AstraZeneca (AZ) and Amgen have shared positive results from a late-stage study of Tezspire (tezepelumab) in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
The phase 3 WAYPOINT trial has been evaluating the drug, administered subcutaneously, in adults with severe cases of the complex inflammatory disorder who were symptomatic despite treatment with standard-of-care intranasal corticosteroids.
Tezspire met both of the trial’s co-primary endpoints, demonstrating a statistically significant and clinically meaningful reduction in the size of nasal polyps and reduced nasal congestion compared to placebo.
The safety profile and tolerability of the drug were also shown to be consistent with its known profile.
CRSwNP is a chronic disease characterised by persistent inflammation of the nasal mucosa accompanied by benign growths, called nasal polyps. Patients can experience a variety of symptoms, including breathing problems, reduced sense of smell, nasal discharge, facial pain, sleep disturbance and other adverse effects on quality of life.
WAYPOINT co-primary investigator Brian Lipworth, Ninewells Hospital University of Dundee, explained: “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 [Tezspire] data is clinically meaningful and offers patients with nasal polyps hope for a potential new treatment option that may reduce the burden on patients and healthcare systems.”
Tezspire is designed to inhibit the action of TSLP, shown to play a key role in allergic, eosinophilic and other types of endothelial inflammation associated with severe asthma and other inflammatory diseases.
The drug is already approved in the US, EU and almost 60 countries as an add-on maintenance treatment for severe asthma patients aged 12 years and older.
Sharon Barr, executive vice president, biopharmaceuticals research and development, AZ, said: “These results reinforce that [Tezspire’s]… mode of action, targeting TSLP at the top of the inflammatory cascade, effectively addresses the multiple drivers of epithelial-driven inflammatory diseases.”
The partners outlined that full results from WAYPOINT will be shared with regulatory authorities and presented at an upcoming medical meeting.