阿斯利康启动哮喘生物药tralokinumab III期项目

近两天，阿斯利康对抗辉瑞1170亿美元收购再添2枚利器。昨日，阿斯利康宣布12.6亿痛风药物lesinurad III期项目获得成功，而今日，阿斯利康又启动哮喘生物药tralokinumab III期临床项目，该项目的启动是基于IIb期研究的喜人结果。目前，数个制药巨头均在竞相开发生物哮喘药，用于对传统吸入性药物反应不佳的严重哮喘群体，业界认为，在未来，生物哮喘药市场每年的销售额将突破75亿美元。

tralokunumab III期临床项目，将调查该药用于严重控制不佳的哮喘（asthma）的治疗。tralokinumab由阿斯利康全球生物制品研发部门MedImmune研发。III期项目的启动，是基于今年5月一项IIb期研究的可喜成果，相关结果已提交至2014年美国胸科学会（ATS）国际会议。

该III期项目将在正接受吸入性糖皮质激素和长效β2激动剂治疗但病情仍未能充分控制的重度哮喘患者中开展，将评估tralokinumab降低哮喘发作频率（AER）的有效性和安全性。此外，该项目还将评估tralokinumab对肺功能、患者报告的哮喘症状和生活质量的影响，同时将探索是否存在潜在的临床生物标志物可帮助确定能够对tralokinumab治疗有响应的患者群体。

tralokinumab是一种实验性人类IgG4单克隆抗体，可强效和选择性中和白细胞介素13（IL-13）。IL-13是一种关键的细胞因子，被认为通过驱动严重、气道过度反应和粘液过多分泌，在严重而频繁的哮喘发作、肺功能受损及其他哮喘症状中发挥重要作用。

此外，阿斯利康症状开展一项II期研究，调查tralokinumab用于轻度至中度特发性肺纤维化（IPF）的治疗。

英文原文：AstraZeneca advances tralokinumab to Phase III in severe asthma

AstraZeneca today announced the start of the Phase III programme for tralokinumab, a potential treatment for patients with severe, inadequately controlled asthma, developed by MedImmune, the company’s global biologics research and development arm.

The Phase III programme will evaluate the safety and effectiveness of tralokinumab in reducing the rate of asthma exacerbations (AER) in adults and adolescents with severe, inadequately controlled asthma despite receiving inhaled corticosteroids plus long-acting β2-agonist. The programme will also assess the effect of tralokinumab on lung function, patient-reported asthma symptoms and quality of life, as well as investigate whether potential clinical biomarkers could identify patients who are more likely to respond to tralokinumab.

Tralokinumab is an investigational human monoclonal antibody which potently and selectively neutralises interleukin-13 (IL-13). IL-13 is a key cytokine that is believed to contribute to the onset of severe and frequent asthma attacks, impaired lung function and other debilitating asthma symptoms by driving inflammation, airway hyper-responsiveness and excessive mucus production.

“We are pleased to begin the tralokinumab Phase III programme in severe asthma, further strengthening the breadth of our portfolio in respiratory disease, one of AstraZeneca’s core therapy areas,” said Bill Mezzanotte, Vice President and Head of Inflammation, Neuroscience and Respiratory in AstraZeneca’s Global Medicines Development unit. “Patients with severe asthma currently have limited treatment options and need more effective therapies to control their disease. The development of tralokinumab underscores our commitment to a personalised treatment approach for these patients, to improve their lives. Severe asthma is highly heterogeneous; we are working to better understand patient subtypes, identify potential biomarkers, and tailor therapies to cellular and molecular phenotypes to achieve the best clinical outcomes.”

Initiation of the Phase III programme is based on results from a Phase IIb study conducted by MedImmune. Results from that study were presented at the 2014 American Thoracic Society (ATS) International Conference in San Diego, California in May.

The efficacy and safety of tralokinumab is also being investigated in an ongoing Phase II study in patients with mild-to-moderate idiopathic pulmonary fibrosis (IPF) over a 72-week treatment period.

NOTES TO EDITORS

About tralokinumab

Tralokinumab is a human IgG4 monoclonal antibody that targets IL-13, a key cytokine that is believed to play a key role in the pathogenesis of asthma through the promotion of inflammation, airway hyper-responsiveness, mucus hyper-secretion, airway remodeling via fibrosis, increased IgE synthesis and mast cell activation.