Tralokinumab fails in STRATOS 2 and TROPOS trials for severe asthma.-AstraZeneca

AstraZeneca and its global biologics research and development arm, MedImmune,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.

In 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. In 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. FeNO 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. The safety and tolerability findings in STRATOS 2 and TROPOS were consistent with those observed in previous trials with tralokinumab.

Comment:These setbacks come several months after the interleukin-13 inhibitor failed the STRATOS 1 study in May 2017.