AstraZeneca asthma drug Fasenra fails a main goal in phase 3 trial for esophagus disorder
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AstraZeneca (NASDAQ:AZN) on Tuesday said its drug Fasenra did not meet one of the two main goal goal of a phase 3 trial to treat patients aged 12 to 65 years of age with symptomatic and histologically active eosinophilic esophagitis (EoE).
EoE is a rare, chronic inflammatory disease of the esophagus characterized by the abnormal build up of a type of white blood cells called eosinophils in the inner lining of the esophagus. Patients experience difficulty while swallowing (dysphagia), and pain, among other symptoms.
In the study, dubbed MESSINA, Fasenra showed a statistically significant improvement in histological disease remission, but not a change in swallowing (dysphagia) symptoms, compared to placebo, in patients with EoE aged 12 years or older.
The British pharma giant said 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.
Meanwhile, burden of swallowing was evaluated using the patient-reported Dysphagia Symptom Questionnaire (DSQ) and measured as an average change from baseline at week 24, the company added.
The study included 210 patients, who received either Fasenra (benralizumab) or placebo at four-week intervals.
"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," said Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AstraZeneca.
AstraZeneca added that safety and tolerability profile for Fasenra in the trial was consistent with the known profile of the drug.
Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the U.S., EU, Japan and certain other countries.
In March, the U.S. FDA declined to approve Fasenra to treat patients with inadequately controlled chronic rhinosinusitis with nasal polyps.