AstraZeneca and Amgen's Tezspire has met both primary endpoints in the WAYPOINT Phase III clinical trial.
The drug can be administered subcutaneously, and is suitable for use in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
During the study, it was found that Tezspire could significantly reduce the size of nasal polyps and diminish congestion when compared to placebo.
The randomised, double-blind trial evaluated both the efficacy and safety of Tezspire in adults with severe CRSwNP, who were all symptomatic despite receiving intranasal corticosteroids.
During the trial period, the injectable also exhibited a similar safety and tolerability profile to previous findings.
AstraZeneca has stated that full results will be shared with regulatory authorities in due course.
Dr Joseph Han, Vice Chair of Rhinology & Endoscopic Sinus and Skull Base Surgery, and Allergy, Otolaryngology-Head and Neck Surgery, Eastern Virginia Medical School, US, and co-primary investigator in the trial, said: “Chronic rhinosinusitis with nasal polyps negatively impact 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.”
Sharon Barr, Executive Vice President, BioPharmaceuticals R&D said: “We are excited by the positive results from the Phase III WAYPOINT trial, which show that patients with nasal polyps strongly benefitted from treatment with tezepelumab."
"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.”
Dr Brian Lipworth, Professor of Allergy and Pulmonology, Scottish Centre for Respiratory Research, and Tayside Rhinology Ear, Nose and Throat Clinic, Ninewells Hospital University of Dundee in Scotland, UK, and co-primary investigator in the trial, concluded: “Patients diagnosed with nasal polyps continue to experience significant burden including repeat surgeries and frequent treatment with high doses of oral corticosteroids, which are associated with serious systemic side effects. The tezepelumab data are clinically meaningful and offer patients with nasal polyps hope for a potential new treatment option that may reduce the burden on patients and healthcare systems.”
Tezspire is currently approved for the treatment of severe asthma in the US, EU, Japan, and nearly 60 countries across the globe.2-5 It is approved as a single-use pre-filled syringe and auto-injector for self-administration in the US and EU.