Eupraxia Pharmaceuticals Inc. announced positive clinical data from its Phase 1b/2a RESOLVE trial, which is evaluating safety and efficacy of EP-104GI as a treatment for eosinophilic esophagitis (EoE). The results announced from the first cohort of the RESOLVE trial, treating EOE using Eupraxia's DiffusphereTM technology, are derived from a low initial dose of four 1 mg injections of EP-104GI injected in a small portion of each patient's lower esophagus. The data indicate efficacy signals at this initial, low dose.

The cohort's first patient had very severe disease in the distal esophagus (where the injections were given) and on entry into the trial had severe difficulty swallowing (dysphagia), and significant pain on swallowing (odynophagia) with frequent bouts of vomiting. Within two weeks, these symptoms had been reduced significantly. This patient has maintained this high degree of response until week 12 of the trial where they remain asymptomatic.

The other two patients in this cohort had diffuse disease throughout the esophagus (far away from where the injection occurred) and therefore Eupraxia did not expect any clinical response. Both patients showed meaningful improvement in their dysphagia and odynophagia scores after treatment in addition to improvements in their Strauman Dysphagia Index scores. Histology results in all patients are inconclusive in this first cohort.

These results from the first cohort of a very low dose of EP-104GI in a small area of the esophagus has resulted in meaningful symptom improvement in all patients to at least 12 weeks. This response is believed to be indicative of the potential for higher doses to spread more diffusely through the esophagus and provide a more pronounced and prolonged response in this difficult-to-treat population. The Company has previously announced that based on its first external safety review meeting of the RESOLVE trial, the original timeline of the trial was extended to six months to fully characterize the duration of efficacy.

As is evident by the continued meaningful improvement at three months in this first cohort with a low dose, Eupraxia is looking forward to following patients in this and subsequent cohorts to six months. The second cohort of the RESOLVE trial has been fully recruited and the dosing doubled from the initial cohort, with eight 1 mg injections offering broader coverage of the esophagus. The trial's second cohort has now been fully dosed and further results are expected in the first quarter of 2024.

The Company anticipates also releasing additional interim data as the study progresses.