Business
AstraZeneca tralokinumab update in severe asthma
AstraZeneca tralokinumab update in severe asthma.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 1834V AstraZeneca PLC 01 November 2017 \n\nThis announcement contains inside information\n \n1 November 2017 07:00 GMT\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n \nASTRAZENECA PROVIDES UPDATE ON TRALOKINUMAB PHASE III PROGRAMME IN SEVERE, UNCONTROLLED ASTHMA\n \nAstraZeneca and its global biologics research and development arm, MedImmune, today announced the top-line results of the Phase III STRATOS 2 and TROPOS trials for tralokinumab, an anti-interleukin-13 (IL-13) human monoclonal antibody, in severe, uncontrolled asthma.\n \nIn STRATOS 2, 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.\n \nIn TROPOS, 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.\n \nSean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, 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.\" \n \nFeNO is a well-established biomarker for airway inflammation and was identified in the previous pivotal trial (STRATOS 1) as most likely to predict an enhanced response to tralokinumab. \n \nThe safety and tolerability findings in STRATOS 2 and TROPOS were consistent with those observed in previous trials with tralokinumab.\n \nFull data from STRATOS 1, STRATOS 2 and TROPOS will be presented at a forthcoming medical meeting.\n \nAbout Severe Asthma\nAsthma affects 315 million individuals worldwide, and up to 10% of asthma patients have severe asthma, which may be uncontrolled despite high doses of standard-of-care asthma controller medicines and can require the use of chronic OCS.\n \nSevere, uncontrolled asthma is debilitating and potentially fatal with patients experiencing frequent exacerbations and significant limitations on lung function and quality of life. \n \nSevere, uncontrolled asthma can lead to a dependence on OCS, with systemic steroid exposure potentia...