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 November
2017
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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This announcement contains inside information
1 November 2017 07:00 GMT
ASTRAZENECA PROVIDES UPDATE ON TRALOKINUMAB PHASE III PROGRAMME IN
SEVERE, UNCONTROLLED ASTHMA
AstraZeneca
and its global biologics research and development arm, MedImmune,
today announced the top-line results of the Phase III STRATOS 2 and
TROPOS trials for tralokinumab, an anti-interleukin-13 (IL-13)
human monoclonal antibody, in severe, uncontrolled
asthma.
In
STRATOS 2, tralokinumab did not achieve a statistically-significant
reduction in the annual asthma exacerbation rate (AAER), the
primary endpoint, in patients with severe, uncontrolled asthma and
elevated levels of a biomarker, Fractional exhaled Nitric Oxide
(FeNO), compared to placebo.
In TROPOS, tralokinumab did not achieve a statistically-significant
reduction in oral corticosteroid (OCS) use, the primary endpoint,
when added to the standard of care, in patients dependent on
OCS.
Sean
Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer, said: "The results are disappointing as we
had hoped that tralokinumab would benefit patients with severe
asthma, which is a complex disease with limited treatment options
today."
FeNO is a well-established biomarker for airway inflammation and
was identified in the previous pivotal trial (STRATOS 1) as most
likely to predict an enhanced response to
tralokinumab.
The safety and tolerability findings in STRATOS 2 and TROPOS were
consistent with those observed in previous trials with
tralokinumab.
Full data from STRATOS 1, STRATOS 2 and TROPOS will be presented at
a forthcoming medical meeting.
About Severe Asthma
Asthma affects 315 million individuals worldwide, and up to 10% of
asthma patients have severe asthma, which may be uncontrolled
despite high doses of standard-of-care asthma controller medicines
and can require the use of chronic OCS.
Severe, uncontrolled asthma is debilitating and potentially fatal
with patients experiencing frequent exacerbations and significant
limitations on lung function and quality of life.
Severe, uncontrolled asthma can lead to a dependence on OCS, with
systemic steroid exposure potentially leading to serious short- and
long-term adverse effects, including weight gain, diabetes,
osteoporosis, glaucoma, anxiety, depression, cardiovascular disease
and immunosuppression. There is also a significant physical and
socio-economic burden of severe, uncontrolled asthma with these
patients accounting for 50% of asthma-related costs.
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 FeNO
In asthma, FeNO (fractional exhaled nitric oxide) is a
well-established biomarker for T2 airway inflammation driven by
T-helper cells type 2 (Th2). IL-13 and IL-4 are two inflammatory
cytokines produced by Th2 cells. These cytokines induce the release
of nitric oxide (NO) from airway epithelial cells which can be
measured in expired breath (FeNO).
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 inhaled corticosteroids (ICS) plus LABA. STRATOS 1
also explored potential biomarkers to identify patients with an
enhanced response to tralokinumab and identified FeNO as the lead
biomarker. STRATOS 2 sought to validate this.
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 designed to
evaluate the effect of tralokinumab administered subcutaneously
every 2-weeks on airway inflammation 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 AstraZeneca in Respiratory Disease
Respiratory disease is one of AstraZeneca's main therapy areas, and
the Company has a growing portfolio of medicines that reached more
than 18 million patients in 2016. AstraZeneca's 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.
The Company is building on a 40-year heritage in respiratory
disease and AstraZeneca's capability in inhalation technology spans
both pMDIs and dry powder inhalers, as well as the innovative
Aerosphere Delivery Technology. The company's biologics include
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 and secondary endpoints. AstraZeneca's 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 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.
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Adrian Kemp
Company Secretary
AstraZeneca PLC
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.
Date: 1
November 2017
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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