Eupraxia Reports Positive Data from Phase 1b/2a Trial of EP-104GI for Eosinophilic Esophagitis

Eupraxia Pharmaceuticals Inc. has announced encouraging clinical data from its ongoing RESOLVE Phase 1b/2a trial, which is assessing the safety and efficacy of EP-104GI for the treatment of eosinophilic esophagitis (EoE). The latest results pertain to the trial's fourth and fifth cohorts, providing meaningful insights into the treatment's potential benefits.

The fifth cohort received a regimen of 12 injections of EP-104GI totaling 48 mg administered to the lower two-thirds of their esophagus. Remarkably, one patient achieved complete histological remission, defined as having fewer than six eosinophils per high-powered field on an esophageal biopsy. All three patients in this cohort reported reduced symptoms as measured by the Straumann Dysphagia Index (SDI), with decreases up to three points from baseline, translating to a mean reduction of 41% at 12 weeks.

The Eosinophilic Esophagitis Histology Scoring System (EoEHSS) indicated the most significant reduction in severity and extent of EoE seen across all cohorts so far, with a peak reduction of 100% in Stage and Grade scores and a mean reduction of 54%. Additionally, the mean reduction in Peak Eosinophil Counts (PEC) across four biopsy sites was 83% at the 12-week mark. Plasma levels of fluticasone, the active drug in EP-104GI, remained well below those found in daily asthma treatments.

Dr. James Helliwell, CEO of Eupraxia, emphasized the positive trajectory of the trial, noting the increasingly favorable safety and efficacy outcomes, including the absence of adverse events like candidiasis, adrenal suppression, or glucose derangement. Higher dosing levels have shown enhanced patient responses in terms of histological remission and symptom improvement without reaching a maximum tolerated dose.

The trial, a multicenter, open-label, dose-escalation study, aims to evaluate the safety, tolerability, pharmacokinetics, and efficacy of EP-104GI in adults with active EoE. The treatment is administered via four to 20 injections into the esophageal wall, with dose escalations increasing the dose per site or the number of sites. Participants in the first through fourth cohorts have been evaluated for up to 24 weeks, while those in the fifth and subsequent cohorts will be assessed for 52 weeks.

Furthermore, the fourth cohort, which received 30 mg of EP-104GI through 12 injections, has shown continued improvement in patient-reported outcomes at the 24-week mark, with an average four-point reduction in SDI scores — the largest reduction noted so far. EoEHSS Composite Stage and Grade scores also fell by 39% and 37%, respectively, at 12 weeks post-administration. The mean reduction in PEC was 67% at 12 weeks, compared to a 55% reduction in the third cohort.

EoE is an inflammatory disease where white blood cells become trapped in the esophagus, causing pain and difficulty swallowing. Affecting over 450,000 people in the United States, its incidence is rapidly increasing, and it often leads to significant mental health challenges due to the impact of symptoms and treatments.

Eupraxia Pharmaceuticals, a clinical-stage biotech company, focuses on developing locally delivered, extended-release products to address unmet medical needs. Their proprietary DiffuSphere™ technology aims to deliver drugs in a targeted, sustained manner, potentially reducing adverse events and enhancing efficacy. This technology has applications across various therapeutic areas, including pain, inflammatory gastrointestinal diseases, oncology, and infectious diseases.

EP-104GI's ongoing Phase 1b/2a trial for EoE and the recently completed Phase 2b trial (SPRINGBOARD) for knee osteoarthritis reflect Eupraxia's commitment to advancing treatments for conditions with high unmet needs. Their pipeline also includes candidates for other inflammatory joint indications and oncology, all designed to improve on existing drugs' activity and tolerability.