AZ's tralokinumab misses in Phase III asthma trial

AstraZeneca plc (LSE:AZN; NYSE:AZN) said 300 mg tralokinumab (CAT-354) every 2 weeks missed the primary endpoint of reducing annual asthma exacerbation rate in the overall population vs. placebo in the Phase III STRATOS 1 trial in about 2,247 patients with severe uncontrolled asthma. Tralokinumab is a human IgG4 mAb against IL-13.

In a subpopulation of patients with an elevated biomarker associated with increased IL-13 activity, tralokinumab led to a "clinically relevant" reduction in annual asthma exacerbation rate. AZ said it is "premature" to disclose the biomarker identified in the subgroup. The company said this subgroup will now be the focus of its analysis for the ongoing Phase III STRATOS 2 trial of tralokinumab. Data from STRATOS 2 are expected next half...