AstraZeneca (AZ) has started late-stage trials of benralizumab as a treatment for patients with severe, uncontrolled asthma.
The drug – originally developed by AZ’s Medimmune unit – is an antibody targeting the interleukin-5 receptor and is thought to work by depleting the body of eosinophils, a type of white blood cell linked to the respiratory attacks that characterise asthma.
While many patients with milder forms of asthma respond to drugs like corticosteroids and beta agonists, around 20 per cent find they cannot fully control symptoms with these medicines, and a proportion of these have a critical need for alternative therapies to prevent life-threatening attacks.
A phase IIb trial of benralizumab has already been completed and showed that the antibody was able to cut exacerbation rates compared to placebo, said AZ. Results from the study are due to be presented at a conference next year.
AZ’s phase III programme for benralizumab is called Windward and is kicking off with the CALIMA study, which will see if the antibody can reduce the number of asthma exacerbations in patients who experience breakthrough attacks despite being on high doses of steroids and bronchodilators.
The study will also assess the effect of subcutaneously-administered benralizumab on lung function, asthma symptoms and other asthma control measures, as well as emergency room and hospitalisation rates, with patients enrolled on the basis of a blood test for eosinophil levels.
Two other studies – called SIROCCO and PAMPERO – will also look at treatment with the drug on top of high- and medium-dose corticosteroids, respectively, while AZ will also conduct a study called ZONDA to see if asthma patients can reduce steroid dosing whilst on the drug. Finally, a long-term study called BORA will examine its long-term safety.
“The development of benralizumab underscores our commitment to addressing and ultimately changing the course of chronic respiratory diseases through targeted and personalised treatment,” commented AZ’s William Mezzanotte, who heads the company’s respiratory/inflammation and neuroscience development units.
Benralizumab – which was originally licensed from Japanese company BioWa – is in the same drug class as Teva’s Cinquil (reslizumab) and GlaxoSmithKline’s mepolizumab, which are both already in phase III testing with results expected in 2014.
It is also targeting the same type of asthma patients as Sanofi and Regeneron Pharmaceuticals’ dupilumab, which is just starting a late-stage trial but targets IL-4 and IL-13 receptors rather than IL-5.