Eupraxia Pharmaceuticals (TSX:EPRX; NASDAQ:EPRX) announced positive clinical data from the fifth cohort of its RESOLVE Phase 1b/2a trial, a multi-center, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of EP-104GI for the treatment of adults with histologically confirmed active eosinophilic esophagitis (EoE).
The latest positive results stem from a regimen of 12 injections, each delivering 4 mg of EP-104GI (total dose of 48 mg), administered to the lower two-thirds of each patient’s esophagus.
Additionally, the company reports that plasma fluticasone levels remain predictable and well below the levels observed in daily fluticasone asthma treatments.
As the RESOLVE trial advances, we are observing increasingly positive data on efficacy and safety outcomes, including no adverse events such as candidiasis, adrenal suppression or glucose derangement,” said Dr. James Helliwell, CEO of Eupraxia.
“Notably, higher dosing levels are yielding improved patient responses, such as histological remission, enhanced patient-reported symptom scores, and favourable histology results, all without reaching a maximum tolerated dose thus far,” Dr. Helliwell added.