AstraZeneca and Amgen have announced positive topline results from the Phase III WAYPOINT trial of Tezspire (tezepelumab) in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The study achieved its co-primary endpoints, demonstrating a significant reduction in nasal polyp size and nasal congestion compared to placebo.
The companies stated that detailed results from the trial will be shared with regulatory authorities and the scientific community at an upcoming medical meeting. The WAYPOINT study (NCT04851964) enrolled 416 patients with severe CRSwNP. The co-primary endpoints were the change from baseline at 52 weeks in total nasal polyp size, measured by the endoscopic total Nasal Polyp Score, and the change from baseline in bi-weekly mean nasal congestion, measured by the participant-reported Nasal Congestion Score.
Clinical Significance of Tezspire in CRSwNP
Chronic rhinosinusitis with nasal polyps is a chronic inflammatory disease of the upper airways characterized by persistent inflammation of the sinuses and the presence of nasal polyps. This condition leads to symptoms such as nasal congestion, facial pain, and a reduced sense of smell, significantly impacting patients' quality of life. Current treatments often include corticosteroids and surgery, but many patients require additional therapies to manage their symptoms effectively.
Tezspire's success in the WAYPOINT trial offers a promising new treatment option for these patients. By targeting thymic stromal lymphopoietin (TSLP), a key driver of inflammation, Tezspire addresses the underlying pathophysiology of CRSwNP. The drug's ability to reduce both polyp size and nasal congestion suggests a comprehensive approach to managing the disease.
Tezspire's Mechanism and Market Context
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 initially approved by the FDA as a treatment for severe asthma in 2021.
Tezspire's main competitor in the CRSwNP space is Sanofi and Regeneron’s Dupixent (dupilumab), which is already approved for CRSwNP and other immune-mediated disorders. Dupixent recorded €10.7 billion ($11.6 billion) in global sales last year, while Tezspire generated $86 million. GlobalData forecasts revenues of $20.4 billion and $3.6 billion in 2030 for Dupixent and Tezspire, respectively.
Further Development of Tezspire
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.
