AstraZeneca & Abbott to develop companion diagnostic tests for tralokinumab in severe asthma

AstraZeneca today announced that it has entered an agreement with Abbott, a global healthcare company, to develop companion diagnostic tests to identify patients with severe asthma who are most likely to benefit from the investigational biological therapy, tralokinumab. To date, no companion diagnostic blood tests have been approved for use in asthma.

Under the terms of the agreement, Abbott will develop and commercialise diagnostic tests to measure serum levels of the proteins periostin and DPP4 (dipeptidyl peptidase-4), which have been identified as potential predictive biomarkers of up-regulated IL-13 in severe asthma. The tests will be developed in conjunction with AstraZeneca’s Phase III trial of tralokinumab, a potential treatment for patients with severe, inadequately controlled asthma, developed by the company’s biologics research and development arm, MedImmune. Periostin has been previously described as a potential biomarker for asthma1, and DPP4 is a novel and promising predictive biomarker identified by MedImmune.

The tralokinumab Phase III programme will evaluate the safety and effectiveness of tralokinumab in reducing the rate of asthma exacerbations in adults and adolescents with severe, inadequately controlled asthma despite receiving inhaled corticosteroids plus long-acting β2-agonist. The programme will also assess the effect of tralokinumab on lung function, patient-reported asthma symptoms and quality of life, as well as investigate whether serum periostin or DPP4 could identify patients who are most likely to benefit from tralokinumab.

Bing Yao, Senior Vice President and Head of MedImmune’s Respiratory, Inflammation and Autoimmunity Innovative Medicines Unit said: “This partnership with Abbott to develop companion diagnostics for tralokinumab is an important step in delivering on our ambition to bring innovative options for patients who continue to suffer with severe asthma. We anticipate that physicians will ultimately use these tests to better identify patients likely to benefit most from tralokinumab to bring their condition under control. We are on the cusp of a new era in personalised healthcare, one which will see great improvements for patients treated with respiratory medicines.”

Personalised healthcare is at the centre of AstraZeneca’s approach to drug discovery and development and this collaboration is part of the company’s strategy to seek external partners to develop companion diagnostics that will help transform patients’ lives.

1. Brightling CE, She D, Ranade K, et al. Efficacy and safety of tralokinumab, an anti-il-13 monoclonal antibody, in a phase 2b study of uncontrolled severe asthma. Poster presented at the American Thoracic Society Congress, San Diego, May 16-21 2014.

About Asthma

Asthma is a chronic inflammatory disorder of the airways in which the bronchi are reversibly narrowed. It affects people of all ages and is a significant source of morbidity and mortality worldwide. Asthma can be allergic (induced by an immune response to inhaled allergens such as pollen, fungal spores or dust mite particles) or non-allergic (induced by exercise, cough, viral respiratory infection, or inhalation of smoke or chemicals in the workplace). The airway narrowing characteristic of asthma is a response of the immune system to the asthma trigger.

Severe persistent asthma is classified by the frequency of symptoms throughout the day and night, use of reliever inhalers, interference with daily activities, peak flow readings and whether asthma exacerbations require use of oral systemic corticosteroids more than twice a year. Asthma treatment usually includes inhaled corticosteroids that reduce inflammation of the airways to prevent asthma symptoms and exacerbations, combined with long-acting β2-agonist bronchodilators and a short-acting β2-agonist or other bronchodilator for relief.

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