AstraZeneca (AZ) has teamed up with Abbott to develop a companion diagnostic for experimental asthma drug tralokinumab, currently in phase III testing.
To date there are no approved companion diagnostics for asthma therapies, according to AZ, which said the diagnostic would be able to identify patients most likely to respond to treatment with the drug.
Tralokinumab is an anti-interleukin-13 (IL-13) antibody – originally developed by AZ’s Medimmune unit – that entered phase III testing last summer for patients with severe asthma that is inadequately controlled using corticosteroids and long-acting beta agonists.
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.
Abbott will develop a kit that will measure serum levels of the proteins periostin and DPP4, which are thought to be biomarkers that reveal when IL-13 activity has increased in patients with severe asthma.
The tests will be used in AZ’s phase III trials programme and so could be approved alongside tralokinumab if successful.
The latest deal is one of a pair of collaborations just announced by AZ, sitting alongside an agreement with the Montreal Heart Institute (MIH) that will try to find biomarkers for cardiovascular diseases and diabetes.
Bing Yao, head of the respiratory, inflammation and autoimmunity innovative medicines unit at MedImmune, said “we anticipate that physicians will ultimately use these tests to better identify patients likely to benefit most from tralokinumab to bring their condition under control.”
He added: “we are on the cusp of a new era in personalised healthcare, one which will see great improvements for patients treated with respiratory medicines.”
Tralokinumab is one of several new drugs targeting IL subtypes that are coming through the pipeline for asthma and promise to provide another line of therapy for patients who cannot control symptoms using current treatments.
The use of diagnostics to select patients most likely to benefit from therapy could potentially mean these drugs become first-line candidates in some cases.
Other pipeline candidates include AZ’s IL-5 antagonist benralizumab which is in the latter stages of development. GlaxoSmithKline (GSK) is currently leading the IL-5 pack with its mepolizumab product – filed in Europe last November – while Teva has a candidate called reslizumab due for filing this year.
Regeneron and Sanofi have a dual IL-4 and IL-13 blocker called dupilumab in phase III, while AZ’s IL-17-targeting brodalumab is scheduled to be filed for psoriasis later this year and is in a phase II study in inadequately controlled severe asthma.