AstraZeneca asthma therapy tralokinumab flops at Phase 3
AstraZeneca and MedImmune, the company’s global biologics research and development arm, have announced new Phase 3 data revealing that tralokinumab failed to meet its primary endpoints in the treatment of asthma.
The findings were generated from two Phase 3 trials: STATOS 2 and TROPOS. In STRATOS 2, the anti-interleukin-13 (IL-13) human monoclonal antibody failed to achieve a statistically significant reduction in annual asthma exacerbation rate (AAER) compared to placebo in patients with severe, uncontrolled forms of the disease along with elevated levels of Fractional exhaled Nitric Oxide (FeNO), a biomarker for airway inflammation.
Meanwhile, in the TROPOS study the drug also missed its endpoint in generating a statistically significant reduction in oral corticosteroid use when added to standard of care in patients dependent on them.
“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,” commented Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca.
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