Eupraxia Pharmaceuticals’ EP-104GI shows efficacy in follow-up esophagitis data

Eupraxia Pharmaceuticals (EPRX) announced the second set of 52-week follow up data from its ongoing Phase 1b/2a RESOLVE trial evaluating a single administration EP-104GI for the treatment of eosinophilic esophagitis, or EoE. Cohort 5 & 6 patients – the only groups to have reached 52 weeks in the trial – are demonstrating levels of symptom relief that is durable and clinically meaningful. Two of three patients treated in Cohort 6 were in clinical remission at weeks 12, 24, 36 and 52. All patients in Cohort 6 maintained symptom improvements at week 52, with an average reduction in SDI scores of -3.7, or -58%. At week 36, across Cohorts 5-7, 67% of patients were in clinical remission, with an average reduction in SDI scores of -3.0, or -53%. Plasma levels of fluticasone in patients treated in Cohort 6 remained constant and predictable out to 52 weeks. This is well below levels typically observed with daily asthma inhalers. There have been no head-to-head trials with EP-104GI and daily asthma inhalers. With now over 200 patient-months of follow-up across all cohorts, no SAEs or cases of oral or gastrointestinal candidiasis reported to date.