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Amgen and AstraZeneca’s brand of tezepelumab (Tezspire®) has shown efficacy in reducing both nasal congestion and nasal polyp size in patients with chronic rhinosinusitis with nasal polyps.

About the drug

Tezepelumab is a first-in-class human monoclonal antibody that works by inhibiting activity of thymic stromal lymphopoietin (TSLP), thereby preventing the release of pro-inflammatory cytokines, which in turn results in reduced epithelial inflammation.

The biologic, developed through an Amgen and AstraZeneca collaboration, is approved in both Europe and the U.S. as an adjunct maintenance therapy in the management of severe asthma.

Now, it may be on course for licensing in the treatment of chronic rhinosinusitis with nasal polyps.

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About the chronic rhinosinusitis

Chronic rhinosinusitis is characterized by continuous inflammation of the nasal mucosa together with nasal polyps—benign growths on the epithelium. These growths may lead to symptoms including sleep apnea, difficulty breathing, facial pain, and nasal discharge.

Surgery, corticosteroids, and biologics are the current preferred treatment interventions.

About the trial

The study coded WAYPOINT is a phase III clinical trial that recruited adults with chronic rhinosinusitis with nasal polyps who randomly received either tezepelumab or placebo. The two primary endpoints of the study were change from baseline in total nasal polyp size and change from baseline in biweekly mean nasal congestion. Tezepelumab showed a statistically significant and clinically meaningful decrease in nasal polyp size and a decrease in nasal congestion compared to placebo.

What was said

“Chronic rhinosinusitis with nasal polyps negatively impacts patients’ daily lives with obstructions leading to disturbances in smell, taste, and sleep, as well as pain and fatigue. The impressive data from the Waypoint trial demonstrate tezepelumab’s potential as a new treatment for patients whose lives are disrupted by this debilitating disease,” stated Dr. Joseph Han, co-primary investigator, Waypoint.

“These results reinforce that tezepelumab’s first-in-class mode of action, targeting TSLP at the top of the inflammatory cascade, effectively addresses the multiple drivers of epithelial-driven inflammatory diseases.”

 

Sharon Barr, Executive Vice President, AstraZeneca.

Conclusion

AstraZeneca plans to share the positive results with the relevant regulatory authorities as well as the scientific community in an upcoming medical meeting.

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