Eupraxia Pharmaceuticals (NASDAQ:EPRX) reported positive interim data from its ongoing Phase 1b/2a RESOLVE trial evaluating EP-104GI in patients with eosinophilic esophagitis.
In the highest-dose cohort (8mg per site across 20 sites, n=3), treatment at 12 weeks resulted in near-complete tissue normalization, with Eosinophilic Esophagitis Histology Scoring System (EoEHSS) grade scores improving by -0.57 (94% reduction) and stage scores by -0.63 (97% reduction).
Patients in the 4mg-per-site cohorts (n=9) demonstrated sustained benefits, maintaining 12-week improvements at 36 weeks with grade score improvements of -0.22 and stage score improvements of -0.24.
Among patients with at least 60% of the esophagus treated, clinical remission rates reached 58% at 12 weeks (n=19), increased to 79% at 24 weeks (n=14), and stood at 67% at 52 weeks (n=6).
The safety profile also remained favorable across more than 200 patient-months of exposure in 31 patients, with no serious adverse events and no reports of oral candidiasis.