-milligram (20 times six mg) and 160 mg (20 times eight mg) doses. The interim data from the phase 2b portion of the Resolve trial are expected in December, 2026.
About Eosinophilic Esophagitis (EoE)
EoE is an inflammatory-mediated disease in which white blood cells migrate into and become trapped in the esophagus, creating pain and difficulty with swallowing food. According to market research from Clearview Healthcare Partners, EoE affects more than 450,000 people in the United States and has been identified by the American Gastroenterological Association as rapidly increasing in both incidence and prevalence. Impacts from both symptoms and interventions frequently lead to mental health issues, compounding the disease burden of EoE for both the health care system and the individual.
About Eupraxia Pharmaceuticals Inc.
Eupraxia is a clinical-stage biotechnology company focused on the development of locally delivered, extended-release products that have the potential to address therapeutic areas with high unmet medical need. Diffusphere, a proprietary, polymer-based microsphere technology, is designed to facilitate targeted drug delivery of both existing and novel drugs. The technology is designed to support extended duration of effect and delivery of drugs in a hyperlocalized fashion, targeting only the tissues that physicians are wanting to treat.
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