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Amgen/AstraZeneca's Asthma Drug Misses Phase III Study Goal

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Amgen, Inc. (AMGN - Free Report) and partner AstraZeneca (AZN - Free Report) announced that a phase III study (SOURCE) evaluating their pipeline candidate, tezepelumab in patients with severe, oral corticosteroid-dependent asthma did not meet the primary endpoint.

The primary endpoint of the study was to show a statistically significant reduction in the daily oral corticosteroid (OCS) dose without loss of asthma control on treatment with tezepelumab, an anti-thymic stromal lymphopoietin monoclonal antibody. The 48-week study, which compared tezepelumab to placebo, evaluated 150 severe asthma patients who required maintenance use of OCS on top of standard of care (SoC). The company said that other efficacy parameters and safety profile of tezepelumab in the SOURCE study were similar to previous studies including the phase III NAVIGATOR study, for which data was announced last month. Additional analysis of the data from the SOURCE study is ongoing and further data will be presented at a future medical conference.

The NAVIGATOR study on tezepelumab met the primary endpoint of a statistically significant and clinically meaningful reduction in annual asthma exacerbation rate (“AAER”), a measure of deterioration of asthma in a broad population of severe, uncontrolled asthma patients,  including those with low levels of eosinophils.

NAVIGATOR and SOURCE studies are part of phase III PATHFINDER clinical program on tezepelumab. Amgen and AstraZeneca plan to file regulatory applications for tezepelumab next year.

This year so far, AstraZeneca’s shares have declined 2.3% against an increase of 1.6% for the industry.

 

 

Amgen’s stock has declined 8.3% this year so far against an increase of 10.1% for the industry.

 

Amgen and AstraZeneca are jointly developing tezepelumab. They are equally sharing costs and will share profits in the same way. While AstraZeneca is responsible for clinical development, Amgen leads manufacturing efforts. In North America, Amgen and AstraZeneca will jointly commercialize tezepelumab, if approved. Outside the United States, Amgen will record sales as collaboration revenues.

The asthma market is quite crowded with currently FDA approved biologic therapies for treatment of severe asthma like Glaxo’s (GSK - Free Report) Nucala, AstraZeneca’s Fasenra and Sanofi/Regeneron’s (REGN - Free Report) Dupixent.

Both AstraZeneca and Amgen currently have a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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