Eupraxia Pharmaceuticals Reports Positive Results from EP-104GI Trial for Eosinophilic Esophagitis

Eupraxia Pharmaceuticals Inc., a biotechnology firm focused on precision drug delivery, has shared promising results from its RESOLVE Phase 1b/2a clinical trial. This trial is assessing the potential of EP-104GI in treating eosinophilic esophagitis (EoE), a chronic allergic condition marked by an overabundance of white blood cells in the esophagus, causing pain and swallowing difficulties.

The RESOLVE trial is an open-label, dose-escalation study involving multiple cohorts. It primarily examines the safety, tolerability, and efficacy of EP-104GI by evaluating various clinical parameters such as the Symptom Improvement (SDI), changes in tissue health as measured by the Eosinophilic Esophagitis Histology Scoring System (EoEHSS), and Peak Eosinophil Count (PEC).

Dr. James Helliwell, CEO of Eupraxia, expressed optimism about the trial outcomes, emphasizing the observed improvements in symptom relief and tissue health with increased dosages of EP-104GI. Importantly, no serious adverse events or cases of oral or gastrointestinal candidiasis—common in steroid treatments for EoE—were reported across the initial six cohorts.

Particularly noteworthy were the findings from the sixth cohort. Participants in this group received 16 injections totaling 64 mg of EP-104GI, covering the majority of the esophagus. This cohort exhibited the most significant improvement in symptom relief and tissue health metrics compared to previous cohorts. Symptom severity decreased notably, with patients reporting up to a 71% reduction in their SDI scores. The reduction in eosinophil count was also substantial, with an average 94% decrease in eosinophils in the biopsied sites.

Histological improvements were impressive as well, showing an 89% reduction in peak stage scores and an 88% reduction in grade scores. These outcomes suggest a strong dose-response effect with EP-104GI, as higher doses lead to enhanced therapeutic outcomes.

The sixth cohort's results suggest that maximizing the delivery of EP-104GI across the esophagus could yield further improvements. Such findings pave the way for Eupraxia to explore increased dosing levels and broader esophageal coverage in future cohorts.

With Cohort 7 fully enrolled, data is anticipated in the second quarter of 2025. The company plans to continue refining its approach with EP-104GI, aiming to establish it as a new standard treatment for EoE.

Eupraxia's innovative approach involves the use of DiffuSphere™, their proprietary technology designed for targeted, localized drug delivery. This technology helps in delivering extended-release formulations directly to the intended area, potentially reducing side effects compared to traditional drug delivery methods. The company's ongoing research and development efforts also include investigating applications in other therapeutic areas like oncology and other inflammatory diseases.

In conclusion, the RESOLVE trial continues to yield positive results, demonstrating significant potential for EP-104GI in treating EoE. With further research and exploration of increased doses and esophageal coverage, Eupraxia remains committed to advancing EP-104GI as a leading treatment option for this challenging condition.