The Phase III program will assess the safety and effectiveness of tralokinumab in reducing the rate of asthma exacerbations (AER) in adults and adolescents with severe, inadequately controlled asthma despite receiving inhaled corticosteroids plus long-acting ß2-agonist.
In the program, the effects of tralokinumab will also be assessed on lung function, patient-reported asthma symptoms and quality of life, and also investigate whether potential clinical biomarkers could identify patients who are more likely to respond to the drug.
Tralokinumab is an investigational human monoclonal antibody which potently and selectively neutralizes interleukin-13 (IL-13).
IL-13 is a key cytokine that is believed to contribute to the onset of severe and frequent asthma attacks, impaired lung function and other debilitating asthma symptoms by driving inflammation, airway hyper-responsiveness and excessive mucus production.
AstraZeneca Global Medicines Development unit vice-president and head of Inflammation, Neuroscience and Respiratory Bill Mezzanotte said the company is happy to begin the tralokinumab Phase III programme in severe asthma, further strengthening the breadth of its portfolio in respiratory disease, one of its core therapy areas.
"Patients with severe asthma currently have limited treatment options and need more effective therapies to control their disease," Mezzanotte said.
"The development of tralokinumab underscores our commitment to a personalised treatment approach for these patients, to improve their lives.
"Severe asthma is highly heterogeneous; we are working to better understand patient subtypes, identify potential biomarkers, and tailor therapies to cellular and molecular phenotypes to achieve the best clinical outcomes."
The company said that the start of the Phase III programme is based on results from a Phase IIb study conducted by MedImmune.
Image: AstraZeneca headquarters in London, UK. Photo: courtesy of AstraZeneca plc.