The pharmaceutical company AstraZeneca has announced that patients have been given the first doses of Fasenra (benralizumab) in Phase 3 trial MESSINA evaluating the drug as a treatment for Eosinophilic Oesophagitis (EoE). 

The 52-week treatment period will first entail 24 weeks of double-blind placebo-controlled treatment, then 28 weeks open-label. The Primary Completion date expected March 2022 and the Study Completion date expected November 2023.

The drug is being assessed in 9 further Phase 2 and 3 trials in other eosinophil-related diseases. AstraZeneca also announced that there is a Phase 3 trial planned for Fasenra in Eosinophilic Gastritis (EG) and Eosinophilic Gastroenteritis (EGE).

Primary Outcomes

It is proposed that Fasenra will deplete eosinophils from gastrointestinal tissue, improve the symptoms of dysphagia, and improve endoscopy scores and other markers of disease activity. The trial's two primary outcomes are:

1. The proportion of patients with a histologic response at Week 24, defined as a peak oesophageal intraepithelial eosinophil count ≤ 6 eos/hpf
2. Changes from baseline in Dysphagia Symptom Questionnaire

Because Fasenra depletes eosinophils in blood and tissue, it could become a potential new medicine to treat patients with this rare disease.

 - Mene Pangalos, Executive Vice President, AstraZeneca BioPharmaceuticals R&D

Fasenra

Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, UK, EU, Japan and other countries. It is a monoclonal antibody that binds directly to the IL-5 receptor alpha on eosinophils. It attracts natural killer cells to induce rapid and near-complete depletion of eosinophils via apoptosis (programmed cell death).

Links

• MESSINA study outline
• Fasenra granted US Orphan Drug Designation for EoE
• Further Fasenra trials in eosinophil-related diseases

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