EP-104GI's Phase 2b RESOLVE readout will test whether local corticosteroid delivery can durably control EoE without the systemic risks of biologics

Bull

A positive outcome would show statistically significant histological remission (peak eosinophil count ≤15 eos/hpf) and sustained symptom response (SDI reduction ≥3 points) at the primary endpoint timepoint across the 120mg and/or 160mg dose arms, consistent with Phase 1b/2a signals. This would confirm dose-response durability, validate the delivery platform, and position EP-104GI as a steroid-based alternative to biologics — potentially enabling a pivotal Phase 3 design and attracting partnership interest from gastroenterology-focused acquirers.

Bear

The most likely failure modes are insufficient histological response rate at the higher doses in the expanded Phase 2b population, loss of the dose-response signal seen in the small Phase 1b/2a cohorts, or meaningful procedural variability in esophageal drug coverage that dilutes efficacy in intent-to-treat analysis. A secondary concern is that durability beyond 36 weeks — the key differentiation claim versus swallowed topical corticosteroids — may not be adequately demonstrated within the trial's readout window, undermining the 'durable control' pillar of the thesis.