AstraZeneca plc (ADR) (NYSE:AZN) shares could come under pressure on Wednesday after the company indicated that its Tralokinumab failed to meet primary endpoint of a significant reduction in asthma exacerbation rate. The company indicated that its pivotal third stage trial on STRATOS 2 is proceeding and the results could be expected in the second half of the current year.
In a SEC filing, AstraZeneca indicated that Tralokinumab was compared with placebo in STRATOS 1, which is the first of two pivotal third stage studies. The trial was in respect of annual asthma exacerbation rate (AAER) in the overall population of severe and uncontrolled asthma patients in comparison with placebo. The company revealed that a clinically-important reduction in AAER was noticed in a sub-population of patients, who have an elevated biomarker associated with higher IL-13 activity.
The British firm indicated that it would focus on this sub-group of patients for the future analysis of STRATOS 2, which is the second pivotal third stage study. During the trial, the safety and tolerability were consistent with those assessed in earlier studies with tralokinumab. The company revealed that a complete data evaluation is being conducted and that the results would be presented during an upcoming medical meeting.
AstraZeneca’s EVP for global medicines deployment and chief medical officer, Sean Bohen, commented, “Severe asthma is a heterogeneous disease with significant unmet needs and we will now await the STRATOS 2 results in the second half of 2017 to explore the potential to treat a sub-group of uncontrolled asthma patients with tralokinumab.”
Following the latest results from the study, the company indicated that any future regulatory submissions in respect of tralokinumab would be based on the combined analysis of both STRATOS 1 and STRATOS 2. These are the two privotal studies in the ATMOSPHERE clinical program.
AstraZeneca revealed that Asthma affects as many as 315 million individuals throughout the world. Significantly, ten percent of asthma patients were suffering from severe asthma that might be uncontrolled despite higher doses of standard care asthma medicines. This set of patients required the chronic oral corticosteroids use.
On Tuesday, the stock closed the normal trading session with a gain of 2.22 percent. The stock could come under pressure after the negative news on Wednesday.