MESSINA did not meet one of the two dual-primary endpoints, demonstrating a statistically significant improvement in histological disease remission with Fasenra, but not in dysphagia symptoms, compared to placebo

Eosinophilic esophagitis (EoE) is a rare, progressive, chronic inflammatory disease of the esophagus currently believed to be characterised by the abnormal presence of eosinophils, a type of white blood cell, in the inner lining of the esophagus. Patients experience difficulty with swallowing (dysphagia), pain, food getting stuck and anxiety.

High-level results from the MESSINA Phase III trial showed that AstraZeneca's Fasenra (benralizumab) did not meet one of the two dual-primary endpoints. Fasenra demonstrated a statistically significant improvement in histological disease remission, but not a change in dysphagia symptoms, compared to placebo, in patients with EoE aged 12 years or older.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca said: “The results from the MESSINA Phase III trial in eosinophilic esophagitis confirm that Fasenra achieved near complete depletion of tissue eosinophils, consistent with its mechanism of action, however this did not translate into an improvement in dysphagia symptoms. We will continue to analyse the complete data set to share with the scientific community.”

In the trial, histological disease remission was measured as the proportion of patients with less than or equal to six eosinophils per high power field at Week 24. Burden of dysphagia was assessed using the patient-reported Dysphagia Symptom Questionnaire (DSQ) and measured as a mean change from baseline at Week 24. The trial included 210 patients, who received either Fasenra or placebo at four-week intervals.

The safety and tolerability profile for Fasenra in the trial was consistent with the known profile of the medicine.

Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan and other countries,6 and is approved for self-administration in the US,6 EU7 and other countries.