MIRACLE Phase III Trial Results Published: Benralizumab Reduces Annual Asthma Exacerbation Rate by 74% in Patients with Severe Eosinophilic Asthma

China Finance and Economics News, April 11th: AstraZeneca recently announced that the research results of the MIRACLE III Phase trial have been published in the journal *Respiratory Medicine*.

The study results showed that, in patients with severe eosinophilic asthma (SEA) who had not been controlled by standard treatment in multiple Asian countries including China, compared with placebo (benralizumab n=236, placebo n=237), treatment with Fasenra (generic name: benralizumab) reduced the annualized asthma exacerbation rate (AAER) by 74% over 48 weeks (hazard ratio 0.26 [95% confidence interval (CI) 0.19, 0.36], p<0.0001), which was statistically significant and clinically meaningful.

The MIRACLE study is a randomized, double-blind, placebo-controlled clinical trial. The participants are asthma patients who were not effectively controlled with medium to high doses of inhaled corticosteroids plus long-acting β2-agonists (ICS-LABA) treatment (with or without oral corticosteroids (OCS) and other asthma control medications). Patients were randomly assigned in a 1:1 ratio to receive either 30mg of benralizumab subcutaneous injection or placebo treatment for 48 weeks.

Uncontrolled severe eosinophilic asthma imposes a significant disease burden, including poor symptom control, reduced quality of life, and high exacerbation rates. In China, the incidence of severe asthma with an eosinophilic phenotype is rising, but treatment options remain limited. Data shows that in China, approximately 8-10% of asthma patients (with a total asthma population of about 46 million) suffer from severe asthma, of which up to 76.8% have severe eosinophilic asthma. However, a considerable number of asthma patients in China remain undiagnosed and undertreated.

International coordinating investigator of the MIRACLE study, academician of the Chinese Academy of Engineering, and recipient of the Medal of the Republic, Academician Nanshan Zhong, stated that the results of the MIRACLE trial confirmed that for Chinese patients with severe eosinophilic asthma, the anti-IL-5 receptor monoclonal antibody (Benralizumab) can rapidly and durably control asthma symptoms and significantly reduce the annual exacerbation rate. "Encouragingly, the study also showed that Benralizumab was highly effective in asthma populations not well-controlled by medium-dose ICS/LABA."

Professor Lai Kefang, principal investigator of the MIRACLE trial in China, Chairman of the Chinese Cough Consortium, Director of the Clinical Trials Department at the National Key Laboratory of Respiratory Diseases, Deputy Head of the Asthma Group under the Respiratory Disease Society of the Chinese Medical Association, and Deputy Head of the Asthma and Allergic Reactions Working Group under the Respiratory Physicians Association of the Chinese Medical Doctor Association, stated, "Severe eosinophilic asthma is a debilitating disease that significantly impacts quality of life. In China, many patients still experience inadequate control of their condition despite using medium to high doses of inhaled therapy, leading to frequent acute exacerbations, worsening symptoms, and declining lung function." The results of the MIRACLE trial in China are encouraging, confirming the clinical efficacy of the IL-5 receptor monoclonal antibody (Benralizumab) in patients with poorly controlled severe eosinophilic asthma."

"The positive results of MIRACLE are great news for doctors and patients with severe eosinophilic asthma in China and other Asian markets with unmet medical needs," said Dr. He Jing, Senior Vice President of AstraZeneca and Head of the Global R&D China Center. "These data further provide increasing evidence for benralizumab in the treatment of severe eosinophilic asthma and offer additional support for AstraZeneca's application to the National Medical Products Administration for the approval of benralizumab in this indication."