Tezspire is a thymic stromal lymphopoietin (TSLP) inhibiting monoclonal antibody, which generated $86m in sales in 2023. Image credit: eamesBot / Shutterstock.

AstraZeneca and Amgen have released topline data from a Phase III trial of its inflammatory therapy, Tezspire (tezepelumab) in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).

The therapy met the co-primary endpoint of the WAYPOINT study (NCT04851964) by demonstrating “a statistically significant and clinically meaningful reduction in the size of nasal polyps and reduced nasal congestion compared to placebo”. The companies did not disclose detailed results from the trial, noting that these “will be shared with regulatory authorities and the scientific community at an upcoming medical meeting”.

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The study enrolled 416 patients with severe CRSwNP. The trial’s co-primary endpoints were a change from baseline at 52 weeks in total nasal polyp size, measured by the endoscopic total Nasal Polyp Score, and a change from baseline in bi-weekly mean nasal congestion, measured by the participant-reported Nasal Congestion Score evaluated as part of the daily Nasal Polyposis Symptom Diary.

The news follows mixed Phase IIb data for Tezspire in chronic obstructive pulmonary disease (COPD). The therapy failed to meet the primary endpoint of the placebo-controlled Phase IIa COURSE trial (NCT04039113). However, in a pre-determined subgroup analysis of COPD patients based on the levels of eosinophils, Tezspire showed a 48% reduction in severe exacerbations compared to the placebo.

The US Food and Drug Administration (FDA) also found the subgroup results significant and awarded Tezspire a breakthrough therapy designation as an add-on maintenance treatment for patients with moderate to very severe COPD characterised by an eosinophilic phenotype, in July.

Tezspire is a thymic stromal lymphopoietin (TSLP) inhibiting monoclonal antibody. TSLP is an interleukin (IL)-2-like cytokine, alarmin, and growth factor that plays a key role in the immune system. It was approved by the FDA as a treatment for severe asthma in 2021.

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The therapy’s main competitor in the space is Sanofi and Regeneron’s Dupixent (dupilumab). It has been approved to treat CRSwCP and multiple immune-mediated disorders, including asthma and COPD. In September, the companies received FDA approval to expand Dupixent’s label to include adolescents aged 12 to 17 years.

According to Sanofi’s financials, Dupixent pulled in €10.7bn ($11.6bn) in global sales last year. While Tezspire raked in $86m in global sales last year, per AstraZeneca’s financial statements. GlobalData forecasts both therapies’ revenue to maintain its upward trajectory and generate $20.4bn and $3.6bn in sales in 2030, respectively.

GlobalData is the parent company of Clinical Trials Arena.

Amgen and AstraZeneca are also investigating Tezspire in other conditions such as chronic spontaneous urticaria and eosinophilic esophagitis (EoE). In 2021, Tezspire received orphan drug designation from the FDA for the treatment of EoE.