AstraZeneca's tezepelumab fails to meet primary endpoint in Phase III trials

Pharmaceutical giant AstraZeneca revealed on Tuesday that it had received some disappointing high-level results from Phase III SOURCE trials aimed at assessing the efficacy and safety of potential new medicine tezepelumab.

AstraZeneca stated a 48-week trial on tezepelumab, undertaken in conjunction with US biotechnology outfit Amgen, did not meet the primary endpoint of a "statistically significant" reduction in the daily oral corticosteroids dose for severe asthma patients, without loss of asthma control.

However, the FTSE 100-listed firm did note that tezepelumab's effect on other efficacy parameters was similar to those observed in previous trials, including the registrational Phase III NAVIGATOR trial.

AstraZeneca's 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."

As of 0810 GMT, AstraZeneca shares were down 1.21% at 7,350.0p.