An experimental drug being tested as a treatment for severe asthma by pharmaceutical company AstraZeneca has failed to meet its primary endpoint of significantly reducing the annual rate of asthma exacerbations in the first of two phase III studies, the company has announced.
The drug, tralokinumab, is an anti-interleukin-13 human monoclonal antibody, which blocks the interleukin-13 (IL-13) protein.
The trial, STRATOS 1, evaluated the efficacy and safety of tralokinumab in reducing the rate of asthma exacerbations in adults and adolescents with severe asthma, inadequately controlled despite receiving inhaled corticosteroids plus long-acting beta2-agonist.
While a clinically relevant reduction in asthma exacerbations was not observed in asthma patients overall, a reduction in exacerbations was seen in a sub-population of patients. This sub-group of patients had an elevated biomarker associated with increased IL-13 activity and will now be the focus for the future analysis of the second trial, STRATOS 2, results of which are expected later in 2017.
Sean Bohen, executive vice president, global medicines development and chief medical officer at AstraZeneca, says: “Severe asthma is a heterogeneous disease with significant unmet needs and we will now await the STRATOS 2 results in the second half of 2017 to explore the potential to treat a sub-group of uncontrolled asthma patients with tralokinumab.”
A drug being developed by competitor company Roche called lebrikizumab, which blocks the same IL-13 protein, also produced disappointing phase III trial results last year.