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AstraZeneca: AstraZeneca advances tralokinumabto 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 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
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.


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.

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

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:


Media Enquiries

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Vanessa Rhodes +44 20 7604 8037 (UK/Global)

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