Early signals from the highest planned dose in Eupraxia’s RESOLVE study point to stronger efficacy without new safety concerns. In the open-label dose-escalation cohorts, patients receiving 8 mg per injection showed the largest improvements to date in EoEHSS tissue scores and eosinophil reduction, with more biopsy sites achieving ≤6 eos/hpf. Clinical remission by SDI appeared rapidly, durability persisted on follow-up, and across all treated patients to date, the company reports no serious adverse events and no candidiasis.
On the back of those data, Eupraxia will add an 8 mg-per-injection regimen as the second active arm in the randomized, placebo-controlled Phase 2b portion of RESOLVE, delivered as 20 esophageal wall injections per administration for a 160 mg total dose. The Phase 2b study, which already includes a 120 mg total-dose arm (20 x 6 mg), will expand from 60 to at least 120 patients, targeting a minimum of 40 participants per group. The Safety Committee has cleared the higher dose, and the company plans to disclose additional open-label data in Q4 2025, with Phase 2b top-line expected in Q3 2026. Proceeds from a recent financing will also fund program expansion, including nonclinical work to enable repeat dosing and adolescent inclusion in Phase 3, and a trial in an additional GI indication in the first half of 2026.
Strategically, this is a commitment to a higher-exposure, procedure-based approach in EoE, leaning into a perceived dose–response while building a larger safety and efficacy set that could support a Breakthrough Therapy request and a single pivotal path. The expansion into fibrostenotic Crohn’s and benign or prophylactic esophageal stricture settings suggests Eupraxia is testing the broader thesis for localized, extended-release steroid delivery where tissue remodeling is central and systemic therapies or topical steroids fall short. The company is also positioning around durability and mucosal health improvement signals that, if reproduced in a randomized setting, could differentiate against existing options dominated by biologics and swallowed steroids.
Operationally, the plan will test whether sites can execute a 20-injection esophageal regimen at scale. This is an endoscopy-based workflow with implications for training, sedation, procedure-room availability, and consistent technique across centers. Central histopathology and rigorous PRO capture will be pivotal, particularly given reliance on SDI-defined clinical remission rather than instruments more commonly seen in prior EoE registrational programs. The expanded sample size should help with statistical power and a more credible safety database, but it also raises recruitment demands and procedural throughput requirements that will fall heavily on high-volume GI centers.
For regulators, the questions are straightforward: can the randomized Phase 2b deliver concordant symptomatic and histologic benefit with durability, and is the effect size meaningfully better than available therapies to justify expedited pathways? Inclusion of adolescents will be important for a commercially relevant label, while repeat-dosing data will need to address steroid exposure and long-term tissue effects. For payers and providers, the trade-off will be a procedural intervention that may reduce candidiasis and improve tissue outcomes versus the convenience of systemic or topical options.
The next catalysts are the Q4 2025 open-label update and the Q3 2026 Phase 2b readout. Watch for quantification of SDI and EoEHSS effects, procedure-related AE rates with 20 injections, early signs on fibrosis-related endpoints, and clarity on FDA alignment around endpoints and adolescent bridging. If the signal holds in the randomized setting, the higher dose and expanded dataset could support a streamlined Phase 3; if not, the procedural burden may become a gating factor for both development and adoption.
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.
