AstraZeneca and Amgen have announced that the SOURCE Phase III trial of tezepelumab in severe asthma patients did not meet the primary endpoint.
The trial of tezepelumab was conducted in severe asthma patients who needed maintenance use of oral corticosteroids (OCS) on top of standard of care (SoC).
Being developed by AstraZeneca along with Amgen, tezepelumab is a potential human monoclonal antibody that hinders the action of thymic stromal lymphopoietin (TSLP).
Data showed that the 48-week trial failed to meet the primary endpoint of a statistically significant reduction in the daily OCS dose, without loss of asthma control, with tezepelumab versus placebo.
The supportive SOURCE trial is part of the PATHFINDER Phase III programme which also includes the registrational NAVIGATOR trial.
The multicentre, randomised, double-blinded, parallel-group, placebo-controlled SOURCE Phase III trial evaluated the efficacy and safety of the potential new medicine compared to placebo on 150 patients.
Tezepelumab 210mg was given to subjects every four weeks or placebo as add-on therapy, while they maintained on their inhaled corticosteroids (ICS) plus long-acting beta2-agonists (LABA), with or without other asthma controller therapy.
AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “Based on the totality of evidence, including the compelling exacerbation reduction results seen in the registrational NAVIGATOR Phase III trial and the PATHWAY Phase IIb trial, we remain confident that tezepelumab has the potential to improve care for a broad population of severe asthma patients.
“Our initial analysis of SOURCE in oral corticosteroid-dependent asthma indicates that the trial design may have contributed to the result of the primary endpoint.
“We are in the process of further analysing the data from SOURCE and look forward to sharing these results with the medical community.”
Tezepelumab’s safety profile in the trial was similar to previously observed ones.
Detailed results from the SOURCE trial will be presented soon.
Last month, AstraZeneca and Amgen reported positive results from the NAVIGATOR Phase III trial for tezepelumab, a potential drug in treating patients with severe, uncontrolled asthma.