AstraZeneca says it is putting its investigational severe asthma drug tralokinumab into late-stage trials.
The decision to put the drug into Phase III is based on mid-stage data presented at American Thoracic Society conference in San Diego in May. The monoclonal antibody targets interleukin-13 (IL-13,a key cytokine believed to play a key role in the pathogenesis of asthma.
The late-stage study will evaluate tralokinumab in reducing the rate of asthma exacerbations in adults and adolescents with severe, inadequately controlled asthma despite receiving inhaled corticosteroids plus long-acting beta2-agonists. It will also assess lung function, patient-reported asthma symptoms and quality of life, as well as investigate whether potential clinical biomarkers could identify patients who are more likely to respond to tralokinumab.
Bill Mezzanotte, head of inflammation, neuroscience and respiratory at AstraZeneca, noted that patients with severe asthma currently have limited treatment options. He added that the development of tralokinumab “underscores our commitment to a personalised treatment approach for these patients [and] we are working to better understand patient subtypes, identify potential biomarkers, and tailor therapies”.
Tralokinumab is also being investigated in a Phase II study in patients with mild-to-moderate idiopathic pulmonary fibrosis.
