The Phase III trial of tralokinumab, a drug developed by AstraZeneca plc (ADR) (NYSE:AZN) for patients suffering from uncontrolled and severe asthma, has failed to reach its primary endpoint. When compared to placebo, tralokinumab did not manage to reduce the level of the asthma exacerbation rate. The drug had already experienced problems at Roche.
In the study over 1000 adolescents and adults suffering from asthma participated. Through random selection, some of the participants received either a placebo while others got tralokinumab once every two weeks for a period of 52 weeks. During that period the change in the rate of asthma exacerbation in patients was assessed and it was determined that the asthma drug was unable to perform better than placebo.
Clinically relevant
As a result of the setback AstraZeneca sought to analyze a patient subpopulation where a clinically relevant set of results were obtained. This will now be the focus of another Phase III trial. The results of this trial are expected to be out this year.
The results were, however, not surprising since Roche had already reported results which were disappointing with lebrikizumab, a drug that is similar to tralokinumab, in 2016. Both drugs work by blocking a protein known as interleukin-13.
Tralokinumba is, however, not the only drug by AstraZeneca for treating patients with severe asthma as there is another experimental drug known as benralizumab that functions a little bit differently and is now waiting for approval from the U.S. Food and Drug Administration. If benralizumab gets the approval of the FDA, it will be in competition with Nucala that has been developed by GlaxoSmithKline plc (ADR) (NYSE:GSK) and which was recently approved.
Global rate
Globally the number of people suffering from Asthma is about 315 million. Of these about 10% suffer from severe asthma. Even in cases where standard asthma controller medicines are in use, severe asthma may continue uncontrolled. This can be debilitating as well as potentially fatal as it significantly limits lung function.
On Wednesday shares of AstraZeneca rose by 0.29% to close the day at $31.13.
