New Data Further Reinforce Efficacy of TEZSPIRE™ (tezepelumab-ekko) in a Broad Population of Severe Asthma Patients

News on February 28, 2022 /BioValleyBIOON/ -- Amgen recently in 2022 American Academy of Allergy, Asthma andImmunologyResults from a pooled post-hoc analysis of the pivotal Phase 3 NAVIGATOR trial and Phase 2b PATHWAY trial evaluating Tezspire (tezepelumab-ekko) in patients with severe asthma were presented at the annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI). The data showed,In the entire severe asthmaBiomarkerIn the subgroup, Tezspire treatment significantly reduced the annualized asthma exacerbation rate (AAER).. These findings support Tezspire as a first-in-class therapy for a broad range of severe cases.AsthmaThe Role of Patients, Regardless of TheirBiomarkerHow about the level.

In the pooled analysis,Regardless of baseline blood eosinophil countDuring the 52-week treatment period, compared with placebo + standard of care (SoC), the Tezspire + SoC regimen reducedAsthmaAggravation (asthma exacerbation) demonstrated consistent efficacy in terms of AAER: 71% (≥300 cells/microliter), 48% (<300 cells/microliter), and 48% (<150 cells/microliter). In the same analysis,Regardless of the fractional exhaled nitric oxide (FeNO) levels and allergic statusDuring the 52-week treatment period, the Tezspire+SoC regimen showed improvement in AAER compared to placebo+SoC.

In addition, in the pre-specified exploratory analysis of the NAVIGATOR trial,Tezspire Demonstrates Consistent Efficacy During 52-Week Treatment, Regardless of SeasonData show that, compared with placebo, Tezspire treatment reduced AAER by 63% (winter), 46% (spring), 62% (summer), and 54% (autumn). In all seasons, the proportion of patients with worsening conditions in the Tezspire group was lower than that in the placebo group.

Most patients with severe asthma have multiple inflammatory drivers, triggered by allergens, viruses, andBacteriaInfections and air pollution trigger, all of which may lead to continuous deterioration. These new results highlight Tezspire's ability to reduce severe conditions in patients.AsthmaThe potential for deterioration, regardless of biomarker levels and seasonal triggers.

Amgen’s Executive Vice President of Research and Development, Dr. David M. Reese, stated: "Based on the latest analysis results from the NAVIGATOR and PATHWAY trials, we are pleased to continue seeing a reduction in asthma exacerbations in patients treated with Tezspire. These results further reinforce our belief that Tezspire has the potential to be a transformative medicine for patients with severe asthma, regardless of season or severity."Asthma"The specific type."

Mechanism of Action of Tezepelumab (Image Source: Literature PMID:33050900)

In December 2021, Tezspire received approval from the U.S. FDA: as an add-on maintenance therapy for the treatment of pediatric and adult patients aged ≥12 years with severe asthma. Tezspire was approved through the priority review process. In September 2018, the United StatesFDAGranted tezepelumab for the treatment of severe non-eosinophilic phenotypeAsthmaBreakthrough Therapy Designation (BTD).

Tezspire is a first-in-class biologic for the treatment of severe asthma, acting at the top of the inflammatory cascade by blocking thymic stromal lymphopoietin (TSLP). TSLP is an epithelial cell cytokine that plays a key role in...AsthmaPlays a key role in inflammation.

It is worth mentioning that,In the treatment of severe asthma, Tezspire is the first and only biologic without a phenotype (such as eosinophilic or allergic) orBiomarkerRestricted biologics. This is the first time for many severeAsthmaPatients have the opportunity to receive treatment regardless of the inflammatory cause of their disease.

Severe asthma has always been a complex disease. About 60% of patients have multiple disease drivers and may respond poorly to existing treatments. Due to the severityAsthmaThe complexity and heterogeneity, despite some progress in recent years, many patients still often experience worsening conditions, increased risk of hospitalization, and significantly reduced quality of life.

The launch of Tezspire has the potential to transform the treatment for a wide range of patients with severe asthma. In Phase 2 and Phase 3Clinical TrialIn China, regardless of the keyBiomarker(Including: eosinophil count, allergic status, fractional exhaled nitric oxide [FeNO]), Tezspire consistently and significantly reduces asthma exacerbations, including severe cases across a broad spectrum.AsthmaPatient.

TSLP is an epithelial cytokine produced in response to pro-inflammatory stimuli, such as inhaled allergens, viruses, and other pathogens in the lungs, playing a key role in the onset and persistence of airway inflammation. TSLP drives the release of downstream T2 cytokines, including IL-4, IL-5, and IL-13, leading to inflammation and asthma symptoms. TSLP can also activate various types of cells involved in non-T2-driven inflammation. Therefore, the early upstream activity of TSLP in the inflammatory cascade has been identified as a potential target in a broad population of asthma patients. Blocking TSLP can prevent immune cells from releasing pro-inflammatory cytokines, thereby preventing asthma exacerbations and improving symptoms.AsthmaControl.

Tezspire's active pharmaceutical ingredient is tezepelumab, a first-in-class anti-TSLP monoclonal antibody that specifically binds to human TSLP and blocks its interaction with the receptor complex. This prevents the release of pro-inflammatory cytokines from TSLP-targeted immune cells, thereby preventing asthma attacks and improving asthma control. By acting on the early upstream of the inflammatory cascade, tezepelumab may be suitable for a wide range of severe uncontrolled asthma cases.AsthmaPatients, regardless of patient phenotype or T2BiomarkerStatus.

Severe asthma is a debilitating disease that affects approximately 34 million people worldwide. Due to the complexity of severe asthma, many patients continue to experience symptoms despite receiving standard-of-care inhaled medications, currently available biologic therapies, and oral corticosteroids (OCS).AsthmaPatients will continue to experience symptoms and frequent exacerbations.

Tezspire works differently from any other asthma biologic, targeting multiple inflammatory pathways that contribute to asthma symptoms and exacerbations. Tezspire has the potential to transform the lives of a broad population of severely underserved patients.AsthmaCare for the patient population, including those without an eosinophilic phenotype.

Currently, Tezspire is beingAstraZenecaCo-developed with Amgen. The industry believes that the approval and market launch of Tezspire will...AsthmaThe therapeutic area is掀起一场腥风血雨, and its target patient population will far exceed that of currently marketed biologic therapies, includingGSK(GSK)'s Nucala (mepolizumab, targeting IL-5), Teva's Cinqair (reslizumab, targeting IL-5), and biologic therapies currently in development for asthma treatment, such as AstraZeneca's own benralizumab (targeting the IL-5 receptor α subunit [IL-5Rα]) and Sanofi's Dupixent (targeting IL-4/IL-13), all four of these therapies only target specific inflammatory molecules driving asthma inflammation and are only suitable for certain types of severe asthma patients, namely subgroup patients, such as those with eosinophilic asthma.Asthma. (Bioon.com)

Source of the original text:NEW DATA FURTHER REINFORCE EFFICACY OF TEZSPIRE™ (TEZEPELUMAB-EKKO) IN A BROAD POPULATION OF SEVERE ASTHMA PATIENTS