AstraZeneca's experimental drug tralokinumab misses main goal of late-stage asthma trial

AstraZeneca said Wednesday that the experimental drug tralokinumab failed to meet the primary endpoint of a significant reduction in the annual asthma exacerbation rate (AAER) in the overall population of severe, uncontrolled asthma patients, compared with placebo in a Phase III study. The company noted that the STRATOS 1 trial is the first of two pivotal Phase III studies for the anti-IL-13 human monoclonal antibody.

The STRATOS 1 study was designed to evaluate the efficacy and safety of a regular, subcutaneous administration of tralokinumab for 52 weeks in adult and adolescent patients with severe asthma inadequately controlled despite treatment with an inhaled corticosteroid plus long-acting beta2-agonist. AstraZeneca noted that the trial explored the potential to use biomarkers to identify patients with an enhanced response to tralokinumab, while the second pivotal study, called STRATOS 2, is designed to validate the biomarker population identified in STRATOS 1.

According to the company, in the STRATOS 1 study, a "clinically-relevant" reduction in AAER was observed in a sub-population of patients with an elevated biomarker associated with increased IL-13 activity. AstraZeneca indicated that this sub-group of patients will now be the focus for the future analysis of STRATOS 2, which chief medical officer Sean Bohen noted will come "in the second half of 2017."

FirstWord reports in this therapy area - KOL Insight Targeted Therapies in Asthma: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.

Last year, Roche reported that a late-stage study of the experimental therapy lebrikizumab, which blocks the action of IL-13, in people with severe asthma met its primary endpoint, although an identical trial failed to meet the same main goal. For related analysis, read ViewPoints: Following AstraZeneca's tralokinumab setback, are IL-13 inhibitors in the last chance saloon?

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