AstraZeneca’s Treatment for Rare Throat Disease, Eosinophilic esophagitis, Fails Primary Endpoint

AstraZeneca announced that its clinical trial evaluating a treatment for the rare disease Eosinophilic esophagitis did not meet one of its two primary endpoints. The treatment, Fasenra (benralizumab), demonstrated inferior results in dysphagia symptom reduction compared to the placebo. 

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One out of Two Primary Endpoints Met

Eosinophilic esophagitis is a rare chronic disease characterized by inflammation of the esophagus. The disease is caused by the presence of a kind of white blood cell known as eosinophils in the esophagus. Symptoms include difficulty swallowing (dysphagia), pain, food getting stuck, and anxiety.

AstraZeneca initiated the Phase 3 MESSINA clinical trial, examining the usage of Fasenra as a treatment for the rare disease. The monoclonal antibody binds to the eosinophils’ IL-5 receptor, inducing programmed cell death through the rapid and near-complete depletion of blood and tissue in the white blood cells. Fasenra currently holds an approval as an add-on maintenance treatment for Severe Eosinophilic Asthma in the United States, European Union, and Japan, as well as other countries. 

The Phase 3 trial had two primary endpoints: improvement in histological disease remission and a reduction in dysphagia symptoms. Although MESSINA demonstrated a “significant improvement” in histological disease remission, compared to the placebo, it did not see similar results in improving dysphagia symptoms.

On the results, Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D at AstraZeneca, said, “The results from the MESSINA Phase 3 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 analyze the complete data set to share with the scientific community.”

Despite falling short of one of its primary endpoints, the MESSINA trial demonstrated a safety and tolerability profile consistent with the known profile of the medicine.

Going forward, AstraZeneca intends to present the full results of the clinical trial at an upcoming medical meeting. It is unknown if the company intends on moving forward with continue testing of the treatment. 

Author

Max Heirich