AstraZeneca Asthma drug Fasenra fails one main goal in study of chronic immune disease
UK: 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 Eosinophilic esophagitis (EoE) aged 12 years or...
UK: 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 Eosinophilic esophagitis (EoE) aged 12 years or older.
Eosinophilic esophagitis 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.
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. The 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.
Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan, and other countries, and is approved for self-administration in the US, EU, and other countries.
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