Blueprint
FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of May 2017
Commission
File Number: 001-11960
AstraZeneca PLC
1
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Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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This
announcement contains inside information
10 May
2017 07:00 BST
ASTRAZENECA PROVIDES UPDATE ON STRATOS 1 PHASE III TRIAL OF
TRALOKINUMAB IN SEVERE, UNCONTROLLED ASTHMA
Tralokinumab did not meet its primary endpoint of a significant
reduction in the annual asthma exacerbation rate
Second pivotal Phase III trial STRATOS 2 is ongoing with results
expected in second half of 2017
AstraZeneca and MedImmune, its global biologics research and
development arm, today announced that tralokinumab, an
anti-interleukin-13 (IL-13) human monoclonal antibody, did not meet
its primary endpoint of a significant reduction in the annual
asthma exacerbation rate (AAER) in the overall population of
severe, uncontrolled asthma patients, compared with placebo in
STRATOS 1, the first of two pivotal Phase III trials.
In a planned analysis, a clinically-relevant reduction in AAER was
observed in a sub-population of patients with an elevated biomarker
associated with increased IL-13 activity. This sub-group of
patients will now be the focus for the future analysis of STRATOS
2, the second ongoing pivotal Phase III trial.
Sean Bohen, Executive Vice President, Global Medicines Development
and Chief Medical Officer, said: "Severe asthma is a heterogeneous
disease with significant unmet needs and we will now await the
STRATOS 2 results in the second half of 2017 to explore the
potential to treat a sub-group of uncontrolled asthma patients with
tralokinumab."
The STRATOS 1 and STRATOS 2 trials evaluate the efficacy and safety
of tralokinumab in reducing the rate of asthma exacerbations in
adults and adolescents with severe asthma, inadequately controlled
despite receiving inhaled corticosteroids (ICS) plus long-acting
beta2-agonist (LABA). STRATOS 1 explored the potential to use
biomarkers to identify patients with an enhanced response to
tralokinumab. STRATOS 2 is designed to validate the biomarker
population identified in STRATOS 1.
The safety and tolerability findings in STRATOS 1 were consistent
with those observed in previous trials with tralokinumab. A full
evaluation of the data is ongoing and the results will be submitted
for presentation at a forthcoming medical meeting.
Potential future regulatory submissions for tralokinumab will be
dependent on the combined analysis of both STRATOS 1 and STRATOS 2,
the two pivotal trials in the ATMOSPHERE clinical programme (see
below).
About Severe Asthma
Asthma affects 315 million individuals worldwide1,
and up to 10% of asthma patients have severe
asthma,2,3
which may be
uncontrolled despite high doses of standard-of-care asthma
controller medicines and can require the use of chronic oral
corticosteroids (OCS)4.
Severe, uncontrolled asthma is debilitating and potentially fatal
with patients experiencing frequent exacerbations every year and
significant limitations on lung function and quality of life.
Severe, uncontrolled asthma has an eight times higher risk of
mortality than severe asthma. There is also a significant physical
and socio-economic burden of severe asthma with these patients
accounting for 50% of asthma-related costs5.
About the ATMOSPHERE Programme
The ATMOSPHERE programme is comprised of 2,298 patients at 571
sites across 27 countries including the pivotal efficacy trials,
STRATOS 1 and STRATOS 2, along with the TROPOS, MESOS and Japan
Long-Term Safety (LTS) trials.
STRATOS 1 and 2 are Phase III multicentre, randomised,
double-blinded, parallel-group, placebo-controlled trials designed
to evaluate the efficacy and safety of a regular, subcutaneous
administration of tralokinumab for 52 weeks in adult and adolescent
patients with severe asthma inadequately controlled despite
treatment with ICS plus LABA.
TROPOS is a Phase III multicentre, randomised, double-blinded,
parallel-group, placebo-controlled trial for 40 weeks in adult and
adolescent patients with severe asthma who require continuous
treatment with ICS plus LABA, and chronic treatment with
maintenance oral corticosteroid (OCS) therapy.
MESOS is a Phase II multicentre, randomised, double-blinded,
parallel group, placebo-controlled trial for 12 weeks in adults
with uncontrolled asthma requiring continuous treatment with ICS,
with or without other asthma controllers.
Japan LTS is an open-label, multicentre trial to evaluate the
safety of tralokinumab for 52 weeks in Japanese adults and
adolescents with asthma inadequately controlled on ICS plus
LABA.
About Tralokinumab
Tralokinumab is an anti-IL-13 human immunoglobulin-G4 monoclonal
antibody that blocks binding and signalling of IL-13 to IL-13
receptors. IL-13 is an important signalling protein that is a key
driver in asthma. When IL-13 binds to receptors (IL-13Ra1 and
IL-13Ra2) found on cells in the airways, it can lead to
inflammation, hypersensitivity and structural changes.
About AstraZeneca in Respiratory Disease
Respiratory disease is one of AstraZeneca's main therapy
areas, and we have a growing portfolio of medicines that reached
more than 18 million patients in 2016. Our aim is to transform
asthma and COPD treatment through inhaled combinations at the
core of care, 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 innovative Co-SuspensionTM Delivery Technology.
Our biologics include tralokinumab, benralizumab (anti-eosinophil,
anti-IL-5rɑ), which has been accepted for regulatory review in
the US, EU and Japan and tezepelumab (anti-TSLP), which
successfully achieved its Phase IIb primary endpoint. Our research
is focused on addressing underlying disease drivers focusing on the
lung epithelium, lung immunity and lung regeneration.
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 commercialization of
small molecule and biologic prescription medicines. MedImmune is
pioneering innovative research and exploring novel pathways across
Oncology, Respiratory, Cardiovascular & Metabolic Diseases, and
Infection and Vaccines. The MedImmune headquarters is in
Gaithersburg, Md., one of AstraZeneca's three global R&D
centres, with additional sites in Cambridge, UK and Mountain View,
CA. For more information, please visit www.medimmune.com.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that
focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of diseases in
three main therapy areas - Oncology, Cardiovascular &
Metabolic Diseases and Respiratory.
The Company also is selectively active in the areas of
autoimmunity, neuroscience and infection. 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 and
follow us on Twitter @AstraZeneca.
Media Enquiries
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+44 203 749 5712
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Adrian Kemp
Company Secretary, AstraZeneca PLC
References
1.
To T, Stanojevic S, Moores G et al. Global asthma prevalence in
adults: findings from the cross-sectional world health survey. BMC
Public Health 2012;12:204.
2. World Health
Organization. Chronic Respiratory Diseases. Global surveillance,
prevention and control of chronic respiratory diseases - a
comprehensive approach. 2007. Available from: http://www.who.int/gard/publications/GARD%20Book%202007.pdf
(Accessed 9 May
2016).
3.
Price D, Fletcher M, van der Molen T. Asthma control and management
in 8,000 European patients: the REcognise Asthma and LInk to
Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med
2014;24:14009.
4.
Adelphi Real World Respiratory Disease Specific Programme. Asthma
patient data file. Uncited raw data, cited with permission.
Bollington: Adelphi Real World, 2011-2014.
5. World Allergy Organization (WAO).
The management of severe asthma: economic analysis of the cost of
treatments for severe asthma. Available from: http://www.worldallergy.org/educational_programs/world_allergy_forum/anaheim2005/blaiss.php.
Last accessed May 2017.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
AstraZeneca
PLC
Date:
10 May 2017
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
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