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AstraZeneca PLC on Tuesday said that its Fasenra treatment failed to meet one of its two primary endpoints in its Messina Phase 3 trial in eosinophilic esophagitis.
The Cambridge-based pharmaceutical company said that while Fasenra demonstrated a "statistically significant improvement" in histological disease remission, it did not show a change in dysphagia symptoms compared to placebo. Dysphagia is difficulty swallowing.
This means that although cells affected by the disease showed improved signs of recovery, this did not lead to a reduction in reported symptoms of the disease.
Eosinophilic esophagitis is a chronic immune system disease in which a type of white blood cell, an eosinophil, builds up in the lining of the tube that connects the mouth to the stomach. This build-up can inflame or injure the tube tissue which can lead to difficulty swallowing.
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.
Mene Pangalos, executive vice president of biopharmaceuticals, 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."
Shares in AstraZeneca were down 0.1% at 9,768.00 pence each in London on Tuesday morning.
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