MESSINA Phase III trial of Fasenra fails to meet one of dual-primary endpoints in eosinophilic esophagitis

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. 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. Results from MESSINA will be presented at an upcoming medical meeting.

The trial period consists of a 24-week double-blind, placebo-controlled treatment period followed by a 28-week open-label treatment period. Eligible patients were randomised in a 1:1 ratio to receive either 30 mg of Fasenra or placebo at 4-week intervals for the double-blind period. Patients who complete the double-blind period on Fasenra continue into the open-label treatment period with all patients receiving Fasenra 30 mg at 4-week intervals until Week 52, with a further open-label extension offered to eligible patients thereafter. In the trial, patients were allowed to remain on background medications for EoE, including proton pump inhibitors, topical corticosteroids, and EoE-driven diet elimination, provided that they were stable prior to entry and during the first 52 weeks of treatment, unless changes were clinically indicated.