Benralizumab phase II COPD study published in the Lancet Respiratory Medicine

Results are among key AstraZeneca respiratory data being presented at 2014 European Respiratory Society International Congress

AstraZeneca today announced that The Lancet Respiratory Medicine has published encouraging safety and efficacy data from a Phase IIa study evaluating its novel investigational monoclonal antibody benralizumab in patients with chronic obstructive pulmonary disease (COPD).

The study, conducted by MedImmune, the company’s global biologics research and development arm, evaluated the safety and efficacy of benralizumab in 101 adults with moderate-to-severe COPD and experiencing at least one acute exacerbation requiring oral corticosteroids, antibiotics, or hospitalisation in the past year. The overall patient population for the study was selected on the basis of elevated levels of eosinophils in sputum. The primary endpoint in the study was not met, as benralizumab did not reduce the acute exacerbation rate compared with placebo in the overall patient population. However, benralizumab demonstrated clinically significant improvements in lung function in the overall population.

In addition, in the pre-specified analyses, the study indicated that benralizumab reduced COPD exacerbations and improved other symptoms of COPD in certain patient groups. Patients treated with benralizumab who had higher baseline levels of eosinophils in their blood showed greater improvements in COPD symptoms, including exacerbation rate, lung function and disease-specific health status as measured by the Saint George’s Respiratory Questionnaire-COPD (SGRQ-C) versus placebo-treated subjects.

There was a higher incidence of serious treatment-emergent adverse events (TEAEs) in the benralizumab group compared with placebo (14 vs 9). Overall, TEAEs were similar across treatment and placebo groups.

These data will be presented in a poster session at the 2014 European Respiratory Society (ERS) International Congress in Munich, Germany, on 8 September 2014, along with key data from AstraZeneca’s broad respiratory portfolio.

Benralizumab is an anti-interleukin-5 receptor alpha monoclonal antibody that depletes blood and sputum eosinophils, a type of white blood cell. Elevated levels of eosinophils are associated with the cause and severity of COPD attacks, as well as asthma and asthma exacerbations. Eosinophilic airway inflammation is believed to be present in between 20 and 30 percent of the 210 million people who suffer from COPD worldwide.

“Benralizumab is the first biological agent to show marked reduction in eosinophilic inflammation and beneficial effects in COPD, indicating a potential new way to treat patients with severe COPD symptoms,” said lead investigator Professor Christopher Brightling, University of Leicester, Glenfield Hospital, Department of Respiratory Medicine. “The strength of these results reinforces the further development of this molecule for COPD.”

“COPD is a highly heterogeneous disease and we are working to better understand patient subtypes, identify potential biomarkers and tailor therapies to achieve the best outcomes for patients,” said Bing Yao, Senior Vice President and Head of MedImmune’s Respiratory, Inflammation and Autoimmunity Innovative Medicines Unit. “Respiratory disease is a core therapeutic area for AstraZeneca and we are encouraged by these results indicating benralizumab’s potential to help certain groups of patients. We look forward to the further development of this promising new biologic as we progress our Phase III programmes in both COPD and severe asthma.”

Detailed results and safety data from the trial were published in The Lancet Respiratory Medicine and can be viewed here. These are believed to be the first clinical data published on a potential biologics treatment for eosinophilic COPD.

AstraZeneca announced the start of the Phase III programme for benralizumab in COPD at the company’s second quarter and half year results on 31 July 2014.

Key AstraZeneca Data to be Presented at ERS

In addition, over 20 scientific abstracts from AstraZeneca and MedImmune are being presented at ERS. Other accepted abstracts of note include:

• #P2818 LATE-BREAKING ABSTRACT: Phase IIa study showed that benralizumab did not reduce the exacerbation rate in subjects with COPD and elevated airway eosinophils, but significantly improved lung function with an acceptable safety profile

Thematic Poster Session: Latest insights in airway diseases, Monday 8 September, 12:50-14:40 CEST

• #2909 LATE-BREAKING ABSTRACT: Benralizumab reduced asthma exacerbations and improved lung function, and asthma control in adults with uncontrolled eosinophilic asthma and has promise as a novel therapy in this patient population

Oral Presentation: The future has started: emerging potentials for personalised asthma treatment, Monday 8 September, 15:30 – 15:45 CEST

• #1891 Pearl's PT010 triple combination provides comparable budesonide exposure to Symbicort and comparable glycopyrronium and formoterol exposure to PT003

Oral Presentation: Bronchodilators for asthma and COPD, Monday 8 September, 10:45-12:45 CEST

• #4672 AMG 157 (MEDI9929) showed a reduction in sputum eosinophils, blood eosinophils and FeNO markers of airway and systemic inflammation in AMG 157-treated subjects, which supports a role for TSLP in allergen-induced responses in patients with allergic asthma Oral Presentation: Clinical trials of drugs for respiratory diseases, Wednesday 10 September, 10:00 – 10:15 CEST

-ENDS-

About benralizumab

Benralizumab is a humanised monoclonal antibody directed at the alpha sub-unit of the interleukin-5 receptor (IL-5Rα) that depletes eosinophils, a key target cell in inflammatory respiratory disease. Scientific literature supports that eosinophil levels are associated with exacerbations and increased eosinophils are associated with frequent exacerbations.

Benralizumab is currently in Phase III development for both COPD and severe asthma.

Benralizumab is in-licensed from BioWa, Inc., a wholly-owned subsidiary of Kyowa Hakko Kirin Co., Ltd.

About COPD and severe asthma

An estimated 210 million people suffer from Chronic Obstructive Pulmonary Disease (COPD) worldwide, and it is predicted to be the third leading cause of death by 2020. Eosinophilic airway inflammation is associated with about 20-30 percent of patients with COPD.

An estimated 5 to 10 percent of the 300 million people worldwide who suffer from asthma have a severe form, and people with eosinophilic airway inflammation represent approximately 40 to 60 percent of the severe asthmatic population.

About MEDI9929/AMG 157

MEDI9929/AMG 157 is a monoclonal immunoglobulin IgG2λ that binds to and inhibits Thymic stromal lymphopoietin (TSLP) from interacting with its receptor. TSLP is a cytokine that is believed to play a critical role in the start of the allergic cascade, specifically the inflammatory response, and is generated by lung tissue when an allergen is introduced.

MEDI9929/AMG 157 is being jointly developed by Amgen and AstraZeneca and is currently in Phase II development for the treatment of asthma

About MedImmune

MedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic areas, including respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D centers. For more information, please visit www.medimmune.com.

About AstraZeneca

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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