AstraZeneca has entered an agreement with Abbott 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, according to AstraZeneca.

Under the terms of the agreement, Abbott will develop and commercialize 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 promising predictive biomarker identified by MedImmune.

The tralokinumab Phase III program 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 program 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.

Source: AstraZeneca