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AZ takes asthma antibody into phase III

Tralokinumab tipped as potential blockbuster
AstraZeneca AZ headquarters London UK

AstraZeneca (AZ) has continued a positive run of pipeline news by announcing the start of phase III trials of its anti-interleukin-13 (IL-13) drug tralokinumab in severe asthma.

Tralokinumab is another drug to emerge from the pipeline of AZ subsidiary Medimmune and will be targeted at asthma patients who struggle to control their symptoms despite current anti-inflammatory therapies such as corticosteroids.

It is one of a pair of new antibodies in the asthma category - along with anti-IL5 antibody benralizumab which started phase III trials last year - that were recently tipped by analyst Seamus Fernandez of Leerink Partners as having the potential to bring in $1.8bn in sales at peak.

IL-13 is thought to be intimately involved in the onset of asthma attacks, and elevated levels of the cytokine seem to tally with severe, frequent attacks and impaired lung function in asthma patients.

The tralokinumab phase III programme will see how effective the antibody is in reducing the rate of asthma exacerbations (AER) in adults and adolescents with severe asthma that is uncontrolled despite inhaled corticosteroid plus long-acting beta agonist (LABA) therapy.

It will also evaluate the drug's impact on lung function scores, patient-reported symptoms and quality of life, as well as try to identify biomarkers that could be used to target treatment with the antibody to the patients most likely to respond.

Phase II data with tralokinumab reported in May at the American Thoracic Society (ATS) conference in San Diego showed the drug achieved a significant reduction in AER as well as improvement in markers of asthma control when given every two weeks on top of background treatment with fluticasone and salmeterol.

"Patients with severe asthma currently have limited treatment options and need more effective therapies to control their disease," said Bill Mezzanotte, vice president of inflammation, neuroscience and respiratory drug development at AZ.

Other anti-IL-13 candidates in development as asthma treatments include Roche's lebrikizumab, which is already in phase III testing. Roche presented data at ATS indicating lebrikizumab was most effective in a specific sub-population of asthma patients with high levels of the biomarker protein periostin.

Pfizer was developing an anti-IL-13 candidate called anrukinzumab for asthma, but according to its latest pipeline report seems to have retreated from respiratory use and is focusing on developing the antibody for ulcerative colitis. It has reached phase II testing in that indication.

Article by
Phil Taylor

14th August 2014

From: Research

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