New data reflect advancements across novel inhaled therapies, respiratory biologics and research into underlying disease pathways
AstraZeneca will demonstrate the breadth and depth of its industry-leading respiratory disease medicines with more than 60 abstracts and scientific presentations at the American Thoracic Society (ATS) 2016 International Conference in San Francisco, California, 13-18 May 2016.
Data support AstraZeneca’s novel inhaled combinations, respiratory biologics and innovative science, which targets new pathways in asthma and chronic obstructive pulmonary disease (COPD). Highlights include:
14 abstracts focused on unmet need in COPD as well as Bevespi Aerosphere (glycopyrrolate/formoterol fumarate),recently approved by the US FDA, a novel fixed-dose dual bronchodilator pMDI utilising the latest co-suspension technology for the treatment of COPD, including 24-hour lung function data compared totiotropium bromide inhalation sprayand placebo.
Biomarker data on benralizumab, an anti–eosinophil monoclonal antibody currently in Phase III trials in both severe asthma and COPD. The data evaluate the potential for high baseline blood eosinophils as well as baseline serum biomarkers of the IL-13 pathway to predict treatment response. These data may be of value for both benralizumab and tralokinumab (IL-13 monoclonal antibody).
Data highlighting breakthrough science aimed at addressing and potentially modifying the underlying causes of respiratory diseases, with a research focus on four key biological pathways: eosinophilic disease, Th2-driven disease, epithelial-driven pathobiology and autoimmunity.
In addition, data will be presented evaluating the effects on lung function and airway inflammation of Daxas (roflumilast), the oral PDE4 inhibitor, initiated in addition to standard therapy with corticosteroids and antibiotics at the onset of an acute exacerbation of COPD.
Tom Keith-Roach, Vice President, Global Product Strategy for Respiratory, Inflammation and Autoimmunity, said: “Respiratory is one of AstraZeneca’s main therapy areas and it’s exciting that the data being shared at ATS demonstrate how rapidly our pipeline and portfolio are developing. We believe Bevespi Aerosphere and investigational medicines such as benralizumab can make a real difference in the lives of patients living with respiratory conditions worldwide.”
AstraZeneca key presentations at ATS 2016:
|Lead author||Abstract title||Presentation details|
|Ding B||A cross-sectional assessment of the burden of chronic obstructive pulmonary disease (COPD) symptoms in the United States and Europe using the National Health and Wellness Survey||Oral Tuesday, 17 May, 3:00 PM Abstract #A6156|
|PINNACLE-1 & PINNACLE-2 Martinez F||Pooled analyses from PINNACLE-1 and -2; the novel LAMA/LABA co-suspension technology glycopyrrolate/formoterol fixed-dose combination delivered by MDI shows significant improvement versus monocomponents in patients with COPD|| |
Wednesday, 18 May, 9:00 AM Abstract #A6782
|PINNACLE-3 Hanania N||Safety and efficacy of a novel LAMA/LABA co-suspension technology glycopyrrolate/formoterol fixed-dose combination delivered by MDI: Results of a one-year extension study in patients with COPD (PINNACLE-3)||Wednesday, 18 May, 9:00 AM Abstract #A6791|
|Arora S||24-hour lung function profile of novel co-suspension glycopyrrolate/formoterol metered dose inhaler versus placebo and Spiriva® Respimat®, in patients with moderate-to-very-severe chronic obstructive pulmonary disease||Wednesday, 18 May, 9:00 AM Abstract #A6823|
|Arora S||24-hour lung function following the novel LAMA/LABA co-suspension technology of glycopyrrolate/formoterol fixed-dose combination MDI, in patients with moderate-to-very-severe COPD||Wednesday, 18 May, 9:00 AM Abstract #A6792|
|Martinez F||The novel LAMA/LABA co-suspension technology of glycopyrrolate/formoterol fixed-dose combination MDI significantly improves health status in symptomatic patients with COPD||Wednesday, 18 May, 9:00 AM Abstract #A6784|
|Mack P||Drug delivery from a novel LAMA/LABA co-suspension technology of glycopyrrolate/formoterol fixed-dose combination MDI: Evidence of consistency, robustness and patient-use reliability||Tuesday, 17 May, 9:00 AM Abstract #A5839|
|Orevillo C||Pharmacokinetic and safety profile of a novel co-suspension technology fixed-dose combination of budesonide/glycopyrrolate/formoterol delivered by metered dose inhaler (PT010) in healthy adult subjects||Wednesday, 18 May, 9:00 AM Abstract #6827|
SYMBICORT (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol
|Inoue H||Proportion and characteristics of asthma– chronic obstructive pulmonary disease (COPD) overlap syndrome among COPD patients in Japan||Late-Breaker Poster Discussion Tuesday, 17 May, 2:15 PM-4:15 PM Abstract #A7889|
|Newbold P||High blood eosinophil concentrations and serum biomarkers of low IL-13 pathway activation at baseline predict exacerbation rate reduction by benralizumab for patients with moderate to severe asthma||Monday, 16 May, 2:15 PM Abstract #A4351|
|Ranade K||Dipeptidyl peptidase 4 (DPP4) is a novel predictive biomarker for the investigational anti-IL13 targeted therapy tralokinumab||Monday, 16 May, 2:15 PM Abstract #A4332|
|Beier J ||Improvement in lung function and symptom control with aclidinium bromide versus tiotropium and placebo in symptomatic patients with COPD: post-hoc analysis of a Phase IIIb study||Wednesday, 18 May 9:00 AM Abstract #6817|
|The effect of aclidinium bromide 400 µg on lung function, sleep quality and physical activity in patients with chronic obstructive pulmonary disease: Results of a Phase IV pilot study||Wednesday, 18 May 9:00 AM Abstract #6820|
|Miravitilles M||Efficacy of aclidinium/formoterol on bronchodilation and symptoms in symptomatic and asymptomatic patients with COPD: pooled analysis of two Phase III studies||Wednesday, 18 May 9:00 AM Abstract #6773|
|Singh D||Reduction in clinically important deterioration in chronic obstructive pulmonary disease in patients treated with aclidinium/formoterol combination||Wednesday, 18 May 9:00 AM Abstract #A6771|
|TREAT Mackay AJ||Roflumilast initiated at onset of acute exacerbation of COPD enhances lung function recovery: results from the randomised, double-blind, placebo-controlled, parallel-group trial, Treatment with Roflumilast at ExAcerbaTion (TREAT)||Tuesday, 17 May 9:00 AM Abstract #A5180|
|TREAT Mackay AJ||Reduction of airway inflammation with roflumilast initiated at onset of acute exacerbation of COPD: results from the randomised, double-blind, placebo-controlled, parallel-group trial, Treatment with Roflumilast at ExAcerbaTion (TREAT)||Tuesday, 17 May 9:00 AM Abstract #A5181|
Emerging and Disease Modification Science
|Mardh CK||A novel inhaled non-steroidal modulator of inflammation for the control of asthma; AZD7594||Sunday, 15 May, 9:00 AM Abstract #A1329|
|Jackson S||Safety and tolerability of AZD1419, an inhaled oligonucleotide-based toll-like receptor 9 agonist in healthy volunteers: a potential new therapy for asthma||Sunday, 15 May, 9:00 AM Abstract #A1326|
|Goransson M||SIK inhibition: A novel opportunity to modulate disease phenotype in COPD||Tuesday, 17 May, 9:00 AM Abstract #5837|
Asthma is a common, chronic condition in which inflammation and narrowing of the airways may cause wheezing, breathlessness, chest tightness and coughing. Despite current and available treatment options, asthma continues to effect the health and day-to-day lifestyles of more than 300 million children, men and women worldwide. By 2020, asthma will likely increase in numbers to affect as many as 400 million people.
Approximately 10% of asthma is severe, of which a reported 40% is uncontrolled. Severe, uncontrolled asthma has eight times higher risk of mortality. Uncontrolled asthma can lead to a dependence on oral corticosteroids (OCS). Systemic steroid exposure leads to serious & irreversible adverse effects, including osteoporosis, anxiety, depression, weight gain, glaucoma and diabetes. There is also a significant physical and socio-economic burden of asthma with 10% of severe patients accounting for 50% of asthma related health costs.
COPD (chronic obstructive pulmonary disease) is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure, which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. It affects an estimated 329 million people worldwide and is predicted to be the third leading cause of death by 2030. Improving lung function and managing daily symptoms such as breathlessness are important to the management of COPD. It is estimated that eight out of 10 patients suffer symptoms at night, such as an irritative cough and difficulty breathing, frequent nocturnal awakenings, which leads to insomnia, worry and anxiety.
About Respiratory, Inflammation and Autoimmunity Diseases
Respiratory, Inflammation and Autoimmunity (RIA) is one of AstraZeneca’s main therapy areas, and we have a growing portfolio of medicines that reached more than 17 million patients in 2015. Our strong pipeline has the potential to deliver up to seven launches between 2016 and 2020. In respiratory disease, our aim is to transform asthma and COPD treatment through inhaled combinations at the core of care; precision biologics for the unmet needs of specific patient populations, and scientific advancements in disease modification. We are building on a 40-year heritage in respiratory disease, and our capability in inhalation technology spans both pressurised metered-dose inhalers (pMDIs) and dry powder inhalers (DPIs), as well as our unique Co-Suspension Technology.
In Inflammation and Autoimmunity, our aim is to develop innovative therapies for the treatment of autoimmune and rheumatoid diseases, with a lead programme in systemic lupus erythematosus. Across respiratory, inflammation and autoimmune diseases, our research is focused on four key biological pathways: eosinophilic disease, Th2-driven disease, epithelial-driven pathobiology, and autoimmunity.
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.
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Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease,
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