Company: AZN
Filing Date: 2025-09-22
Form Type: 6-K
Source: 0001654954-25-010967
Chunk: 3

Company: ASTRAZENECA PLC
Filing Date: 2025-09-22
Form: 6-K
Chunk 3
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 Polyp Score, and 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. 2 ,20 Key secondary endpoints included loss of smell; improvement in disease specific health-related quality of life as measured by SinoNasal Outcome Test (SNOT-22) score; Lund-Mackay score; time to surgery decision and/or systemic corticosteroids for nasal polyposis; time to nasal polyposis surgery decision; time to systemic corticosteroids for nasal polyposis; Nasal Polyposis Symptom Diary total symptom score and, in the population with co-morbid asthma, pre-bronchodilator FEV1 at Week 52. 2, 20

Tezepelumab

Tezepelumab is being developed by AstraZeneca in collaboration with Amgen as a first-in-class human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), a key epithelial cytokine that sits at the top of multiple inflammatory cascades and is critical in the initiation and persistence of allergic, eosinophilic and other types of epithelial inflammation associated with severe asthma, CRSwNP and other inflammatory diseases. 12,13

TSLP is released by the epithelium in response to environmental triggers (including allergens, viruses and other airborne particles) associated with asthma, CRSwNP, chronic obstructive pulmonary disease (COPD), eosinophilic esophagitis (EoE) and other diseases. 13 Across these disease states, the expression of TSLP is increased and correlates with disease severity. 7,12

Tezspire is approved as a single-use pre-filled syringe and auto-injector for self-administration in the US and EU. 9-11 Since 2021, over 100,000 patients have been treated with Tezspire for severe asthma. 21

Beyond CRSwNP, Tezspire is also being explored in Phase III trials in COPD and EoE. 22,23 In October 2021, Tezspire was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of EoE.

Amgen Collaboration

The 2012 Collaboration Agreement between Amgen and AstraZeneca