Eupraxia's DiffuSphere™ Study: Advancing Targeted Drug Delivery for Chronic Conditions Eupraxia, a clinical-stage biotechnology company developing locally delivered, extended-release products to address unmet medical needs, shared new data from its Phase 2a Eosinophilic Oesophagitis (EoE) program in the Lancet Rheumatology Journal. The current study assesses the efficacy of injecting the oesophagus during endoscopy to deliver slow-release fluticasone to achieve EoE remission for 6 to 12 months. EoE is a chronic, immune-mediated condition with increasing incidence and prevalence in recent years. It often requires lifelong management and treatment. Symptoms include difficulty swallowing (dysphagia), food impaction, and chest pain, particularly in adults, leading to hospitalisation visits. Mental health challenges often compound the disease burden for patients and the healthcare system. DiffuSphere™ Technology DiffuSphere™ is Eupraxia's proprietary polymer-based microsphere technology behind treatments like EP-104GI for gastrointestinal conditions (e.g., EoE) and EP-104IAR for knee osteoarthritis (OA). The technology enables extended drug delivery, precisely targeting specific tissues for a focused, long-lasting effect, minimising side effects linked to high-dose systemic delivery. DiffuSphere™ uses a pure drug crystal encased in a microscopically thin polymer shell. This design promises steady drug release, maintaining high concentrations in target tissues and minimising exposure to the rest of the body. James Helliwell, Co-founder and CEO of Eupraxia Pharmaceuticals: “Eupraxia Pharmaceuticals is excited about our program treating EOE using our Diffusphere technology combined with Fluticasone Propionate. As a physician who worked with high-risk cardiac patients it was so clear that finding medications that were stable, targeted and safe was absolutely critical for good outcomes while reducing side effects and convenience was the best way to ensure patient satisfaction and compliance. With what we expect to be a once-annual treatment done during routine endoscopy EP104GI, we hope to reduce symptoms of EOE, improve the tissue health of the oesophagus and have few to no off-target effects. We look forward to helping in this complex disease and improving patients' lives.” Study Design RESOLVE Trial (Human Study): RESOLVE is a Phase 1b/2a, multicentre, open-label, dose-escalation human study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of EP-104GI in adults with histologically confirmed active EoE. EP-104GI is administered as a single dose via four to 20 injections into the oesophageal wall. Dose escalations increase the dose per site and/or number of sites. Cohorts: Cohorts 1–4 were assessed over 24 weeks. Cohorts 5 and above were assessed for up to 52 weeks. Preclinical Pig Study A non-clinical pig study was conducted to validate DiffuSphere™'s ability to localise drug delivery and minimise systemic exposure. This study compared local and systemic fluticasone levels following intraoesophageal injection versus oral gavage. RESOLVE Trial Results Treatment Duration: when injected into the oesophageal wall (submucosa), EP-104GI demonstrated a treatment duration exceeding six months from a single injection with predictable dose control. Cohort 1 (4 mg FP): Drug levels maintained at 1.5 pg/ml for six months. Cohort 5 (48 mg FP): Drug levels reached 10 pg/ml at three months. Clinical Improvements: Key EoE disease measures improved, including patient symptoms, oesophageal tissue health, and eosinophil counts. Preclinical Pig Study Findings The study revealed that oesophageal tissue levels of fluticasone were more than 1000 times higher in the EP-104GI group compared to the oral gavage group, even at distances of several centimetres from the injection sites. Despite significantly higher local concentrations, systemic levels of fluticasone in the plasma were lower in the EP-104IAR group than in the oral gavage group. Results were Presented at the American College of Gastroenterology meeting (poster). Read in Lancet Journal Eupraxia Pharmaceuticals LLC Press Release Authors: Amanda Malone, PhDa, Mark M Kowalski, MDa, James Helliwell, MDa, Sidsel Lynggaard Boll, MDb, Helene Rovsing, MDc, Kathrine Moriat, MDd, Alejandro Castillo Mondragón, MDe, Yanqi Li, PhDe, Claire Prener Miller, MDe, Asger Reinstrup Bihlet, PhDe, Christine Dobek, MSca, Vik Peck, BSca, Mike Wilmink, MDf, Lee S Simon, MDg, Prof Philip G Conaghan, MBBS Relevant publications: Eosinophilic Oesophagitis Prevalence and Costs: Key Findings from U.S. Study Phase 3 Study of Cendakimab for Eosinophilic Oesophagitis (EoE): Key Findings Access to Dupixent (Dupilumab) Treatment in the UK Explained Eosinophilic Diseases Research: Past, Present and Future Manage Cookie Preferences