Tezspire by AstraZeneca and Amgen successful in Phase III nasal polyps trial

AstraZeneca and Amgen have announced promising results from a Phase III clinical trial for Tezspire (tezepelumab), a treatment for chronic rhinosinusitis with nasal polyps (CRSwNP). Tezspire, a thymic stromal lymphopoietin (TSLP) inhibiting monoclonal antibody, has shown significant improvements in reducing the size of nasal polyps and alleviating nasal congestion compared to a placebo. These findings come from the WAYPOINT study (NCT04851964), which enrolled 416 patients with severe CRSwNP.

The primary goals of the study were to measure changes from baseline at 52 weeks in total nasal polyp size, assessed through the endoscopic total Nasal Polyp Score, and the mean nasal congestion over two weeks, evaluated via the patient-reported Nasal Congestion Score. While the detailed results of the study are yet to be disclosed, AstraZeneca and Amgen plan to share this data with regulatory authorities and at upcoming medical meetings.

This positive news for Tezspire follows a mix of results from a Phase IIb trial for the therapy in treating chronic obstructive pulmonary disease (COPD). In the Phase IIa COURSE trial (NCT04039113), Tezspire did not meet its primary endpoint in combating COPD. Yet, a pre-determined subgroup analysis highlighted that in patients with higher levels of eosinophils, Tezspire reduced severe exacerbations by 48% compared to placebo. This subgroup result was notable enough for the US Food and Drug Administration (FDA) to grant Tezspire a breakthrough therapy designation in July, as an additional maintenance therapy for patients with moderate to very severe COPD characterized by an eosinophilic phenotype.

Tezspire, which had already been approved by the FDA in 2021 for treating severe asthma, fights inflammation by inhibiting TSLP. This cytokine plays a critical role in the immune system by acting similarly to interleukin (IL)-2. The recent advancements in Tezspire's clinical trials underscore its potential as a versatile therapeutic agent beyond asthma.

In the current market, Tezspire's main competitor is Dupixent (dupilumab), developed by Sanofi and Regeneron. Dupixent has been effective in treating various immune-mediated conditions including CRSwNP, asthma, and COPD. Recently, the FDA approved the expansion of Dupixent’s use to include adolescents aged 12 to 17 years.

Financially, Sanofi reported that Dupixent achieved €10.7 billion ($11.6 billion) in global sales last year. In contrast, Tezspire recorded $86 million in sales for 2023, according to AstraZeneca's reports. Despite the current disparity in revenue, GlobalData anticipates substantial growth for both treatments, forecasting that by 2030, Dupixent will generate $20.4 billion and Tezspire $3.6 billion in sales.

Beyond CRSwNP and asthma, AstraZeneca and Amgen are exploring the potential of Tezspire in treating other conditions such as chronic spontaneous urticaria and eosinophilic esophagitis (EoE). In 2021, the FDA granted Tezspire Orphan Drug Designation for EoE, recognizing its potential benefit in treating this rare condition.

In summary, Tezspire is proving to be a notable therapeutic option for a range of inflammatory conditions, with recent trials affirming its efficacy in CRSwNP. The therapy's success in clinical trials and subsequent FDA designations highlight its potential to address unmet medical needs in respiratory and immunological disorders.