AstraZeneca and Amgen announced positive topline results from a Phase 3 study of Tezspire (tezepelumab) in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
The Phase 3 WAYPOINT clinical trial was designed to evaluate the efficacy and safety of Tezspire in adults with severe CRSwNP, compared to placebo.
In the study, Tezspire showed a statistically significant and clinically meaningful reduction in the size of nasal polyps and reduced nasal congestion compared to placebo.
Also, the drug met both co-primary endpoints, with a safety and tolerability profile that was consistent with the known profile of the medicine.
The co-primary endpoints include a change in total nasal polyp size from baseline and a change in bi-weekly mean nasal congestion from baseline.
The nasal polyp size was measured by the endoscopic total Nasal Polyp Score, and nasal congestion by the participant-reported Nasal Congestion Score.
WAYPOINT trial co-primary investigator Joseph Han said: “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.”
WAYPOINT trial co-primary investigator Brian Lipworth said: “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 a human monoclonal antibody that works on the airway epithelium, which is the first point of contact for viruses, allergens, and pollutants, among others.
The drug works by inhibiting the action of TSLP, an epithelial cytokine that plays a key role in allergic, eosinophilic, and other types of endothelial inflammation.
TSLP is released in response to triggers such as allergens, viruses, and other airborne particles, and increased expression of TSLP is correlated with disease severity.
In 2020, Amgen and AstraZeneca updated a 2012 collaboration agreement for Tezspire.
Under the expanded collaboration, both companies will share costs and profits equally, excluding an inventor royalty paid by AstraZeneca to Amgen.
Tezspire is currently approved in the US, EU, Japan, and around 60 other countries worldwide, for the treatment of severe asthma in patients aged 12 years and above.
AstraZeneca BioPharmaceuticals R&D executive vice president Sharon Barr said: “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.”
Amgen chief scientific officer and research and development executive vice president Jay Bradner said: “The top-line results from our Phase 3 WAYPOINT study represent a significant step forward in our commitment to enhancing the lives of those affected by chronic rhinosinusitis with nasal polyps.
“The data highlight tezepelumab’s unique capacity to target multiple inflammatory pathways by acting directly at the epithelium, resulting in meaningful symptom relief that can improve patients’ daily experiences.”
