*EMBARGOED All research presented at the 2024 ACG Annual Scientific Meeting and Postgraduate Course is strictly embargoed until Sunday, October 27, 2024, at 12:00 pm ET.
P3911 – Efficacy and Pharmacokinetic Results From Ongoing Dose Escalation in RESOLVE, a Phase 1b/2a Study of EP-104GI (Extended-Release Fluticasone Propionate Intra-Esophageal Injection) for Eosinophilic Esophagitis
Tuesday, October 29, 2024 | 10:30 AM – 4:00 PM ET | Exhibit Hall E
Author Insight from Amanda Malone, PhD
What’s new here and important for clinicians?
EP-104GI is an injectable suspension of polymer-coated fluticasone propionate (FP) crystals designed to deliver FP, an anti-inflammatory corticosteroid, at a consistent pre-defined rate at the injection site with a low initial peak concentration and extended period of release. EP-104GI has the potential to offer an extended period of symptom relief and histologic improvement for patients with eosinophilic esophagitis (EoE), with fewer side effects than currently available swallowed corticosteroid treatment.
In the initial 4 dose escalation cohorts of the ongoing RESOLVE Phase 1b/2a clinical study, EP-104GI has been well tolerated without drug-related adverse events or symptoms of adrenal insufficiency. By 12 weeks post-dose, 10/11 patients with available data showed a decrease from baseline in symptoms by 2 to 6 points (25% to 100%) assessed via the Straumann Dysphagia Index. Histological assessments at Week 12 show 7/11 patients with data available had reduced mean Peak Eosinophil Counts (PEC) and EoE Histologic Scoring System composite grade and stage at injection-area sites. Data from 4 biopsy sites with the greatest decrease from baseline (of 16 assessed), showed a mean reduction in PEC of 67% at 12 weeks in cohort 4.
What do patients need to know?
EP-104GI is an investigational treatment for patients with EoE which is injected into the esophagus. EP-104GI uses a novel method to deliver the active ingredient (corticosteroid) over an extended period of time by diffusion. The aim of EP-104GI is to provide relief of EoE symptoms and effects of the disease on the esophagus with at least 6 months between injections and fewer side effects than swallowed corticosteroid.
The RESOLVE clinical study is investigating increasing doses of EP-104GI in adult patients with EoE. RESOLVE is currently recruiting patients and continuing to increase the dose of EP-104GI. In the first 4 cohorts of the study, EP-104GI has been safe and the majority of patients have experienced reduced symptoms from EoE along with improvements in the effects of the disease measured from biopsies.
Author Contact
Amanda Malone, PhD
Eupraxia Pharmaceuticals
Victoria, British Columbia, Canada
amalone [at] eupraxiapharma.com
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