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    Home > Biochemistry News > Biotechnology News > The AstraZeneca/Amtezepelumab Phase III asthma trial reached its main end point

    The AstraZeneca/Amtezepelumab Phase III asthma trial reached its main end point

    • Last Update: 2021-02-24
    • Source: Internet
    • Author: User
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    Recently, the phase 3 trial of the drug tezepelumab, a partnership between Amjin and AstraZeneca, in patients with severe asthma, reached its main destination.
    compared to placebo plus standard treatment, the average annual acute asthma attack rate (AAER) in patients decreased statistically and clinically after 52 weeks of combined standard treatment.
    to date, leading asthma drugs such as Dupixent and AstraZeneta Fasenra, a partnership between Regenerative and Sanofi, have been approved for use in patients with acidic granulocytic asthma.
    up to 50% of asthma sufferers are not eosinophilic asthma, and clinically effective treatment options for such patients are now limited.
    and AstraZeneca hope that tezepelumab, which requires only one injection a month, will meet this clinical need.
    the drug is a human-sourced antithyclonal cytokine TSLP monoclonal antibody that targets and blocks thymus-based lymphocyte production (TSLP).
    TSLP is an important corted cytokine, which is an upstream regulatory factor for multiple inflammatory pathways in a variety of diseases, including asthma, and is essential for the occurrence and continuity of airway inflammation.
    Previously, the drug's positive Phase 2 trial data were impressive, with results showing that tezepelumab therapy reduced acute asthma attacks by as much as 71% per year, and more importantly, phase 3 positive trial results showed that the drug had greater prospects for asthma.
    and AstraZeneca have yet to release detailed data on the late-stage trial, but they cite the efficacy of tezepelumab for non-eosinophilic patients and the broader population with severe asthma.
    Compared to the placebo control group, tezepelumab combined standard treatment options (moderate or high dose inhalation of corticosteroids, at least one additional asthma control drug, with or without oral corticosteroids) reduced acute asthma onset rates in the general population and non-eosinophilic subgroups.
    data show that the drug is effective in patients with higher levels of eosinophils and can be therapeutic even in patients below the acidic granulocyte baseline standard (less than 150).
    M. Reese, executive vice president of research and development at Amgen, said, "We are very excited about the main results of the NAVIGATOR study, regardless of the number of people, regardless of the count of eosinophils."
    the drug represents a potentially new biologic agent that enables us to treat severe asthma at the top of the inflammatory cascade response, addressing the highly unsealed needs of millions of patients worldwide with severe asthma.
    believe tezepelumab may have revolutionary properties that can be demonstrated even in patients with low eosinophil counts.
    "Because of the drug's unique mechanism of action and the lack of similar drug risk data, adverse events associated with the tezepelumab drug have also become areas of focus for test data.
    and AstraZeneca said tezepelumab was well-to-do.
    preliminary analysis, the two companies found no "significant clinical difference" between the safety results of tezepelumab and the control group.
    Phase III trial, NAVIGATOR, was one of two trials initiated by Amway and AstraZeneca on the basis of Phase II data, compared with the relatively small phase III trial SOURCE, which was designed to assess whether tezepelumab reduced the daily oral corticosteroid hormone use in patients while controlling asthma.
    , AstraZeneca initially submitted a clinical trial application for tezepelumab in early 2018 and was approved.
    According to the China Drug Clinical Trial Registration and Information Disclosure Platform, the drug is currently undergoing two clinical trials in China (one completed and one in the process of patient recruitment), with additional maintenance treatment for patients aged 12 and over with severe asthma and treatment for severe asthma (adults).
    sources: 1, Amgen, AstraZeneca's tezepelumab hits goal in asthma phase 3 2, Amgen and AstraZeneca's Tezepelumab Looking to First Be-in-Class Asthma Treatment
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