AstraZeneca has signed an agreement with Abbott to develop companion diagnostic tests for identification of patients with severe asthma who may benefit from the investigational biological therapy, tralokinumab.
Under the agreement, Abbott will develop and commercialise diagnostic tests to measure serum levels of the proteins periostin and dipeptidyl peptidase-4 (DPP4) that have been identified as potential predictive biomarkers of up-regulated IL-13 in severe asthma.
Tests are scheduled to be developed in accordance with AstraZeneca's Phase III trial of tralokinumab, a potential treatment developed by the company's biologics research and development unit, MedImmune, for patients with severe, inadequately controlled asthma.
No companion diagnostic blood tests have so far been approved for use in asthma.
MedImmune Respiratory, Inflammation and Autoimmunity Innovative Medicines Unit senior vice-president Bing Yao 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."
The tralokinumab Phase III programme aims to validate the safety and effectiveness of the therapy in lowering the rate of asthma exacerbations in adults and adolescents with severe, inadequately controlled asthma, despite receiving inhaled corticosteroids and long-acting ß2-agonist.
In addition to evaluating the effect of tralokinumab on lung function, patient-reported asthma symptoms and quality of life, the programme will investigate whether serum periostin or DPP4 could identify patients who are most likely to benefit from the therapy.
A chronic inflammatory disorder of the airways characterised by reversible narrowing of the bronchi, asthma affects people of all ages and is a claimed to be a significant source of morbidity and mortality worldwide.
Image: Obstruction of the lumen of the bronchiole by mucoid exudate, goblet cell metaplasia, epithelial basement membrane thickening and severe inflammation of bronchiole. Photo: courtesy of Yale Rosen.