The Phase 1b/2a RESOLVE clinical study set out to identify how safe and effective EP-104GI is for people living with a chronic immune-mediated disease called eosinophilic esophagitis (EoE). People with EoE experience high levels of eosinophils (a type of white blood cell) in their esophagus because of immune hypersensitivity or environmental allergens. This leads to symptoms such as dysphagia (difficulty swallowing), food impaction, abdominal pain, appetite loss, nausea and vomiting, failure to thrive, weight loss, and malnutrition. EoE can be managed using dietary changes and medications like proton pump inhibitors. But as of right now, there is no cure for EoE, so identifying novel treatments in clinical studies could profoundly change the treatment landscape.

Biotechnology company Eupraxia Pharmaceuticals Inc. (“Eupraxia”) shared that EP-104GI seemed to perform well in the Phase 1b/2a trial. The available results focus on the first two treated cohorts. Participants received either four 1mg EP-104GI injections or eight injections, which were administered to the lower esophagus. Study data shows that:

• EP-104GI showed signs of improving difficult and painful swallowing within a 24-week period.
• While some adverse events occurred during the trial, investigators determined that these were most likely unrelated to the treatment. This suggests that the treatment is well-tolerated.
• EP-104GI also reduced eosinophil levels.

Additional data, including data from cohort three (who received eight 2.5mg EP-104GI injections), should be available at a later point in time. Preliminary data from cohort 3 suggests that EP-104GI reduces negative symptoms associated with eosinophilic esophagitis.

The Details on EP-104GI for Eosinophilic Esophagitis

EP-104GI is delivered using Eupraxia’s proprietary polymber-based Diffusphere™ technology which maintains a constant drug concentration. Eupraxia explains that:

EP-104 is positioned as an ideal candidate to address the debilitating symptoms of EoE [and] is designed to slowly release drug to affected areas, maximizing therapeutic action at the site and minimizing undesirable effects. For patients with EoE, this means potential for longer-lasting, effective intervention that is anticipated to be a well-received alternative to current options.

Outside of eosinophilic esophagitis, Eupraxia is also developing EP-104 for osteoarthritis; this form is known as EP-104IAR. The therapy, which encapsulates a highly potent corticosteroid called fluticasone propionate within a microns-thin polymer membrane, aims to provide pain relief.