Eupraxia Pharma Reports RESOLVE Trial Data on EP-104GI for Eosinophilic Esophagitis

Eupraxia Pharmaceuticals Inc., a clinical-stage biotechnology firm, has announced promising outcomes from its RESOLVE Phase 1b/2a trial, focusing on the safety and efficacy of EP-104GI for treating eosinophilic esophagitis (EoE). This trial leverages Eupraxia's proprietary DiffuSphere™ technology to optimize drug delivery in addressing significant unmet medical needs.

In the fourth cohort of the RESOLVE trial, 12 injections of EP-104GI, totaling 30 mg, were administered to less than two-thirds of the lower esophagus in each patient. The key findings reveal:
- The Straumann Dysphagia Index (SDI), which measures symptom severity based on patient reports, indicated a reduction for all three patients after administration, with peak decreases reaching up to four points or 67% from baseline. At 12 weeks post-administration, the SDI was reduced by a mean of 45%, or 3.3 points.
- The Eosinophilic Esophagitis Histology Scoring System (EoEHSS) showed the largest percent reduction in severity and extent of EoE for any cohort to date, with a mean 39% reduction in Composite Stage and a mean 37% reduction in Composite Grade at 12 weeks.
- Using data from four biopsy sites consistent with FDA guidelines, there was a mean reduction in Peak Eosinophil Counts (PEC) of 67% at 12 weeks.

Dr. James Helliwell, CEO of Eupraxia, expressed optimism about the positive efficacy and safety outcomes observed with EP-104GI, with expectations for further improvements as the trial progresses. The RESOLVE trial, a multicenter, open-label, dose-escalation study, aims to evaluate the safety, tolerability, pharmacokinetics, and efficacy of EP-104GI in adults with active, histologically confirmed EoE. The drug is administered via injections into the esophageal wall, with dose increases across successive cohorts. Participants in the first four cohorts will be monitored for up to 24 weeks, while those in later cohorts will be assessed for 52 weeks.

The trial's dose-escalation design is intended to explore the emerging dose-response relationship, with biopsies showing a correlation between drug dose and histological response. Dr. Helliwell highlighted that this is the anticipated outcome for a dose-escalation trial.

Dr. Evan S. Dellon, a University of North Carolina School of Medicine professor and chairman of Eupraxia's Gastrointestinal Clinical Advisory Board, acknowledged the positive trends in SDI, EoEHSS, and PEC scores as key data points for understanding esophageal health. He noted that EP-104GI's potential to improve overall esophageal health could be due to its injection into deeper esophageal tissues, aiding better esophageal remodeling.

The third cohort of the RESOLVE trial involved eight injections of EP-104GI, totaling 20 mg, administered to a portion of each patient's lower esophagus. Results showed:
- A 50% reduction in SDI in one of two evaluable patients at 24 weeks, with a third patient discontinuing for reasons unrelated to the study.
- EoEHSS Composite Stage and Composite Grade scores were lower than baseline at 12 weeks post-administration, with average reductions of 7% and 15%, respectively.
- A mean reduction in PEC of 55% at 12 weeks, consistent with FDA guidelines.

EoE is an inflammatory disease where white blood cells infiltrate the esophagus, causing pain and difficulty swallowing. Affecting over 450,000 individuals in the U.S., the disease's increasing incidence has been noted by the American Gastroenterological Association. The condition's symptoms and interventions often lead to mental health issues, adding to the disease burden.

Eupraxia Pharmaceuticals is dedicated to developing locally delivered, extended-release products to address therapeutic areas with high unmet medical needs. Their DiffuSphere™ technology aims to provide targeted, prolonged drug delivery, potentially reducing adverse events compared to traditional methods.

Eupraxia's EP-104GI is currently being evaluated in the RESOLVE trial for EoE treatment and has recently completed a Phase 2b trial for knee osteoarthritis. The company continues to develop advanced treatments for inflammatory diseases and other critical areas, leveraging its precision drug delivery technology.

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