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AstraZeneca, Amgen Report Positive Results From Tezepelumab Trial In Severe Asthma

British drug major AstraZeneca Plc. (AZN.L,AZN) and Amgen Inc. (AMGN) announced Tuesday positive results from the NAVIGATOR Phase III trial for the potential new medicine tezepelumab in patients with severe, uncontrolled asthma.

The trial met primary endpoint of a statistically significant and clinically meaningful reduction in exacerbations in a broad population of patients with severe asthma. The trial also met the primary endpoint in patients with low levels of eosinophils.

Tezepelumab is a potential first-in-class medicine that blocks the action of thymic stromal lymphopoietin or TSLP, an epithelial cytokine that plays a key role across the spectrum of asthma inflammation.

NAVIGATOR is the first Phase III trial to show benefit in severe asthma by targeting TSLP.

The company noted that Tezepelumab was very well tolerated in patients with severe asthma. Preliminary analyses show no clinically meaningful differences in safety results between the tezepelumab and placebo groups.

Results from the NAVIGATOR trial will be presented at a forthcoming medical meeting.

Patients who participated in the NAVIGATOR and SOURCE trials were eligible to continue in DESTINATION, a Phase III extension trial assessing long term safety and efficacy.

Earlier in 2020, Amgen and AstraZeneca updated the 2012 collaboration agreement for tezepelumab. Both companies will continue to share costs and profits equally after payment by AstraZeneca of a mid single-digit royalty to Amgen.

Under the amended agreement in North America, Amgen and AstraZeneca will jointly commercialise tezepelumab; Amgen will record sales in the US and AstraZeneca will record sales in Canada.

In London, AZN shares were trading at 8,401 pence, up 1.20 percent.

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