Update on the MESSINA Phase III trial for Fasenra in eosinophilic esophagitis
MESSINA didn’t meet one of the two binary-primary endpoints, demonstrating a statistically significant enhancement in histological complaint absolution with Fasenra, but not in dysphagia symptoms, compared to placebo
Eosinophilic esophagitis( EoE) is a rare, progressive, habitual seditious complaint of the esophagus presently believed to be characterised by the abnormal presence of eosinophils, a type of white blood cell, in the inner filling of theesophagus.1- 3 Cases experience difficulty with swallowing( dysphagia), pain, food getting wedged and anxiety.4, 5
High- position results from the MESSINA Phase III trial showed that AstraZeneca’s Fasenra( benralizumab) didn’t meet one of the two binary-primary endpoints. Fasenra demonstrated a statistically significant enhancement in histological complaint absolution, but not a change in dysphagia symptoms, compared to placebo, in cases with EoE aged 12 times or aged.
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 reduction of towel eosinophils, harmonious with its medium of action, still this didn’t restate into an enhancement in dysphagia symptoms. We’ll continue to assay the complete data set to partake with the scientific community. ”
In the trial, histological complaint absolution was measured as the proportion of cases with lower than or equal to six eosinophils per high power field at Week 24. Burden of dysphagia was assessed using the case- reported Dysphagia Symptom Questionnaire( DSQ) and measured as a mean change from birth at Week 24. The trial included 210 cases, who entered either Fasenra or placebo at four- week intervals.
The safety and tolerability profile for Fasenra in the trial was harmonious with the known profile of the drug.
Results from MESSINA will be presented at an forthcoming medical meeting.
Fasenra is presently approved as an add- on conservation treatment for severe eosinophilic asthma in the US, EU, Japan and other countries, 6 and is approved for tone- administration in the US, 6 EU7 and other countries.
MESSINA is a randomised, placebo- controlled, double-eyeless, resemblant- group, multicentre, global Phase III trial designed to probe the efficacity and safety of Fasenra compared to placebo in cases progressed 12 to 65 times of age with characteristic and histologically active EoE.8, 9
The binary-primary endpoints analysed at Week 24 were the proportion of cases with a histologic response, defined as a peak esophageal eosinophil count lower than or equal to 6 eosinophils per high power field, and mean changes from birth in Dysphagia Symptom Questionnaire( DSQ).8 The peak eosinophil count is attained when a vivisection of the towel of the esophagus is examined under a microscope. The histologic response endpoint used in the trial is harmonious with histologic absolution.10 The DSQ captures the presence and inflexibility of dysphagia symptoms in the once day in a 4- item case- reported questionnaire and the score is calculated over 14- day ages, ranging from 0 to 84, with a lower score indicating less severe dysphagia.8
The trial period consists of a 24- week double-eyeless, placebo- controlled treatment period followed by a 28- week open- marker treatment period.8 Eligible cases were randomised in a 11 rate to admit either 30 mg of Fasenra or placebo at 4- week intervals for the double-eyeless period. Cases who complete the double-eyeless period on Fasenra continue into the open- marker treatment period with all cases entering Fasenra 30 mg at 4- week intervals until Week 52, with a further open- marker extension offered to eligible cases later.9
In the trial, cases were allowed to remain on background specifics for EoE, including proton pump impediments, topical corticosteroids, and EoE- driven diet elimination, handed that they were stable previous to entry and during the first 52 weeks of treatment, unless changes were clinically indicated.8, 9
Fasenra( benralizumab) is a monoclonal antibody that binds directly to IL- 5 receptor nascence on eosinophils and attracts natural killer cells to induce rapid-fire and near-complete reduction of blood and towel eosinophils in utmost cases via apoptosis( programmed cell death).11
Fasenra is presently approved as an add- on conservation treatment for severe eosinophilic asthma in the US, EU, Japan and other countries, 6 and is approved for tone- administration in the US, 6 EU7 and other countries. Fasenra has been studied in nearly,000 cases in global clinicaltrials.12- 16
Fasenra is in development for other eosinophilic conditions including bullous pemphigoid, habitual obstructive pulmonary complaint, habitual rhinosinusitis with nasal cysts, habitual robotic urticaria, eosinophilic esophagitis, eosinophilic gastritis/ eosinophilic gastroenteritis, eosinophilic granulomatosis with polyangiitis, hypereosinophilic pattern andnon-cystic fibrosis bronchiectasis.
AstraZeneca in Respiratory and Immunology
Respiratory & Immunology, part of BioPharmaceuticals, is one of AstraZeneca’s main complaint areas and is a crucial growth motorist for the Company.
AstraZeneca is an established leader in respiratory care with a 50- time heritage. The Company aims to transfigure the treatment of asthma and COPD by fastening on earlier biology- led treatment, barring preventable asthma attacks, and removing COPD as a top- three leading cause of death. The Company’s early respiratory exploration is concentrated on arising wisdom involving vulnerable mechanisms, lung damage and abnormal cell- form processes in complaint and neuronal dysfunction.
With common pathways and underpinning complaint motorists across respiratory and immunology, AstraZeneca is following the wisdom from habitual lung conditions to immunology- driven complaint areas. The Company’s growing presence in immunology is concentrated on five medial- to late- stage votes withmulti-disease eventuality, in areas including rheumatology( including systemic lupus erythematosus), dermatology, gastroenterology, and systemic eosinophilic- driven conditions. AstraZeneca’s ambition in Respiratory & Immunology is to achieve complaint revision and durable absolution for millions of cases worldwide.
AstraZeneca( LSE/ STO/ Nasdaq AZN) is a global, wisdom- led biopharmaceutical company that focuses on the discovery, development, and commercialisation of tradition drugs in Oncology, Rare conditions, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Grounded in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative drugs are used by millions of cases worldwide.
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