Eupraxia Begins Phase 2b EP-104GI Trial for Eosinophilic Esophagitis

Eupraxia Pharmaceuticals Inc., a biotechnology company based in Victoria, Canada, has recently marked a significant milestone in its clinical research efforts with the administration of the first dose in the Phase 2b segment of the RESOLVE clinical trial. This trial focuses on EP-104GI, a potential treatment for eosinophilic esophagitis (EoE), a chronic inflammatory condition of the esophagus. By using its proprietary DiffuSphere™ technology, Eupraxia aims to enhance controlled, localized drug delivery, thereby reducing systemic side effects commonly associated with traditional steroid treatments.

The Phase 2b portion of the RESOLVE trial will involve at least 60 participants who will be randomly assigned to one of three groups, receiving either one of two doses of EP-104GI or a placebo. Participants will undergo treatment for six months, after which those initially given a placebo may have the option to receive EP-104GI. The primary goal of this phase is to evaluate the effectiveness of EP-104GI in improving esophageal tissue health, utilizing the Eosinophilic Esophagitis Histology Scoring System (EoEHSS) as a metric. Secondary objectives include assessing symptom relief based on patient feedback, as well as analyzing endoscopic and histological changes, such as the Peak Eosinophil Count (PEC), along with evaluating the pharmacokinetics and overall safety of the treatment.

The trial will be conducted at up to 25 global sites and features an adaptive design to optimize dosing. The first dose was chosen based on data from previous segments of the study, particularly cohort 8, which involved a 120 mg dose, achieved through 20 injections of 6 mg each. The safety and efficacy of this dose, supported by data, prompted its selection as the initial treatment dose. Further evaluation will determine the second dose based on additional long-term data.

James Helliwell, CEO of Eupraxia Pharmaceuticals, expressed optimism regarding the advancement of EP-104GI, highlighting its potential to transform the current treatment landscape for EoE. This progress is critical for the company as it moves towards the pivotal trials required for regulatory approval.

The Safety Review Committee conducted a thorough analysis of the existing safety, pharmacokinetic, and efficacy data, particularly highlighting the encouraging results from cohort 8. These results showed significant improvements in PEC and EoEHSS scores within four weeks, along with an absence of serious adverse events, thrush, and alterations in cortisol or glucose levels.

Eupraxia plans to release further detailed data regarding histological scores, symptom responses, and safety profiles for cohort 8 in the third quarter of this year as more data becomes available. The company will continue to report findings from the open-label portion of the study, providing insights at various time intervals as the Phase 2b study progresses. Complete data from this portion of the study is anticipated by the third quarter of 2026.

The RESOLVE trial encompasses two main phases: a Phase 1b/2 multicenter study evaluating the safety and efficacy of EP-104GI in adults with active EoE. The trial involves escalating doses administered via esophageal wall injections. In the latter part, two doses will be compared against a placebo over a period of up to 52 weeks, with assessments at multiple intervals.

EoE is marked by white blood cell infiltration in the esophagus, causing pain and swallowing difficulties. It affects over 450,000 individuals in the U.S. and is recognized by the American Gastroenterological Association as a rapidly growing concern. Eupraxia’s approach, using its innovative DiffuSphere™ technology, aims to provide effective treatments with fewer adverse effects, offering hope for improved management of this condition.