At 52 weeks, 2 of 3 patients in Cohort 6 of Eupraxia’s RESOLVE trial remained in clinical remission on the Straumann Dysphagia Index after a single administration of EP-104GI (16 x 4 mg; 64 mg total). All three maintained symptom benefit with a mean SDI change of -3.7 (-58%). Pooled with Cohort 5, 4 of 6 patients were in clinical remission at 52 weeks. At week 36, across Cohorts 5–7 (n=9), 67% were in remission with a mean SDI reduction of -3.0 (-53%). Safety remains clean across more than 200 patient-months of follow-up, with no serious adverse events and no oral or gastrointestinal candidiasis. Plasma fluticasone levels were steady and below typical exposure observed with daily inhaled regimens.
The company released a second tranche of 52-week data from the ongoing open-label Phase 1b/2a RESOLVE study in eosinophilic esophagitis, while advancing a randomized, placebo-controlled Phase 2b portion now recruiting at a 120 mg dose (20 x 6 mg), with top-line results expected in Q3 2026. EP-104GI is delivered via multiple esophageal wall injections intended to provide localized, extended-release fluticasone with once-yearly durability.
Strategically, Eupraxia is carving out a procedural, long-acting steroid niche in an EoE market now shaped by chronic daily therapies and biologic options. The pitch is durability and adherence: a single visit aligned to routine endoscopy rather than daily swallowed steroids or frequent biologic dosing. That is a differentiated operational model but not without trade-offs. Open-label signals are numerically encouraging on symptoms with an unusually clean safety profile for a steroid, yet the n remains small and histology readouts are not highlighted here. With regulators and payers increasingly requiring concordance between symptom and histologic response in EoE, Phase 2b will need to show both, and to demonstrate that durable exposure does not drive local mucosal complications over time.
For sites, this approach shifts EoE management into endoscopy suites, creating procedural workflow and reimbursement implications. Standardizing a 4–20 injection technique, sedation protocols, and training across community and academic centers will matter for both trial execution and eventual adoption. Trial blinding and placebo control in an endoscopic injection paradigm also introduce operational complexities that CROs will need to anticipate, from sham procedures to consistent PRO capture using SDI. Central pathology and image adjudication will be pivotal if histology becomes a co-primary or hierarchical endpoint. For sponsors competing in EoE, a once-yearly localized steroid could pressure adherence-challenged daily regimens, but it will sit alongside dupilumab and newly approved oral budesonide formulations, making positioning and sequencing critical.
The next inflection is Phase 2b design execution and readout: dose selection at 120 mg, alignment of PRO and histology endpoints, and evidence of year-long durability without safety drift. Watch enrollment velocity and site mix, given the need for endoscopic capacity and procedural consistency. Manufacturing and CMC scale-up for a polymer microsphere steroid with tight release kinetics will be scrutinized early, as will any device-like handling steps that could trigger combination product oversight. If the randomized data reproduce the durability signal with histologic confirmation, the program could advance toward a maintenance strategy that complements or substitutes daily therapies. If not, questions around procedure burden, trial blinding, and competitive tolerance profiles will become harder to overcome.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
