AstraZeneca and its global biologics research and development arm, MedImmune, have announced disappointing results from phase III trials of tralokinumab in severe, uncontrolled asthma.
AZ said that in STRATOS 2 trial, tralokinumab did not achieve a statistically-significant reduction in the annual asthma exacerbation rate (AAER), the primary endpoint, in patients with severe, uncontrolled asthma and elevated levels of a biomarker, Fractional exhaled Nitric Oxide (FeNO), compared to placebo. It said that in the TROPOS trial, tralokinumab did not achieve a statistically-significant reduction in oral corticosteroid (OCS) use, the primary endpoint, when added to the standard of care, in patients dependent on OCS.
Executive vice-president, global medicines development and chief medical officer, Sean Bohen, said: 'The results are disappointing as we had hoped that tralokinumab would benefit patients with severe asthma, which is a complex disease with limited treatment options today.'
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